Safety

Enforcement Report for February 15, 2012

February 15, 2012
12-07
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
PRODUCT
Carolina's brand Pan de Torta, baked goods, packed in 16 oz. clear plastic bag, UPC 911600164. Recall # F-0695-2012
CODE
Date codes 02/15/12 and before
RECALLING FIRM/MANUFACTURER
Recalling Firm: JKS Wholesalers, Beltsville, MD, by telephone starting on December 23, 2011 and by press release on January 18, 2012.
Manufacturer: El Latino Bakery, Washington,DC. Firm Initiated recall is ongoing.
REASON
Baked goods contain milk which was not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
400
DISTRIBUTION
D,C; MD, VA, NJ, NY
PRODUCT
  1. How Sweet It Is Peanut Butter Buckeye!, Ingredients: Peanuts, sugar, hydrogenated vegetable oil, coca, cocoa oil, corn syrup, salt molasses, mono and diglycerides, 32 count Nt. wt 1.1 oz., individual candies are cellophane wrapped with a bar code. UPC Code: 69087100460. Recall # F-0696-2012;
  2. How Sweet It Is Peanut Butter Smoothie!, Ingredients: Peanuts, sugar, hydrogenated vegetable oil, coca, cocoa oil, corn syrup, salt molasses, mono and diglycerides, 32 Count Nt. Wt 1.1 Oz., individual candies are cellophane wrapped with a bar code. UPC Code: 69087100460. Recall Number: F-0697-2012
CODE
Lot # 3312011 through Lot #0232012
RECALLING FIRM/MANUFACTURER
How Sweet It Is Fudge and Candy Co., East Lansing, MI, by telephone beginning January 26, 2012 and by press release and letters on January 28, 2012. FDA initiated recall is ongoing.
REASON
Product contains undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
  1. 552 boxes;
  2. 168 boxes
DISTRIBUTION
IN, MI, IN, OH, PA, TN, VA
PRODUCT
  1. Yogurt Raisins. Packaged in cellophane wrappers under the following brand names and sizes: a.) Blain's Farm & Fleet, Net Wt. 1 lb. (454g), UPC 34952-81368; b.) Blain's Farm & Fleet, Net Wt. 2.5 oz. (71g), UPC 34952-81913; c.) Eillien's, Net Wt. 1 lb 2 oz (510b), UPC 34952-57254; d.) Mills Fleet Farm, l lb. (454g), UPC 34952-35576; e.) Nutty Bros, Net Wt. 10 oz.., UPC 34952-57689 f.) Piggly Wiggly, Net Wt 1 lb. 2 oz. (510g), UPC 34952-57391 g.) Royal Snacks, Net Wt. 14 oz. (397g), UPC 34952-57156. Recall # F-0701-2012;
  2. Mills Fleet Farm Granola Mix in cellophane wrappers in NET WT 1 lb. 8 oz (680g) 24 oz packages, UPC34952-36077; and Eillien's Granola Mix in cellophane wrappers in NET WT 1 lb 6oz (624g), 22 oz packages, UPC 34952-56648. Recall # F-0702-2012;
  3. Cinnamon Granola Mix in Nt Wt 1 lb. 2 oz (510g), 18 oz in cellophane wrappers labeled for Mills Fleet Farm, UPC 34952-36076 and for Eillien's, UPC 34952-36076. Recall # F-0703-2012
CODE
"Sell by" date prior to December 22, 2012
RECALLING FIRM/MANUFACTURER
Eillien's Candies, Inc., Green Bay, WI, by press release on December 22, 2011, by telephone, emails and faxes on December 22-23, 2011 and telephone and letter on December 27, 2011. Firm initiated recall is ongoing.
REASON
Product may contain undeclared Yogurt Covered Peanuts mixed with Yogurt Covered Raisins.
VOLUME OF PRODUCT IN COMMERCE
27,888 lbs of yogurt raisins
DISTRIBUTION
IA, IL, MI, MN, SD, WI
PRODUCT
  1. A CUT ABOVE Taco Cut Shredded Lettuce, 5 lb bags packed 4 per case. Recall # F-0704-2012;
  2. A CUT ABOVE Baby Spinach, 1 lb bags. Recall # F-0705-2012;
  3. A CUT ABOVE Cantaloupe Cubes, 5 lb bags. Recall # F-0706-2012;
  4. A CUT ABOVE Carrot Sticks, 5 lb bags. Recall # F-0707-2012;
  5. A CUT ABOVE Carrot - Match Sticks, 4 packages of 5 lb bags per case. Recall # F-0708-2012;
  6. A CUT ABOVE Celery Sticks, 5 lb bags. Recall # F-0709-2012;
  7. A CUT ABOVE Cut Broccoli Florets, 3 and 5 lb bags. Recall # F-0710-2012;
  8. A CUT ABOVE Shredded Cabbage – Red, 5 lb bags. Recall # F-0711-2012;
  9. A CUT ABOVE Cut Cauliflower Florets, 3 and 5 lb bags. Recall # F-0712-2012;
  10. A CUT ABOVE Shredded Carrots, 1 and 5 lb bags. Recall # F-0713-2012;
  11. A CUT ABOVE Cut Caesar Salad Mix, 5 lb bags. Recall # F-0714-2012;
  12. A CUT ABOVE Cut Cole Slaw, 5 lb bags. Recall # F-0715-2012;
  13. A CUT ABOVE Cut Regular Lettuce, 5 lb bags. Recall # F-0716-2012;
  14. A CUT ABOVE Cut Romaine, 2 lb bags. Recall # F-0717-2012;
  15. A CUT ABOVE Cut Salad Mix, 5 lb bags. Recall # F-0718-2012;
  16. A CUT ABOVE Diced Bell Pepper, 3 and 5 lb bags. Recall # F-0719-2012;
  17. A CUT ABOVE Sliced Cucumbers, 5 lb bags. Recall # F-0720-2012;
  18. A CUT ABOVE Diced Celery, 5 lb bags. Recall # F-0721-2012;
  19. A CUT ABOVE Diced Onion, 5 lb bags. Recall # F-0722-2012;
  20. A CUT ABOVE Diced Potato, 5 lb bags. Recall # F-0723-2012;
  21. A CUT ABOVE Honeydew Cubes, 5 lb bags. Recall # F-0724-2012;
  22. A CUT ABOVE Jicama Sticks, 5 lb bags. Recall # F-0725-2012;
  23. A CUT ABOVE Pineapple Bits, 5 lb bags. Recall # F-0726-2012;
  24. A CUT ABOVE Shredded Cabbage - Green, 5 lb bags. Recall # F-0727-2012;
  25. A CUT ABOVE Sliced Grapefruit, 5 lb bags. Recall # F-0728-2012;
  26. A CUT ABOVE Sliced Green Bell Pepper, 5 lb bags. Recall # F-0729-2012;
  27. A CUT ABOVE Sliced Radish, 5 lb bags. Recall # F-0730-2012;
  28. A CUT ABOVE Sliced Red Apples, 2.8 oz and 5 lb bags. Recall # F-0731-2012;
  29. A CUT ABOVE Sliced Red Onions, 5 lb bags. Recall # F-0732-2012;
  30. A CUT ABOVE Sliced Yellow Onions, 5 lb bags. Recall # F-0733-2012;
  31. A CUT ABOVE Watermelon Cubes, 5 lb bags. Recall # F-0734-2012;
  32. A CUT ABOVE Sliced Oranges, 5 lb bags. Recall # F-0735-2012;
  33. A CUT ABOVE Sliced Carrots, 5 lb bags. Recall # F-0736-2012
CODE
USE BY 12 13 thru 12 26
RECALLING FIRM/MANUFACTURER
Nicho Produce Co., Inc., Edinburg, TX, by letter dated December 9, 2011 and December 19, 2011. FDA initiated recall is ongoing.
REASON
The product has the potential to be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
9,829.5 pieces
DISTRIBUTION
TX
PRODUCT
DRIED DATE, Net Wt: 12 oz (340G), UPC 6 868978 724670, Produce of P.R.C. The product is packed in a sealed flexible plastic bag. --- NUTRITION FACTS: Serving Size 40g, Servings per Bag: About 10. Recall # F-0737-2012
CODE
The product is uncoded.
RECALLING FIRM/MANUFACTURER
Domega NY International Co Ltd, Brooklyn, NY, by telephone on October 19, 2011 and by letter dated October 21, 2011.
Manufacturer: JIANGMEN XINHUI PARKSUN FOOD CO., LTD, Jiangmen City, China. New York Initiated recall is complete.
REASON
The product contained undeclared sulfites (394.4 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
350 cases (50 - 12 oz/340g bags per case)
DISTRIBUTION
NY
PRODUCT
  1. Rice crackers. Bin Bin brand, "Snow Rice Crackers". Product labeling reads in part: "Bin Bin***Snow Rice Crackers***Net wt: 5.3 oz. (150G)***UPC code 8 852098 700124. Recall # F-0738-2012;
  2. Rice crackers. Bin Bin brand, "Rice Crackers". Product labeling reads in part:"Bin Bin***Rice Crackers***Net Wt: 15.8 oz. (450G), UPC code 8852098701510. Recall # F-0739-2012
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gemini Food Corporation Inc., City of Industry, CA, by press release on January 31, 2012.
Manufacturer: Namchow Thailand Ltd, Bangkok, Thailand. FDA initiated recall is ongoing.
REASON
The product contains undeclared eggs based on the Canadian Food Inspection Agency's analysis.
VOLUME OF PRODUCT IN COMMERCE
3686 cases
DISTRIBUTION
Nationwide
PRODUCT
  1. Aunt Jemima Buttermilk Pancakes 12 count Keep Frozen Net Wt. 14.8 OZ (420g) UPC 19600-05100; Serving Size 3 pancakes (105g). Recall # F-0743-2012;
  2. Aunt Jemima Whole Grain Pancakes 12 count Keep Frozen Net Wt. 14.5 OZ (411g) UPC 19600-06040; Serving Size 3 pancakes (103g). Recall # F-0744-2012;
  3. Aunt Jemima Low Fat Pancakes 12 count Keep Frozen Net Wt. 14.5 OZ (411g) UPC 19600-05100; Serving Size 3 pancakes (103g). Recall # F-0745-2012;
  4. Aunt Jemima Confetti Pancakes 12 count Keep Frozen Net Wt. 14.8 OZ (420g) UPC 19600-05955; Serving Size 3 pancakes (105g). Recall # F-0746-2012;
  5. Aunt Jemima Oatmeal Pancakes 12 count Keep Frozen Net Wt. 14.8 OZ (420g) UPC 19600-05490; Serving Size 3 pancakes (105g). Recall # F-0747-2012;
  6. Aunt Jemima Homestyle Pancakes 12 count Keep Frozen Net Wt. 14.8 oz (420g) UPC 19600-05910; Serving Size 3 pancakes (105g). Recall # F-0748-2012
CODE
Recommended Use By Date between November 1, 2011 up to and including October 16, 2012.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pinnacle Food Corp., Mountain Lakes, NJ, by press release and letter on January 27, 2012.
Manufacturer: Pinnacle Foods Group, Jackson,TN. Firm initiated recall is ongoing.
REASON
Frozen pancakes may contain undeclared soy protein.
VOLUME OF PRODUCT IN COMMERCE
764,634 cases US 83,246 cases Canada
DISTRIBUTION
Nationwide and Canada
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
PRODUCT
Safie's, Hand Packed, Home Style Sweet Pickled Beets Betterraves Marinees Sucrees, 1 Liter. Recall # F-0665-2012
CODE
Best Before Aug 18, 2013 or later.
RECALLING FIRM/MANUFACTURER
Safie Specialty Foods Co., Inc., Chesterfield Township, MI, by telephone and letters dated December 30, 2011. Firm Initiated recall is ongoing.
REASON
Complaints of glass fragments found in product.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Canada
PRODUCT
BIGS SUNFLOWER SEEDS, Valsic Dill Pickle Flavor, Net Wt 5.35 oz, (152g), Ingredients: Sunflower Seeds, Salt, Dill Seasoning (Maltodextrin, Sodium Diacetate, Whey, Monosodium Glutamate, natural Flavor, Citric Acid, Spices, Dehydrated Garlic, Dehydrated Onion, Disodium Inosinate and Disodium Guanylate, Vlasic Kosher Dill Pickle Brine, Water, Sunflower Oil, Contains: Milk.
  1. Item #55002 12 Ct/5.35 oz BIGS Dill Pickle Sunflower Seeds, Case UPC #10896887002209, Bag UPC #8968870022202;
  2. Item #55007 48 Ct (4/12 Ct)/5.35 oz BIGS Dill Pickle Sunflower Seeds (Case UPC #10896887002261, Bag UPC #8968870022202;
  3. Item #55043 8 Ct/5.35 oz BIGS Dill Pickle Sunflower Seeds, Case UPC #60896887002204, Bag UPC #8968870022202. Recall # F-0693-2012
CODE
  1. Case Code BEST BY 08DEC2012, BEST BY 09DEC2012; Bag Code BEST BY 08DEC2012, BEST BY 09DEC2012;
  2. Case Code BEST BY 08DEC2012, BEST BY 09DEC2012, Bag Code BEST BY 08DEC2012, BEST BY 09DEC2012;
  3. Case Code BEST BY 08DEC2012, BEST BY 09DEC2012, Bag Code BEST BY 08DEC2012, BEST BY 09DEC2012
RECALLING FIRM/MANUFACTURER
Ryt-Way Industries, Inc., Lakeville, MN, by press release on January 11, 2012 and letter dated January 13m 2012. Firm initiated recall is ongoing.
REASON
Recall due to an undeclared soy allergen.
VOLUME OF PRODUCT IN COMMERCE
12 ct - 4925 cases, 48 (4/12 ct) ct - 144 cases, 8 ct- 73 cases
DISTRIBUTION
Nationwide
PRODUCT
Brown Rice Baby Cereal, 12 units/cases, Use by: 24 March 2013. The front panel reads in part ***Healthy Times* WHOLE GRAIN* Brown Rice* Cereal for*Baby* SOY FREEEASY TO DIGEST* SINGLE 1 GRAIN***. The side panel reads in part ***Ingredients:* Organic Whole Grain Brown Rice Flour***UPC: 048685 021880. Recall # F-0694-2012
CODE
Lot: 13011 1505-1557
RECALLING FIRM/MANUFACTURER
Recalling Firm: Healthy Times Inc., Poway, CA, by letter on November 25, 2011.
Manufacturer: R. J. Van Drunen and Sons Inc., Momence, IL. Firm initiated recall is ongoing.
REASON
The recall was initiated because Healthy Times has confirmed that the Brown Rice Cereal may contain undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
1992 units (166 cases)
DISTRIBUTION
CA, NH
PRODUCT
Feel Your Oats Bread Mix. Recall # F-0699-2012
CODE
Lot Number 04501101
RECALLING FIRM/MANUFACTURER
War Eagle Mill, Hindsville,AR, by telephone on January 5, 2012. Firm initiated recall is ongoing.
REASON
Small pieces of glass have been found in a small number of bags of Feel Your Oats Bread Mix.
VOLUME OF PRODUCT IN COMMERCE
193 bags
DISTRIBUTION
Nationwide
PRODUCT
Rich Fields brand Butter Cookies. Item 9100385 047 11 04 13 and item 9100401 036 11 04 07. Recall # F-0740-2012
CODE
APR 12 2012 and APR 6 2012
RECALLING FIRM/MANUFACTURER
Rite Aid Corp., Camp Hill, PA, via email on October 22, 2011 and issued a press release on October 29, 2011. Firm initiated recall is ongoing.
REASON
Possible microbial contaminant.
VOLUME OF PRODUCT IN COMMERCE
1,704,006
DISTRIBUTION
Nationwide
PRODUCT
Martinelli's Gold Medal Sparkling Cider; 6 pack shrink bundled, 8.4 ounce 250 mL glass bottles in gold colored box. 1 Item 46256, 6 bottles per bundled shrink wrapped pack with 4-6 packs per tray; 2 Item 12256 (same bottle), loose pack of 12 bottles per tray; UPC for case: 4124499932; UPC for six pack: 412446256; UPC for single bottle: 4124400256. Recall # F-0742-2012
CODE
Best By dates: 11 APR 2014, 12 APR 2014, 13 APR 2014, 14 APR 2014
RECALLING FIRM/MANUFACTURER
S Martinelli & Co., Watsonville,CA, by press release and telephone on December 29, 2011. Firm initiated recall is ongoing.
REASON
Glass fracture occurs at the top of the bottle when a twist-off crown is removed and as a result, some glass pieces may fall into the cider.
VOLUME OF PRODUCT IN COMMERCE
1 5,373 trays; 2 432 trays
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Calidad Premium EL FARO Langastino Crudos Cangalodos; Frozen Raw Shrimp:
  1. 31/35
  2. 36/40
  3. 41/50
  4. 31/35
  5. 36/40
Product Must be cooked. Product of Honduras. Recall Number: F-0750-2012
CODE
  1. Cold storage lot# 69624, Carton lot 1-ECSI-20110624-0611
  2. cold storage lot# 69624: carton lot# ***1-ECSI-20110624 0611***
  3. cold storage lot# 69625: carton lot# ***LOTE 1-EFO-A3 110611***
  4. cold storage lot# 69626: carton lot# ***LOTE 1-PVS-A6 150611***
  5. cold storage lot# 69627: carton lot# ***LOTE 1-ISR-23 240611***
DISTRIBUTION
  1. EL FARO - 74 ctns X 10 bx X 5 lbs (50 lb ctn) (size 31/35)
  2. EL FARO- 236 ctns X 10 bx X 5 lbs (50 lb ctn) (size 36/40)
  3. EL FARO- 267 ctns X 10 bx X 5 lbs (50 lb ctn) (size 41/50)
  4. MARITTIMO- 196 ctns X 10 bx X 5 lbs (50 lb ctn) (size 31/35)
  5. MARITTIMO- 27 ctns X 10 bx X 5 lbs (50 lb ctn) (size 36/40)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fanco Trading Co, Burlingame, CA, by telephone the week of January 16, 2012.
Manufacturer: Empacadora de Camarones Santa Ines, S de R.L., Choluteca, Honduras. FDA initiated recall is complete.
REASON
FDA Import Sample was positive for Salmonella.
VOLUME OF PRODUCT IN COMMERCE
591 cartons
DISTRIBUTION
CA
PRODUCT
Chocolate Favorites Sugar-Free Chocolates Net Wt. 8 oz. (226g) containing assortment of: Milk Chocolate Coconut Cluster, Milk Chocolate Pecan Caramel, Milk Chocolate Caramel, Milk Chocolate Almond Cluster, Milk Chocolate Vanilla Marshmallow, and Milk Chocolate Cashew Cluster. *ADDS A NEGLIGIBLE AMOUNT OF SUGAR CONTAINS: MILK, SOY, PECANS, ALMONDS, CASHEWS, EGGS, SUITES, AND FISH. Diabetics should consukt your physician prior to consumption. Recall # F-0751-2012
CODE
1327 (Sticker on back of box)
RECALLING FIRM/MANUFACTURER
Morley Candy Makers, Inc., Clinton Township, MI, by telephone and email on January 6, 2012. Firm initiated recall is ongoing.
REASON
Product labeled "Sugar Free Pecan Torties" that actually contained Cashew Titans which are not "Sugar Free".
VOLUME OF PRODUCT IN COMMERCE
300 boxes
DISTRIBUTION
CA
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
PRODUCT
Winn-Dixie Assorted Flavor Gummi Bears sold in self-serve bulk candy display in produce department of select stores. The product is in a Plexiglass bulk candy display tube. Bulk product at retail is labeled in part: "***PLU # 3210***GUMMI BEARS***$2.49 LB***INGREDIENTS: CORN SYRUP, SUGAR, GELATIN, CITRIC ACID, NATURAL AND ARTIFICIAL FLAVORS, FD&C RED 40, YELLOW 6, YELLOW 5, BLUE 1, CARNAUBA WAX.***NUTRITIONAL FACTS***SERVING SIZE: 15 pieces (40g) CALORIES 130***FAT CALORIES 6***" Shelf life of product is 9 months in the bag and 6 months in the bulk bin. Recall # F-0664-2012
CODE
Unit: 20076500800215
RECALLING FIRM/MANUFACTURER
Recalling Firm: Winn Dixie Stores, Inc., Jacksonville,FL, by press release on December 13, 2011.
Manufacturer: Sunrise Confections, El Paso,TX. Firm initiated recall is ongoing.
REASON
Recall due to the possibility of metal contamination.
VOLUME OF PRODUCT IN COMMERCE
31.2 lbs
DISTRIBUTION
FL, LA
PRODUCT
1/4 Sheet Vanilla Flavored Pre-Soaked Sponge Cake Artificially Flavored 1/4 sheet size code #00405, Net Case Wt: 29 lb 15 oz --- and 8" size code #62938, Net Case Wt: 17 lb 6 oz. UPC: 00049800004054. Product is packaged in a plastic container. Recall # F-0666-2012
CODE
Product produced after July 10, 2011.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rich Products Corp., Buffalo,NY, by letters on January 5, 2012, and January 12, 2012 and by press release on January 6, 2012 and January 19, 2012.
Manufacturer: Productos Richs Sa De Cv, Ocoyoacac, Edo de Mexico, Mexico. Firm initiated recall is ongoing.
REASON
Small plastic fragments from the packaging were found on top of the product. The size of the fragments range from (one fourth) to (three fourths) inches.
VOLUME OF PRODUCT IN COMMERCE
32828 cases of 1/4 sheet cakes, 16414 cases of 8" cakes
DISTRIBUTION
Nationwide
PRODUCT
Smoked Salmon Jerky Peppered is sold under the brand name Alaska's Best. There are 144 packages/ 1 oz per master box and the packages can be observed with the following UPC: 0 40668 00876 5; 0 40668 00436 1; and 0 40668 00415 6; There are 144 packages/ 2.12 oz per master box and the package has the UPC 0 40668 00471 2; There are 50 packages/ 3 oz. per master box and the package has the UPC 0 23882 83066 4; There are 15 packages/ 12 oz. per master box and the package has the UPC 0 40668 00481 1. The manufacturing label is quoted as: "***Trapper's Creek Smoking Company***A.B. Slm Peppered Jerky***Keep STORE ON DRY COOL PLACE (70 F.)***". The customer's labeled is quoted as: "***Alaska's Best***Salmon Jerky***PEPPERED King Salmon***NET WT. 1 OZ.***". The customer's labeled is quoted as: "***Alaska's Best***Salmon Jerky***PEPPERED***INGREDIENTS: WILD SALMON, SALT, BROWN SUGAR, CORN SYRUP SOLIDS, NATURAL FLAVORING, SPICES, GARLIC POWDER. (CONTAINS: FISH)***NET WT. 2.12 OZ.***". The customer's labeled is quoted as: "***PEPPER GARLIC SALMON JERKY***INGREDIENTS: WILD SALMON FILLETS, SALT, SUGAR, POTASSIUM LACTATE, CORN SYRUP SOLIDS, SPICES, BLACK PEPPER, GARLIC POWDER, NATURAL FLAVORING, SODIUM ERYTHROBLAST. (CONTAIN FISH)***NET WT. 3 OZ.***". The customer's labeled is quoted as: "***Alaska's Best***King Salmon Jerky***PEPPERED King Salmon***INGREDIENTS: WILD SALMON, SALT, BROWN SUGAR, CORN SYRUP SOLIDS, NATURAL FLAVORING, SPICES, GARLIC POWDER. (CONTAINS: FISH)***NET WT. 12 OZ***". Recall #F-0698-2012
CODE
LOT Code: JP01011. The retail packages also bear the following date codes: 1 oz. packages are code dated: 10/26/2011; 2.12 oz packages are code dated: 10/28/2011; 3 oz packages are code dated: 10286 (year, Julian date); 12 oz packages are code dated: 10/28/2011.
RECALLING FIRM/MANUFACTURER
Copper River Smoking Co., Puyallup, WA, by telephone and followed up with emails on December 7th, 2010. FDA Initiated recall is ongoing.
REASON
Product has a water activity of .86 instead of .85.
VOLUME OF PRODUCT IN COMMERCE
720 Pkgs (1 oz); 432 Pkgs (2.12 oz); 500 Pkgs (3 oz); 15 Pkgs (12 oz)
DISTRIBUTION
AK, WA, and Switzerland
PRODUCT
AquaActive Negative ORP & Alkaline Tablet With Added Inulin & L-Leucine Contains Four Essential Electrolytes 60 Effervescent Tablets 230mg FDA Registered Medical Device 3008514084. Recall # F-0741-2012
CODE
All lots distributed from 11/01/2010 - 12/16/2011.
RECALLING FIRM/MANUFACTURER
Good Herbs, Inc., Troy, MI, by letter was sent on December 28, 2011. Firm Initiated recall is ongoing.
REASON
The FDA medical device registration declared on the label was not valid. The firms medical device registration was withdrawn and the AquaActive product label still contained the statement FDA Registered Medical Device.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,500 bottles
DISTRIBUTION
Nationwide
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
 
RECALLS PENDING CLASSIFICATION: DRUGS
PRODUCT
OFIRMEV (acetaminophen) injection, 1000mg/100ml, For Intravenous Use Only, Rx Only
CODE
Lot V005710
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cadence Pharmaceuticals, San Diego, CA92130-3583
Manufacturing Firm:Baxter Healthcare Corporation, Cleveland, Mississippi
REASON FOR RECALL
Presence of Particulate Matter
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
PRODUCT
Cricothyroidotomy Convenience Kit (Crickit)
  1. Crickit Product Code10-0017; Crickit is found inside the affected lot numbers of Medic Trauma Pack Kit:
  2. BLK/Black: Part number 80-0070;
  3. ODG/Green: Part number: 80-0071;
  4. COY/Tan: Part number 80-0072; and 5) DUC/Camouflage: Part number 80-0096; as one of the components. Recall # D-1196-2012
CODE
  1. Lot numbers: 21096, Exp. 03/14; 21420, Exp. 04/14; 21421, Exp.05/14; 21422, Exp. 05/14; 21423, Exp. 06/14; 21424, Exp. 06/14; 21910, Exp. 08/14; 21911, Exp. 08/14; 21912, Exp. 09/14; 21913, Exp. 09/14; 22151, Exp. 10/14; 22152, Exp. 11/14; 22289, Exp. 12/14; 22290, Exp. 12/14; 22344, Exp. 01/15; 22345, Exp. 01/15; 22346, Exp. 03/13; 22347, Exp. 03/13; 22725, Exp. 09/12; 22726, Exp. 09/12; 22727, Exp. 09/12; 22728, Exp. 09/12; 22946, Exp. 01/13; 22947, Exp. 01/13; 22948, Exp. 01/13; 22949, Exp. 01/13;
  2. Lot numbers: 80-0070093009, 80-0070092810, 80-0070092210, 80-0070080609, 80-0070072810, 80-0070072710, 80-0070071510, 80-0070070710, 80-0070063009, 80-0070061710, 80-0070060110, 80-0070050409, 80-0070040910, 80-0070032211SX, 80-0070031210, 80-0070022211X, 80-0070021810, 80-0070020910, 80-0070012510, 80-0070012210, 80-0070011310, 80-0070120910, 80-0070120710, 80-0070112309, 80-0070111210, 80-0070102910, 80-0070102810, 80-0070102210, 80-0070101310 & 80-0070100810, Exp. 09/15;
  3. Lot numbers: 80-0071092909, 80-0071090910, 80-0071090109, 80-0071072710, 80-0071071310, 80-0071041411SX, 80-0071012810, 80-0071012510, 80-0071120910 & 80-0071102910, Exp. 09/15;
  4. Lot numbers: 80-072092909, 80-0072092710, 80-0072090810, 80-0072090109, 80-0072083109, 80-0072082310, 80-0072081109, 80-0072081009, 80-0072080709, 80-0072050710, 80-0072050409, 80-0072042110, 80-0072041510, 80-0072041410, 80-0072031710, 80-0072012910, 80-0072012810, 80-0072012010, 80-0072110810, 80-0072101210 & 80-0072100410, Exp. 09/15;
  5. Lot numbers: 80-0096061710, 80-0096050409, 80-0096041610, 80-0096031810, 80-0096012910, 80-0096012810, 80-0096012510, 80-0096010710, 80-0096120910, 80-0096120909, 80-0096112409, 80-0096110810, 80-0096101509, 80-0096101210 & 80-0096100410: Exp. 09/15).
RECALLING FIRM/MANUFACTURER
North American Rescue, Greer, SC, by letter on May 2, 2011, press release on February 1, 2012, and an amended letter on February 2012. Firm initiated recall is complete.
REASON
Microbial Contamination of Non-Sterile Products: The Kit contains Povidone Iodine Prep Pads that are being recalled by the Triad Group because they were found to be contaminated with the bacteria, Elizabethkingia meningoseptica.
VOLUME OF PRODUCT IN COMMERCE
26,000 kits
DISTRIBUTION
Nationwide and Internationally
 
FIELD CORRECTIONS: DRUGS - CLASS II
PRODUCT
FLUDARA (fludarabine phosphate) for injection, 50 mg, Single Dose Vial, For Intravenous Use Only, Rx only. NDC Number 50419-511-06. Recall # D-1203-2012
CODE
Lot Number 2020898 (Expiry Date June 2013)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Genzyme Corp, Cambridge, MA, by letters on January 31, 2012 and February 1, 2012.
Manufacturer: Ben Venue Laboratories Inc., Bedford, OH. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility: Based on joint FDA/EMA inspection conducted at the manufacturer Ben Venue Laboratories in Bedford, Ohio, in November 2011, and the GMP deficiencies identified.
VOLUME OF PRODUCT IN COMMERCE
1876 packs (9380 vials)
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0408-12
CODE
Units: W038111291039; W038111318192
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by facsimile and telephone on September 27, 2011. Firm initiated recall is complete
REASON
Blood products, for which the quality control testing was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
PRODUCT
  1. Cryoprecipitated AHF. Recall # B-0551-12;
  2. Red Blood Cells. Recall # B-0552-12
CODE
  1. Unit: 1049261;
  2. Units: 1049261, 2022132
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on February 15, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA, SC
PRODUCT
  1. Cryoprecipitated AHF. Recall # Recall # B-0553-12;
  2. Red Blood Cells Leukocytes Reduced. Recall # B-0554-12;
  3. Plasma Cryoprecipitated Reduced. Recall # B-0555-12
CODE
1, 2 and 3 Unit: 003LF63081
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by facsimile on September 22, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was diagnosed with toxic fungus Nigerlysin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC, GA
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0556-12
CODE
Unit: W036511154835
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by fax on November 9, 2011. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
PRODUCT
  1. Red Blood Cells Leukocytes Reduced. Recall # B-0557-12;
  2. Platelets. Recall # B-0558-12
CODE
1 and 2 Unit: W0352113064466
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on November 8, 2011 and letter on December 6, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ, TX
PRODUCT
  1. Red Blood Cells Leukocytes Reduced. Recall # B-0559-12;
  2. Cryoprecipitated AHF. Recall # B-0560-12
CODE
1 and 2 Unit: W0352112197543
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by electronic notification on December 5, 2011, fax on December 5, 2011 and letter on December 6, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria, NJ, TX
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0563-12
CODE
Units: W115911046158; W115911043989
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by email on December 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to a malaria endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
PRODUCT
Source Plasma. Recall # B-0564-12
CODE
Units: 11BWAF4730; 11BWAF3784; 11BWAF7776
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Bellingham, WA, by electronic mail on November 16, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Austria
PRODUCT
  1. Red Blood Cells. Recall # B-0565-12;
  2. Red Blood Cells Leukocytes Reduced. Recall # B-0566-12
CODE
  1. Unit: 021KR16676;
  2. Units: 021KR24813, 021KR31207
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by facsimile on June 22, 2007 and by letter dated June 28, 2007. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibodies to human T lymphotropic virus, types I and II (anti-HTLV-I/II), but were collected from an ineligible donor due to previous positive testing for anti-HTLV-I/II, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OR, MD
PRODUCT
Red Blood Cells. Recall # B-0570-12
CODE
Units: 5124375, 5123098
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on April 8, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0571-12
CODE
Unit: 21FV18243
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by telephone on March 23, 2007 and by letters dated April 2, 2007 and May 10, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
  1. Red Blood Cells. Recall # B-0572-12;
  2. Fresh Frozen Plasma. Recall # B-0573-12
CODE
1 and 2 Unit: W036811197484
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Hialeah, FL, by telephone and letter on November 28, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
PRODUCT
  1. Red Blood Cells Leukocytes Reduced. Recall # B-0574-12;
  2. Platelets Pooled Leukocytes Reduced. Recall # B-0575-12;
  3. Fresh Frozen Plasma. Recall # B-0576-12
CODE
1 and 3 Unit: 2302674;
) Unit: 2907904
RECALLING FIRM/MANUFACTURER
Community Blood Centers/S Florida Inc., Lauderhill, FL, by telephone and letter on November 29, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0577-12
CODE
Unit: W158011101034
RECALLING FIRM/MANUFACTURER
Arup Laboratories, Inc., Sandy, UT, by electronic mail on November 30, 2011 and letter on December 13, 2011. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
UT
PRODUCT
Cornea. Recall # B-0578-12
CODE
Units: 111139OSCN, 111139ODCN:
RECALLING FIRM/MANUFACTURER
Indiana Lions Eye and Tissue Transplant Bank, Indianapolis, IN, by telephone on October 27, 2011 and October 31, 2011. Follow-up notification was by letters on October 31, 2011. Firm initiated recall is complete.
REASON
Human tissue allografts, recovered from a donor whose eligibility was not properly evaluated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MA, IN
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0579-12
CODE
Unit: 8815100 (Parts 1 & 2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone on February 16, 2006 and by letter dated February 26, 2006.
Manufacturer: Blood Centers of the Pacific, Redding, CA. Firm initiated recall is complete.
REASON
Blood products, for which the sterility may have been compromised during manufacturing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
PRODUCT
  1. Cryoprecipitated AHF. Recall # B-0583-12;
  2. Red Blood Cells. Recall # B-0584-12
CODE
1 and 2 Unit: 4132630
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on November 14, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA, Israel
PRODUCT
Cornea. Recall # B-0587-12
CODE
Unit: 20110479R1
RECALLING FIRM/MANUFACTURER
Lifepoint, Inc., Charleston,SC, by letters on August 25, 2011 and on August 29, 2011. Firm initiated recall is complete.
REASON
Human tissue allografts, recovered from a donor whose eligibility was not properly evaluated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0588-12
CODE
Unit: 6055672
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Fairfield, CA, by telephone on February 10, 2006 and by letter dated February 15, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0589-12
CODE
Units: 2910743, 2910744, 2910745
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on February 1, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose hematocrit determinations were performed incorrectly, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0590-12
CODE
Unit: 8749509
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on January 20, 2006 and by letter dated February 6, 2006.Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0601-12
CODE
Unit: W038111267557
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on September 14, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a piercing within 12 months of the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
PRODUCT
Red Blood Cells Leukocytes reduced, Recall # B-0602-12
CODE
Unit: 003LL78916
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Southern Region, Douglasville, GA, by facsimile and electronic letter on November 22, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Al, GA
PRODUCT
Platelets Pheresis Leukocytes reduced, Recall # B-0604-12
CODE
Units: W069111139652; W069111139501; W069111129373; W069111129619
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Flowood, MS, by facsimile on October 11, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MS
PRODUCT
Red Blood Cells. Recall # B-0606-12
CODE
Unit: W036810016261
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South FL, Inc., Orlando, FL, by telephone and letter on November 1, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland, NY
PRODUCT
Red Blood Cells. Recall # B-0607-12
CODE
Unit: W120611302296
RECALLING FIRM/MANUFACTURER
Michigan Blood, Saginaw, MI, by facsimile on November 30, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
PRODUCT
FLUVIRIN (Influenza Virus Vaccine) 2010-2011 Formula Multidose Vials. Recall # B-0631-12
CODE
Lot: 111812P1
RECALLING FIRM/MANUFACTURER
Novartis Vaccines and Diagnostics Limited, Liverpool, UK, by letter dated December 17, 2010. Firm initiated recall is complete.
REASON
Fluvirin (Influenza Virus Vaccine) 2010-2011 Formula Multidose Vial, with the possibility of a cracked vial neck, was distributed.
VOLUME OF PRODUCT IN COMMERCE
78,832 vials
DISTRIBUTION
Nationwide
PRODUCT
Human cornea. Recall # B-0632-12
CODE
Units: 105013OD, 105013OS, Expiration date 01/14/2006.
RECALLING FIRM/MANUFACTURER
San Diego Eye Bank, San Diego, CA, by letters dated July 6, 2006. Firm initiated recall is complete.
REASON
Human corneas, recovered from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, TX
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
PRODUCT
  1. Source Leukocytes. Recall # B-0561-12;
  2. Recovered Plasma. Recall # B-0562-12
CODE
1 and 2 Unit: W0352112197543
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by electronic notification on December 5, 2011, fax on December 5, 2011 and letter on December 6, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria, NJ, TX
PRODUCT
Plasma. Recall # B-0585-12
CODE
Unit: 4132630
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on November 14, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of high-risk behavior, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA, Israel
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0586-12
CODE
Units: 36FR30507, 36FR30614, 36GT24029
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Columbia,SC, by telephone on July 8, 2010 and by letter dated July 23, 2010. Firm initiated recall is complete.
REASON
Blood products, which were labeled with an incorrect volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
SC
PRODUCT
Recovered Plasma. Recall # B-0595-12
CODE
Units: W0415110415312, W0415110063843
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc. dba United Blood Services, Lubbock, TX, by letters dated November 25, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who previously contracted hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland,
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0599-12
CODE
Unit: W043811321284
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by telephone on November 4, 2011 and letter dated November 14, 2011. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0600-12
CODE
Unit: W051511076178
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul,MN, by letter on December 6, 2011.
Manufacturer: Memorial Blood Centers – Duluth, Duluth,MN. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with Hemachromatosis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
PRODUCT
Recovered Plasma. Recall # B-0603-12
CODE
Unit: 003LL78916
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Southern Region, Douglasville, GA, by facsimile and electronic letter on November 22, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Al, GA
PRODUCT
Recovered Plasma. Recall # B-0605-12
CODE
Unit: W036810016261
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South FL, Inc., Orlando, FL, by telephone and letter on November 1, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland, NY
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0608-12
CODE
Units: W037711178794, W037711184734
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by telephone on November 7, 2011. Firm initiated recall is complete
REASON
Blood products, which were labeled with an incorrect volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
PRODUCT
  1. Red Blood Cells Leukocytes Reduced. Recall # B-0609-12;
  2. Platelets Pooled Leukocytes Reduced Irradiated. Recall # B-0610-12
CODE
  1. Unit: W120611282699;
  2. Unit: W120611382175
RECALLING FIRM/MANUFACTURER
Michigan Blood, Saginaw, MI, by facsimile on October 27, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with an elevated body temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
PRODUCT
Recovered Plasma. Recall # B-0611-12
CODE
Unit: 021LV60639
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by electronic notification on November 23, 2011 and by letter dated November 23, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS I
PRODUCT
Bassinet Models: BSNT/01; BSNT/02, BSNT/03, BSNT/04 The Nemschoff Perinatal Bassinet products are wheeled carts with a top tray intended for an infant tray with mattress. The bassinets are intended for medical purposes that consist of a bed designated for the use of a pediatric patient. Recall # Z-0832-2012
CODE
Manufactured between 11/21/2003 and 04/04/2008. Bassinet tubs manufactured between 11/21/2003 to present
RECALLING FIRM/MANUFACTURER
NEMSCHOFF, Sheboygan, WI, by letter and email dated October 14, 2011. Firm initiated recall is ongoing.
REASON
To correct issues with casters, door hinges, drawer slides, and the bassinet surround. Also, to add labeling to the product regarding specific instructions for cleaning the bassinet tub and drawer weight limits.
VOLUME OF PRODUCT IN COMMERCE
1214 units
DISTRIBUTION
Nationwide, and Canada
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
PRODUCT
Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector Catalog Number: 7205962. Recall # Z-0463-2012.
CODE
Lot Numbers: 830567, 830568, 830569, 863004, 868509, 868519, 875226, 875227, and 897191
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc. Endoscopy Division, Andover, MA, by letter and/or telephone on November 7, 2011.
Manufacturer: Smith & Nephew, Inc., Endoscopy Div., Mansfield, MA. Firm initiated recall is ongoing.
REASON
Manufacturing issue: The distal tip of the outer sheath (return electrode) may detach and become loose in the joint during use.
VOLUME OF PRODUCT IN COMMERCE
1743 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Pinnacle3 Radiation Therapy Planning System, software version 9.0. Model # Description 453560446041 Pinnacle3 version 9.0 English 453560446051 Pinnacle3 version 9.0 Simplified Chinese 453560446061 Pinnacle3 version 9.0 Traditional Chinese 453560446091 Pinnacle3 version 9.0 Dutch 453560446101 Pinnacle3 version 9.0 French 453560446111 Pinnacle3 version 9.0 German 453560446141 Pinnacle3 version 9.0 Italian 453560446161 Pinnacle3 version 9.0 Japanese 453560446181 Pinnacle3 version 9.0 Spanish 453560446201 Pinnacle3 version 9.0 Turkish Intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Recall # Z-0594-2012
CODE
System Code # 453560446041 453560446111 453560446041 453560446101 453560446041 453560446101 453560446041 453560446051 453560446041 453560446101 453560446041 453560446101 453560446041 453560446111 453560446041 453560446111 453560446051 453560446041 453560446141 453560446041 453560446161 453560446041 453560446161 453560446041 453560446181 453560446101 453560446041 453560446061 453560446041 453560446061 453560446041 453560446201 453560446041
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland), Inc., Fitchburg, WI, by letter dated November 16, 2011. Firm initiated recall is ongoing.
REASON
Phillips Medical Systems have recently determined that a software (Pinnacle3 Software version 9.0) nonconformance can cause incorrect beam geometry.
VOLUME OF PRODUCT IN COMMERCE
715 devices
DISTRIBUTION
Nationwide and Internationally
PRODUCT
GEMINI TF 16 PET/CT System (with software version 3.5.1 and 3.5.1.1,
  1. Model # 882470 & GEMINI TF 64 PET/CT System (with software version 3.5.1 and 3.5.1.1,
  2. Model #882471. The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Recall # Z-0805-2012
CODE
  1. Serial #'s: 7003-7006, 7008-7011, 7014, 7015, 7017-7026, 7031, 7034-7036, 7039, 7041, 7043, 7045, 7047, 7049, 7050-7054, 7058, 7060, 7062, 7064, 7066, 7068, 7069, 7073-7075, 7077, 7080, 7081, 7084-7087, 7089, 7093-7099, 7104, 7106-7108, 7112, 7114, 7115, 7118, 7120-7123, 7125, 7128, 7129, 7131, 7133, 7135, 7137-7140, 7142, 7143, 7145, 7147, 7148, 7156, 7159, 7161, 7163, 7165, 7166, 7168, 7170, 7173, 7174, 7176, 7177, 7181, 7183-187, 7193-7200, 7205, 7208, 7210, 7211, 7215, 7216, 7220, 7223 & 7224;
  2. Serial #'s: 7007, 7012, 7013, 7016, 7027-7030, 7032, 7042, 7044, 7055, 7057, 7059, 7061, 7063, 7065, 7067, 7071, 7072, 7076, 7078, 7079, 7082, 7083, 7088, 7091, 7092, 7102, 7103, 7105, 7109, 7110, 7116, 7117, 7119, 7126, 7132, 7136, 7141, 7144, 7146, 7149, 7152-7154, 7158, 7160, 7164, 7167, 7169, 7171, 7172, 7175, 7178-7180, 7182, 7188-7190, 7192, 7201-7204, 7206, 7209, 7212-7214, 7217-7219 & 7221.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated December 5, 2011, Firm initiated recall is ongoing.
REASON
Philips received notification by a customer of an issue relating to unwanted auto delete occurrences resulting in raw data being deleted and, in some cases, raw data being deleted immediately after scan acquisition but before images are reconstructed.
VOLUME OF PRODUCT IN COMMERCE
197 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Multi-Analyte Urine DAU Calibrator (15 mL); Multi-Analyte,Intermediate Calibrator; for in-vitro diagnostic use only. Contains 300 ng/mL benzoylecgonine, 750 ng/mL d-methamphetamine, 4000 ng/m: morphine, 50 phencyclidine, 500 ng/m: oxazepam, 500 ng/mL secobarbital, 700ng/mL propoxyphene and 600 ng.mL methadone in urine buffer with dosium azide as preservitive. Drug abuse testing. Catalog 0804. Recall # Z-0847-2012
CODE
Lot number: 1101138K2, exp 1/28/2013
RECALLING FIRM/MANUFACTURER
Lin-Zhi International Inc., Sunnyvale, CA, by letter dated October 11, 2011, followed by a e-mail and telephone. Firm initiated recall is complete.
REASON
Catalog # 0804 Multi-Analyte Urine DAU Intermediate Calibrators were incorrectly labeled and mistakenly filled with Catalog # 0805 DAU High Calibrators.
VOLUME OF PRODUCT IN COMMERCE
49 items
DISTRIBUTION
Nationwide and Germany
PRODUCT
R2 Adult R2 Non-Radiolucent Multifunction Electrodes, Catalog/REF No. 3200-1715, NON-STERILE, MADE IN USA. This device, when connected to a monitor/defibrillator has the ability to monitor the electro-cardio function (ECG) of the patient. The device, when electrically activated by the monitor/defibrillator can pace the heart rate of the patient and may also transmit the electrical current to the patient for cardio-conversion. This is a non-sterile, disposable device. Recall #Z-0856-2012
CODE
Lot 1010194
RECALLING FIRM/MANUFACTURER
Recalling Firm: ConMed Corp., Utica,NY, by letter dated March 25, 2011.
Manufacturers: ConMed Corp., Utica,NY;
Consolidated Medical Equipment Co, Chihuahua, Mexico.
Firm initiated recall is complete.
REASON
The specific lot was assembled without the rivet cover.
VOLUME OF PRODUCT IN COMMERCE
850 sets (2 pads per set in individual pouch)
DISTRIBUTION
Nationwide, Canada, Belgium, Germany and Hong Kong
PRODUCT
5100-03-707 -- MOST Option STEM DISTRACTOR MATL: SS NONSTERILE QTY-1 Designed to facilitate intraoperative decisions with a variety of options for femoral and tibial components, implant connections and fixation of the implants. Recall # Z-0861-2012
CODE
Lots 1519123, 1616672, 1627174, 60281712, 60773654, 60795066, 60841064, 61061148, 61348637, and 61770544
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, by letter dated October 28, 2011. Firm initiated recall is ongoing.
REASON
Fractured tips: Any use of force in a certain direction to the flat side of the instrument may result in fracturing of the mating geometry, creating the potential for metal debris at the surgical site.
VOLUME OF PRODUCT IN COMMERCE
109 total
DISTRIBUTION
Nationwide and Switzerland
PRODUCT
Alaris PC unit model 8015. The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. Recall # Z-0876-2012
CODE
The affected units have unique serial numbers for traceability.
RECALLING FIRM/MANUFACTURER
CareFusion 303, Inc., San Diego, CA, by letter dated September 13, 2011. Firm initiated recall is complete.
REASON
The recall was initiated because Carefusion has identified a potential risk with a PLD component on the Alaris PC unit model 8015 power supply board. The PLD component used in production between June 21, 2011 and August 15, 2011 has a higher standby current resulting in the battery depleting prematurely.
VOLUME OF PRODUCT IN COMMERCE
1,039 units
DISTRIBUTION
Nationwide and Australia
PRODUCT
enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges, Catalog # enGen -- Common/Usual Name: enGen(TM) Track System, Hettich Centrifuge -- For in vitro diagnostic use only. The VITROS 5,1 FS Chemistry System with enGen(TM) Laboratory Automation System is intended 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). Recall # Z-0914-2012
CODE
All enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho-Clinical Diagnostics, Rochester, NY, by letter dated April 28, 2011.
Manufacturers: Ortho-Clinical Diagnostics, Rochester, NY;
Thermo Fisher Scientific OY, Vantaa, Finland;
Andreas Hettich Gmbh & Co. Kg, Tuttlingen, Germany.
Firm Initiated recall is ongoing.
REASON
Complaints of centrifuge buckets disconnecting from their supports during centrifugation when using the Hettich Rotanta 46 RSC Robotic Centrifuges, Models 4815, 4816 and 4817, that may be configured with enGen(TM) Laboratory Automation Systems.
VOLUME OF PRODUCT IN COMMERCE
78 units worldwide (18 Domestic and 68 Foreign)
DISTRIBUTION
Nationwide and Internationally
PRODUCT
The SIGMA HP Fixed Bearing Tibial Tray Impactor is part of a set of tools designed specifically for the installation of the PFC SIGMA Knee. SIGMA HP Fixed Bearing Tibial Tray Impactors Packaged in poly bag with optional protection from sharp or fragile points. Instruments are supplied non-sterile and do not have specified expiration date or shelf life. Usage: The Tibial Tray (with protective cover) and instrument are assembled outside of the patient in theatre; the tray is introduced and impacted into the cement containing tibia using the impactor. Once the tray is fully seated in the cement containing tibia, the instrument is intended to be removed. Catalog number 9505-01-306. Recall # Z-0930-2012
CODE
All lots: 071089, 071812, 071989, 072017, 072219, 072220, 072221, 072222, 080026, 080027, 080028, 080029, 080319, 080336, 080337, 080338, 080403, 080404, 080405, 080406, 080407, 080632, 080633, 080634, 080635, 080841, 080842, 080843, 080844, 080845, 080846, 080847, 080848, 080849, 081138, 082151, 082152, 082153, 082175, 082176, 082177, 082178, 082260, 082261, 082262, 082263, 082264, 082265, 082266, 082267, 082268, 082269, 083106, 083107, 083108, 083109, 083110, 083111, 083400, 083401, 083402, 083403, 083404, 083405, 083406, 083407, 083408, 083409, 083495, 090237, 090238, 090239, 090240, 090241, 090242, 090933, 090934, 090935, 090936, 090937, 090938, 090939, 090940, 090941, 090942, 094951, 094952, 100059, 100060, 100172, 100173, 100174, 100455, 100456, 100457, 100458, 100459, 100460, 100469, 100470, 100787, 102110, 102111, 102616, 102617, 102618, 102619, 102620, 102621, 102622, 102623, 102624, 104779, 104780, 105278, 105279, 110046, 110047, 110343, 110344, 110345, 110725, 110726, 110727, 110728, 110729, 111011, 111012, 111013, 112537, 112538, and 112539
RECALLING FIRM/MANUFACTURER
Recalling Firm: DePuy Orthopaedics, Inc., Warsaw, IN, by email dated December 13, 2011.
Manufacturer: Enztec Ltd, Christchurch, New Zealand. Firm initiated recall is ongoing.
REASON
The impactor can become intentionally locked on the Tibial Tray implant during surgery.
VOLUME OF PRODUCT IN COMMERCE
1794 (398 in USA)
DISTRIBUTION
Nationwide, Canada, Ireland and South Africa
PRODUCT
Product is a 15x16x27" (WxDxH) air purifier device with one of two different brands next to the control panel: HealthWay or CleanStation. HealthWay brand is sold under model number Deluxe 20600-3 Air Purification System. The CleanStation brand is sold under model number CS20000. The devices are intended to remove particles from the air for medical purposes. Recall # Z-0933-2012
CODE
Serial #’s: 08070001-08070425, 01080001-01080420, 13070001-13070415, 10080001-10080455, 33070001-33070458, 21080001-21080355, 34070001-34070455, 22080001-22080420, 35070001-35070455, 28080001-28080455, 36070001-36070455, 21080001-21080190, 38070001-38070395, 47080001-47080410, 39070001-39070455, 49080001-49080423, 45070001-45070195, 50080001-50080420, 42070001-42070455, 35090001-35090447, 43070001-43070455
RECALLING FIRM/MANUFACTURER
Recalling Firm: Healthway Home Products, Inc., Pulaski,NY, by letters on January 9, 2012.
Manufacturer: Shenzhen Healthway Elec Co. Ltd, Shenzhenshenzhen, China. Firm Initiated recall is ongoing.
REASON
A potential risk of electrical arcing that could cause overheating or fire within the units.
VOLUME OF PRODUCT IN COMMERCE
9,107 units
DISTRIBUTION
Nationwide and Canada
PRODUCT
Siemens MAGNETOM Aera/Skyra, model numbers 10432914 and 10432915. Nuclear magnetic resonance imaging system. Recall # Z-0940-2012
CODE
Serial numbers 45115, 41187, 41157, 41116, 45072, 45081, 41089, 41215, 41144, 41201, 45148, 41164, 41088, 41245, 41168, 41152, 45140, 45152, 45143, 45195, 41222, 41150, 45129, 45118, 45119, 41134, 41138, 45182, 45213, 41167, 41100, 52024, 45196, 45197, 41180, 41130, 45088, 41189, 41104, 41246, 41176, 45138, 15084, 41071, 45120, 45107, 41271, 45135, 45141, 41264, 45110, 41279, 41231, 41284, 41235, 45221, 45223, 41276, 41278, 41137, 41225, 41131, 41141, 41233, 45185, 41236, 41238, 45149, 41191, 45074, 45106, 45006, 45201, 41133, 41265, 41188, 45220, 41140, 41079, 45160, 45167, 41194, 45155, 45130, 41241, 41170, 45147, 41006, 45219, 45085, 45150, 45031, 41162, 45121, 45134, 45099, 45038, 45079, 41109, 41156, 45116, 41249, 45128, 45078, 45214, 41103, 45229, 41234, 45181, 52025, 52021, 45105, 45132, 41149, 45228, 45060, 45080, 45208, 41083, 45230, 45205, 41097, 41181, 45093, 45199, 45184, 45071, and 45111
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated November 24, 2010.
Manufacturer: Siemens AG, Medical Solutions, Business Unit XP. Erlangen, Germany. Firm initiated recall is ongoing.
REASON
During product monitoring firm has discovered that on a few systems the gradient cable connections did not meet their specifications after installation. Locally, the cable connections overheated, making servicing necessary. The potential existed for a cable connection to become overheated, leading to the emission of smoke and possible material damage.
VOLUME OF PRODUCT IN COMMERCE
128 units
DISTRIBUTION
Nationwide
PRODUCT
Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MLC, Reference/FSCA CP-05591, Model Number: H53. Intended use: The Varian Millennium 120 Collimator (MLC) is an x-ray collimator designed to be mounted on a C or EX Series Varian Clinac radiation therapy linear accelerator and is intended to shape the x-ray field perimeter. Field shape can either be static (fixed) or dynamic. Dynamic field shapes are controlled as a function of either Clinac dose fraction or gantry angle. The intended use is to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. Recall # Z-0945-2012
CODE
H530001, H530075, H530439, H533043, H535023, H535082, H535128, H535180, H535220, H530004, H530078, H531008, H534004, H535024, H535084, H535131, H535181, H535867, H530008, H530082, H531010, H534015, H535025, H535085, H535133, H535182, H536005, H530012, H530084, H531020, H534020, H535030, H535086, H535135, H535183, H536452, H530014, H530085, H531025, H534021, H535031, H535087, H535137, H535184, H536465, H530018, H530087, H531029, H534022, H535033, H535088, H535141, H535186, H536479, H530021, H530104, H531033, H534026, H535035, H535091, H535142, H535188, H530022, H530204, H531035, H534032, H535036, H535094, H535144, H535190, H530023, H530231, H531038, H534036, H535039, H535098, H535147, H535191, H530024, H530250, H531041, H534040, H535043, H535099, H535149, H535192, H530030, H530311, H531043, H534223, H535044, H535100, H535151, H535193, H530034, H530323, H531044, H535003, H535045, H535104, H535154, H535194, H530035, H530339, H532005, H535004, H535046, H535105, H535157, H535195, H530036, H530340, H532006, H535005, H535047, H535106, H535159, H535197, H530045, H530396, H532014, H535008, H535053, H535108, H535161, H535199, H530046, H530401, H532021, H535009, H535054, H535109, H535162, H535200, H530049, H530405, H532027, H535012, H535055, H535111, H535164, H535201, H530050, H530417, H533004, H535013, H535056, H535115, H535166, H535207, H530051, H530423, H533008, H535014, H535058, H535116, H535167, H535209, H530055, H530425, H533014, H535015, H535068, H535117, H535168, H535211, H530057, H530427, H533027, H535016, H535070, H535120, H535169, H535213, H530063, H530428, H533028, H535017, H535072, H535121, H535173, H535214, H530064, H530429, H533029, H535018, H535073, H535122, H535176, H535215, H530066, H530430, H533036, H535020, H535076, H535123, H535177, H535218, H530068, H530433, H533037, H535021, H535081, H535124, H535178, H535219
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated November 10, 2011. Firm initiated recall is ongoing.
REASON
Failure to retract or park the Varian MLC leaves prior to use of the demountable BrainLAB m3 could result in the Varian MLC leaves interfering with the treatment field defined by the BrainLAB m3 without an interlock being asserted.
VOLUME OF PRODUCT IN COMMERCE
205 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
VITROS Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name: VITROS Calibrator Kit 24. For in vitro diagnostics use only. VITROS Chemistry Products Calibrator Kit 24 is used to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of albumin in urine. Ortho-Clinical Diagnostics Inc. Recall # Z-0971-2012
CODE
Kit Lot 2430 (exp. 11/16/11, Kit Lot 2440 (exp. 01/08/12, Kit Lot 2450 (03/09/12, Kit Lot 2471 (exp. 7/14/12
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, by letter dated October 27, 2011. Firm initiated recall is ongoing.
REASON
Ortho Clinical Diagnostics received numerous complaints of lower than expected results for control fluids and patient samples upon initial calibration or following a recalibration using VITROS Chemistry Products Calibrator Kit 24 and VITROS Chemistry Products mALB Reagent.
VOLUME OF PRODUCT IN COMMERCE
4436 units worldwide (nationwide - 2201; internationally - 2235)
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Volcano pcFM Software Kit. The volcano pcFM Software Kit is a research only off line tool intended for review and printout of physiological measurements recorded by ComboMap System. It is not intended for analysis or manipulation of the original measurement data. Model 6830 ComboMap Software kit; Kit. Recall # Z-0973-2012
CODE
P/N #'s: 803259001; 806431005; S2000061; 806431002
RECALLING FIRM/MANUFACTURER
Volcano Corp., Rancho Cordova, CA, by letter dated June 17, 2010. Firm initiated recall is complete.
REASON
Internal review of validation of pcMF Software kit found that instructions directs user to remove the rear panel, causing the potential for electric shock.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
Nationwide, The Netherlands, Sweden and United Kingdom
PRODUCT
Custom surgical kits: DeRoyal(R) TRAUMA CRANIOTOMY PACK, REF 89-7639.01, STERILE EO, DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.01, STERILE EO, DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.02, STERILE EO, surgical kits Recall # Z-1003-2012
CODE
Lot Number 24579045 REF 89-7639.01 - Lot Number 24664258 REF 89-7639.02 - Lot Numbers: 24828048, 25598985, 25359212, 25399676
RECALLING FIRM/MANUFACTURER
DeRoyal Processing Center, New Tazewell, TN, by letter dated January 6, 2012 and by email on January 10, 2012. Firm initiated recall is ongoing.
REASON
The firm distributed surgical kits which contained DermaHook Neuro Elastic Retractors which were subsequently recalled by Teleflex.
VOLUME OF PRODUCT IN COMMERCE
214 units
DISTRIBUTION
Nationwide
PRODUCT
Surgical lighting systems iLED and TruLight in use with the ALC+ function. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light. Recall # Z-1010-2012
CODE
Material number 1583966
RECALLING FIRM/MANUFACTURER
Recalling Firm: Trumpf Medical Systems, Inc., Charleston, SC, by letter dated January 9, 2012.
Manufacturer: Kreuzer Gmbh & Co. KG, Puchheim, Germany. Firm initiated recall is ongoing
REASON
The ALC+ function may not be properly locked during use resulting in the possibility of the handle falling off into the surgical field causing injury to the patient.
VOLUME OF PRODUCT IN COMMERCE
8733 units (4709 US)
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS III
PRODUCT
New Label: EtchMaster ***Cordless Handpiece***P/N 797 HAZARD WARNING: Using CO2 cartridges from other suppliers may cause an operational hazard and will void the warrantee. Old Label: EtchMaster***Cordless Handpiece*** The Cordless Etcher air brush is powered by CO2 mini-cartridges to deliver pressurized gas to the EtchMaster pre-filled disposable micro air abrasive tips. The Cordless Etcher handpiece is quickly re-loaded with a CO2 mini-cartridge. Each CO2 mini-cartridge provides sufficient power to run 3 EtchMaster tips. The EtchMaster tips are used to abrade tooth surfaces and prosthetic devices prior to bonding procedures. Recall # Z-0742-2012
CODE
GRO-SK-EM-CE-R-RB-Sk GRO-SK-EM-CE-K-RB-SK GRO-SK-EM-CE-K-CA-SK ROPI-EM
RECALLING FIRM/MANUFACTURER
Groman Inc., Margate, FL, by letter dated March 1, 2011. Firm initiated recall is ongoing.
REASON
When non-conforming cartridges are inserted into the Cordless Etcher they can induce excessive stresses on the device causing cracks in the plastic housing of the device. These crack can lead to a hazardous situation due to the high pressure of the gas contained in the CO2 cartridges.
VOLUME OF PRODUCT IN COMMERCE
395 devices
DISTRIBUTION
Nationwide, and Netherlands
PRODUCT
Imalux Niris OCT Imaging System Probe, Model Number 1300. The Niris Imaging System probe is used with the Niris Imaging System. The Niris Imaging System employs Optical Coherence Tomography (OCT), which can be used to construct high spatial resolution. The probe, is attached to the Imaging Console, and is used to direct light to and from the patient tissue. A small electromechanical scanning mechanism in the probe moves the optical beam laterally across the tissue surface while simultaneously acquiring in-depth backscattering profile at each lateral position. The probe is not labeled or sold as sterile. Recall # Z-0934-2012
CODE
Serial Number F464019
RECALLING FIRM/MANUFACTURER
Imalux Corp., Cleveland, OH, by telephone on December 14, 2011. Firm initiated recall is ongoing.
REASON
During an FDA inspection, the firm was notified that the wrong tubing was used during the manufacture of the probe for the unit.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
PRODUCT
Integra PAC1 Mod 2 Cables used with the Integra MPM, CAM01 Monitors. MPM, CAMO1, PAC1. Recall # Z-0944-2012
CODE
MEF1100103; MED1102303; MEB1101602; MEF1100203; MEC1100602; MED1101003; MED1102203; MEE1102003; MED1102103; MEC1102302; MEB1101402; MEE1101003; MEF1100703; MEE1101903; MEF1101103; MEB1100803; MEC1103002; MEE1100903; MED1101703; MED1101203; MEC1102902; MEB1101103; MEC1102002; MEB1101502; MED1102203; MEF1100603; MEE1101203; MEC1100102; MEE1101503; MEE1100703; MEF1100403; MED1101303; MED1101403; MEF1100303; MEC1100702; MED1101103; MEC1102402; MEC1101602; MEF1100903; MEE1101303; MED1102003; MEC1103302; MEE1101803; MEE1100803; MEF1100503; MEC1102502; MEC1101702; MEE1101403; MEC1103402; MEF1100803; MEC1102802; MEC1101802; MEF1101003; MEC1103102; MEC1101902; MEC1102102
RECALLING FIRM/MANUFACTURER
Integra LifeSciences Corp., Plainsboro, NJ, by letter dated October 20, 2011. Firm Initiated recall is ongoing.
REASON
Some of the connector cables associated with Integra's intracerebral pressure (ICP) monitors may cause temporary interference with the ICP waveform on the monitor display.
VOLUME OF PRODUCT IN COMMERCE
221 units
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS I
PRODUCT
  1. No. 60440 V.0310 Owen Bean Far-Off Dry Cow Mineral FEED TO NON-LACTATING DAIRY COWS INGREDIENTS Processed Grain By-Products, Grain Products, Roughage Products, Plant Protein Products, Molasses Products, Dicalcium Phosphate, Calcium Sulfate, Magnesium Oxide, Calcium Carbonate, Magnesium Sulfate, Cobalt Carbonate, Copper Sulfate, Ethylenediamine Dihydriodide, Manganese Sulfate, Manganous Oxide, Zinc Sulfate, Cobalt Sulfate, Zinc Oxide, Vitamin A Supplement, Vitamin D3 Supplement, Vitamin E Supplement, Sodium Selenite, Vegetable Oil, Zinc Methionine Complex, Manganese Methionine Complex, Copper Lysine Complex, Cobalt Glucoheptonate, Copper Amino Acid Chelate, Manganese Amino Acid Chelate, Zinc Amino Acid Chelate, Natural and Artificial Flavors, Vitamin D Supplement. Recall # V-033-2012;
  2. Hi-Pro Feeds No. 60255 V.0210 Owen Bean Heifer Mix MEDICATED For dairy replacement heifers ACTIVE DRUG INGREDIENT Lasalocid 68 g/ton INGREDIENTS Grain Products, Roughage Products, Processed Grain By-Products, Plant Protein Products, Molasses Products, Calcium Carbonate, Salt, Zinc Sulfate, Manganese Sulfate, Vitamin E supplement, Zinc Methionine Complex, Manganese Methionine Complex, Copper Lysine Complex, Cobalt Glucoheptonate, Copper Sulfate, Copper Amino Acid Chelate, Manganese Amino Acid Chelate, Zinc Amino Acid Chelate, Sodium Selenite, Vegetable Oil, Vitamin A Supplement, Vitamin D Supplement, Ethylenediamine Dihydriodide, Cobalt Carbonate. Recall # V-034-2012;
  3. Hi-Pro Feeds No. 60327 V.0310 HOLY COW CALF RATION MEDICATED For dairy replacement heifers. Control of coccidiosis caused by Eimeria bovis and Eimeria zuernii in replacement calves. ACTIVE DRUG INGREDIENT Lasalocid 68 g/ton INGREDIENTS Grain Products, Plant Protein Products, Roughage Products, Molasses Products, Fat Products (Feed Grade), High Fructose Corn Syrup, Proylene Glycol, Polysorbate 60, Glycerin, Sulfuric Acid, Xanthan Gum, Ethoxyquin (a preservative), Calcium Carbonate, Salt, Dicalcium Phosphate, Magnesium Oxide, Manganese Sulfate, Zinc Sulfate, Manganous Oxide, Zinc Oxide, Manganese Amino Acid Complex, Copper Sulfate, Copper Amino Acid Complex, Cobalt Glucoheptonate, Mineral Oil, Sodium Selenite, Choline Chloride, Calcium Iodate, Niacin Supplement, Thiamin Mononitrate, Zinc Amino Acid Complex, Cobalt Carbonate, Cobalt Sulfate, D-Calcium Pantothenate, and Ethylenediamine Dihydriodide, Vitamin E supplement, Vitamin A Supplement, Vegetable Oil, Vitamin D Supplement. Recall # V-035-2012
CODE
  1. Lot: 4-0803-1001;
  2. Lot: 4-0803-1002;
  3. Lot: 4-0802-1014
RECALLING FIRM/MANUFACTURER
Unifeed Hi-Pro, Inc., Comanche, TX, by telephone. Firm initiated recall is complete.
REASON
The feed has the potential to contain elevated levels of urea.
VOLUME OF PRODUCT IN COMMERCE
18,800 pounds
DISTRIBUTION
TX
 
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS II
PRODUCT
Levothyroxine sodium tablets, USP, 0.4 mg., RX, packaged under the following product names and package sizes:
  1. LLOYD Thyro-Tabs, packaged in 120-tablet bottles, NDC 11789-254-10;
  2. VET A MIX Thyro-Tabs, packaged in 1,000-tablet bottles, NDC 11789-254-20;
  3. VEDCO Thyrosyn .4 mg Tablets, packaged in 180-tablet bottles, (NDC 50989-284-86) and 1,000-tablet bottles, (NDC 50989-284-53);
  4. BUTLER SCHEIN ANIMAL HEALTH Thyroxine L, packaged in 1,000-tablet bottles, NDC 11695-4464-2; and
  5. PHOENIX Thyrozine 0.4 mg, packaged in 1,000-tablet bottles, NDC 57319-334-16. Recall # V-031-2012
CODE
Lot # KB01911, Exp date 4/12
RECALLING FIRM/MANUFACTURER
Lloyd Inc., Shenandoah, IA, by letters dated October 27, 2011 and November 8, 2011. Firm initiated recall is ongoing.
REASON
The recalled product may not maintain potency throughout its labeled shelf-life.
VOLUME OF PRODUCT IN COMMERCE
Thyro-Tabs: 1,614/120-tab. bottles and 432/1,000-tab. bottles; Private label: 718/180-tab. bottles and 997/1,000-tab. bottles
DISTRIBUTION
Nationwide and Israel
 
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS III
PRODUCT
Pfizer Strongid* T pyrantel pamoate oral suspension USP, containing 50 mg/mL Pyrantel (as pyrantel pamoate), Veterinary Use Only, caramel flavored anthelmintic for horses, packaged in 600-mL bottles, for oral administration, OTC, DIN 00288616. Recall # V-032-2012
CODE
Lot #2027973, exp. date 09/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Canada Inc. - Kirkland, QC Administrative Site, Kirkland, Canada, by fax or e-mail on November 28, 2011.
Manufacturer: Pfizer Inc Pfizer Global Mfg, Lincoln,NB. Firm initiated recall is ongoing.
REASON
Out of specification for particle size.
VOLUME OF PRODUCT IN COMMERCE
1,603/600-mL containers
DISTRIBUTION
Canada
 
END OF ENFORCEMENT REPORT FOR FEBRUARY 15, 2012.
 
#

Page Last Updated: 08/25/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.