Safety
FDA Enforcement Report for April 4, 2007
WWWweekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
April 4, 2007
07-14
RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS I
___________________________________
PRODUCT
Kellogg brand Pop-tarts, Frosted Blueberry, 14.7 ounce carton of 8; UPC 3800031010, Recall # F-165-7
CODE
Best if used before AUG27 07 CPC3
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kellogg USA Inc, Battle Creek, MI, by press release on December 14, 2006.
Manufacturer: Kellogg Co, Muncy, PA. Firm initiated recall is complete.
REASON
Some Blueberry Pop-Tart cartons contain another product, Hot Fudge Sundae Pop-Tarts. The Hot Fudge Sundae Pop-Tarts contain milk, while the label of the Blueberry Pop-Tarts does not list milk as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
35,520 cartons
DISTRIBUTION
Nationwide
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PRODUCT
KEFENG BEWTICH DRIED PINEAPPLE, NET WT: 90g. Ingredients: Orange Peel, Hawkthorn, Lemon, Greengage, Honey Essence, Citric acid, Saccharin --- Standard No.:Q/QXRF01-2000; Standard Record Code: QB/445221 67 248 --- --- Exp.: 18 months; Pro. Date: At the seal. --- UPC barcode - 6 926544 984887 --- Please note that product label is also in Chinese language. Product is packaged in a plastic bag, Recall # F-166-7
CODE
Illegible coding
RECALLING FIRM/MANUFACTURER
Recalling Firm: Korica International Inc. Brooklyn, NY, by Consumer Alert on November 2, 2006 and by letter on November 4, 2006.
Manufacturer: Jie Dong Qu Xi Rui Feng Honeg Fruits Factory; Add: Green Industry Garden Jiedong Guangdong (One of the Ten Famous development areas), China. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (771.6 ppm) based on sampling & analysis by New York State Department of Agriculture & Markets. The product also contains undeclared tartrazine, certifiable as FD&C Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
Unable to be determined
DISTRIBUTION
DC, FL, IL, MA, NY, PA, and VA
___________________________________
PRODUCT
Krisp-Pak brand Fresh Fruit, containing cut mixed fruit packaged in 4 ounce, 8 ounce and 1 pound clear plastic cups, 3 pound tubs and 2½ pound, 4½ pound and 5 pound trays. Four ounce cups are labeled in part ***may contain cantaloupe, honeydew & red grapes***. Cups, tubs and trays are labeled in part ***may contain honeydew, watermelon, cantaloupe, pineapple, strawberries and seedless grapes*** and further labeled in part ***Krisp-Pak brand, Recall # F-167-7
CODE
All codes with expiration before 11/30/06.
RECALLING FIRM/MANUFACTURER
Krisp-Pak Company Inc., Norfolk, VA, by telephone and fax on October 31, 2006 and by press release on November 1, 2006. Firm initiated recall is complete.
REASON
Packages of fresh cut fruit products may be contaminated with the bacterium, 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.
VOLUME OF PRODUCT IN COMMERCE
1,001 cases
DISTRIBUTION
VA and NC
RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS II
___________________________________
PRODUCT
Chocolate Cream Truffles, Elegant Sweets brand, in 3 different types/sizes of packaging, Elegant Gourmet, Woodinville, WA. Packaging includes: a round, brown and beige box, tied with a brown ribbon, net wt. 8.8-oz (246 grams) case code ESTRUF; a pink and white box tied with a pink ribbon, net wt. 3-oz (85 g) case code VPBOX07 and is part of the Valentine''s Day Collection in the catalog; third style/size is a red velvet heart shaped box with a red ribbon and white roses tied on top, net wt. 4.5-oz (128 g) case code ZFAOVBOX, Recall # F-136-7
CODE
Individual containers are not coded. All packages are subject to recall. ESTRUF - Case code for round, brown and beige box, tied with a brown ribbon. VPBOX07 - case code for pink and white box tied with a pink ribbon, part of the Valentine's Day Collection in the catalog. ZFAOVBOX - case code for the red velvet heart shaped box with a red ribbon and white roses tied on top.
RECALLING FIRM/MANUFACTURER
Elegant Gourmet, Inc., Woodinville, WA., by press release on January 22, 2007, by telephone beginning on January 23, 2007, and by letters on January 23/24, 2007. Firm initiated recall is complete.
REASON
Product contained ingredient (whey) derived from milk, but label did not identify the ingredient source as required.
VOLUME OF PRODUCT IN COMMERCE
4,622 boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Baby Basics by Albertson's Pop-Ups; 160 count; UPC #41163 25036
(unscented) and #41163 25035 (scented), Recall # F-137-7;
b) Baby Wipes (Dollar General); 80 and 240 counts; UPC #71287 85966 (80 ct.)
and #41163 85967 (240 ct.); distributed by Dolgencorp, Inc. (Dollar General),
Recall F-138-7;
c) Food Lion Baby Wipes; 400 count; UPC #35826 06288, Recall # 139-7;
d) Hannaford Pop-Ups Baby Wipes; 80 and 160 counts; UPC #41268 12183
(80 ct. unscented), #41268 12185 (80 ct. scented), #41268 13280
(160 ct. unscented) and #41268 13279 (160 ct. scented), Recall # F-140-7;
e) H-E-B baby; 240 ct.; UPC #41220 16806 (unscented) and #41220 16805
(scented), Recall # F-141-7;
f) American Fare Clean Cloths; 80 ct.; UPC #72000 117140; and Little Ones
Premium Wipes, 400 ct., UPC #72000 14537; made for Kmart Corporation,
Recall # F-142-7;
g) Kroger Comforts Baby Wipes; 160 and 400 ct.; UPC #11110 36170
(160 ct. unscented), #11110 36169 (160 ct. scented), #41260 33452 (400 ct.
unscented) and #41260 33451 (400 ct. scented), Recall # F-143-7;
h) Long's Baby Wipes; 160 Count.; UPC #12333 (unscented) and #41163 25035
(scented), Recall # F-144-7;
i) Meijer Drybabies; 240 and 400 counts; UPC #19283 51472 (240 ct. unscented)
and #19283 51474 (400 ct. scented), Recall # F-145-7;
j) Publix Premium Baby Wipes; 80, 160 and 320 counts; UPC #41415 04467
(80 ct. unscented), #41415 05667 (80 ct. scented), #41415 08167
(160 ct. unscented), #41415 08067 (160 ct. scented), #41415 08267
(320 ct. unscented) and #41415 08367 (320 ct. scented), Recall # F-146-7;
k) Pure'nGentle Baby Wipes; 160 ct.; UPC #71287 85646 (unscented)
and #71287 85631 (scented); manufactured by Rockline Industries,
Recall # F-147-7;
l) Member's Mark Moist Wipes Pop-Ups; 740 count; UPC #81131 90060,
Recall # F-148-7;
m) Stater Bros. Baby Wipes; 80 Count; UPC #74175 04955, Recall # F-149-7;
n) Equate Pop-Ups; 80 and 160 counts; UPC #71287 85975 (80 count tub),
#71287 85978 (80 count refill); #71287 85641 (160 count bag),
Recall # F-150-7;
o) Parent's Choice Premium Baby Wipes; 240 and 400 counts;
UPC #71287 85823 (240 count), #71287 858778 (400 count);
imported for Wal-Mart Canada Corp., Recall # F-151-7;
p) Wegman's Baby Wipes; 80 and 240 counts; UPC #77890 63623
(80 count unscented), #77890 31414 (240 count scented), Recall # F-152-7;
q) Western Family CozyCare; 160 count; UPC #15400 07263, Recall # F-153-7;
r) Teddy;s Choice Soft Touch Quilted Baby Wipes; 240 count;
UPC #60383 74456 (unscented) and #60383 74457 (scented),
Recall # F-154-7;
s) Option+ Supreme Baby Wipes; 80 count; UPC #71290 00226,
Recall # F-155-7;
t) Simply Kids Baby Wipes; 160 count; UPC #82795 00030 (unscented)
and #82795 00029, Recall # F-156-7;
u) Safeway Pop-Ups; 80, 160 and 400 counts; UPC #58200 79259
(80 ct. unscented), #58200 79240 (160 ct. scented) and #58200 79224
(400 ct. unscented), Recall # F-157-7
CODE
All codes from 06233 to 06253 (Julian dates corresponding to product produced Aug 21, 2006 to Sept. 10, 2006).
RECALLING FIRM/MANUFACTURER
Rockline Industries, Springdale, AR, by press release, telephone and letters on November 17, 2006. Firm initiated recall is ongoing.
REASON
The product may be contaminated with Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
194,924 units
DISTRIBUTION
Nationwide and Canada
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PRODUCT
a) Earth's Best Organic 2 Wholesome Breakfast Apple Peach Barley.
The product is sold in a 4.5 oz glass jars. The individual jars have a
UPC code 23923-20220, Recall # F-159-7;
b) Earth's Best Wholesome Breakfast Variety Pack. This variety pack
contains 12 jars of baby food, four of which are 4.5 oz glass jars of the
Apple Peach Barley. The UPC code on the variety pack is 23923-20295,
Recall # F-160-7
CODE
a) PF6J14 NP (with an additional 4 numbers representing time)
EXP 14 SEP 08 A;
b) The Apple Peach Barley jars within the variety pack are coded PF6J14 NP
(with an additional 4 numbers representing time) EXP 14 SEP 08 A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hain Celestial Group, Inc., Melville, NY, by letter on February 9, 2007 and by press release on February 16, 2007.
Manufacturer: Bay Valley Foods, LLC, Pittsburgh, PA. Firm initiated recall is ongoing.
REASON
ph of baby food product is not adequate to control for growth and toxin formation by Clostridium botulinum.
VOLUME OF PRODUCT IN COMMERCE
250,920 jars
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
365™ Everyday Value Kalamata Olive Tapenade, 8.12 oz. UPC Code 99482-41757, Recall # F-161-7
CODE
Lot # BB 14/09/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Whole Foods Market, Austin, TX, by email and telephone and press release on January 31, 2007 and by email and telephone on February 1, 2007.
Manufacturer: Intercomm Foods S.A., Larissa, Greece. Firm initiated recall is complete.
REASON
Product may contain glass fragments.
VOLUME OF PRODUCT IN COMMERCE
32,551 jars
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Little Debbie snacks, Nutty Bars, wafers with peanut butter, 2 bars per individual package. Packaging: Big Pack, 12 twin packs, 24 bars, 12 twin packs, net wt. 25.2 oz. (1lb 9.2 oz) 714g; 12 bars, twin wrapped, net wt. 12 oz. (340 g); and net wt 3 oz (85g) - vending machine pack, Recall # F-162-7
CODE
Multi-pack carton, 12 oz package: Mar 31 07, 01302091; April 01 07, 01302093; April 01 07, 01312091; April 01 07, 01312092; April 02 07, 02012091; and April 02 07, 02012092 Multi-pack carton, 25.2 oz package: Mar 31 07, 01302101; Mar 31 07, 01302102; and Apr 01 07, 01302103 Vend pack: April 01 07, 01312101
RECALLING FIRM/MANUFACTURER
McKee Foods Corporation, Collegedale, TN, by telephone on February 2, 2007. Firm initiated recall is complete.
REASON
Product was manufactured with peanut paste component that was found to contain metal particles.
VOLUME OF PRODUCT IN COMMERCE
2,661 cases
DISTRIBUTION
NC, VA, GA, MD, OH, and IL
___________________________________
PRODUCT
Peanut Paste in unlabeled bulk tankers, Recall # F-163-7
CODE
Tanker #101 (01/29/2007 and 01/31/2007), Tanker #102 (delivered 02/01/2007) Tanker #103 (01/30/2007), Tanker #104 (01/30/2007) Tanker #106 (02/01/2007 and 02/02/2007)
RECALLING FIRM/MANUFACTURER
Peanut Processors, Inc., Dublin, NC, by telephone on February 6, 2007. Firm initiated recall is ongoing.
REASON
Product may contain metal fragments.
VOLUME OF PRODUCT IN COMMERCE
7 tankers (322,000 lbs)
DISTRIBUTION
NC, TN, and VA
RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS III
___________________________________
PRODUCT
Glacier Valley brand Spring Water, Item #41554, and Le Alpi brand Spring Water, Item #41555, packed in 3 oz. plastic cups with foil lids. 120 cups per case, Recall # F-164-7
CODE
Glacier Valley brand Spring Water and Le Alpi brand Spring Water are identified with the Lot Code: E0077 A1 printed on outer case, and the Expiration Date: 01/06/09. An additional lot code of Glacier Valley brand Spring Water identified with the Lot #E-0567 B2 printed on the outer case has also been recalled by this firm. This product has the labeled Expiration Date: 02/24/09.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Country Pure Foods Inc., Akron, OH, by letters on February 23, 2007 and March 15, 2007.
Manufacturer: Country Pure Foods, Inc., Ellington, CT. Firm initiated recall is ongoing.
REASON
Laboratory analysis indicate bromate levels in excess of Federal limit of 10 ppb.
VOLUME OF PRODUCT IN COMMERCE
1,829 cases x 120 cups per case
DISTRIBUTION
NJ, NY, IL, and GA
___________________________________
PRODUCT
Pedia Sure with Fiber and FOS, enteral formula, Vanilla Flavor, Recall # F-168-7
CODE
49304RE, use by 1Feb2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ross Products Division Abbott Laboratories, Columbus, OH., by letter dated January 23, 2007 and by visit on January 24, 2007.
Manufacturer: Ross Products Division Abbott Laboratories, Casa Grande, AZ. Firm initiated recall is ongoing.
REASON
PediaSure with Fiber and FOS, Enteral Formula does not meet label claim for micronutrients – choline and 1-carnitine.
VOLUME OF PRODUCT IN COMMERCE
289 cases/24/8 oz metal cans per case
DISTRIBUTION
AZ and CA
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
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PRODUCT
Cardioplegia infusion solutions including the following product names: Cold Induction, Cardiac Reperfusate, Physiologic K Warm Induction, Low K Maintenance, Warm Induction, High K Cold Induction, Regular Maintenance, Enriched Reperfusate, Regular Induction, Cardioplegic Solution Bag #1, Cardioplegic Solution Bag #2, Cardioplegic Solution Bag #3, Cardioplegic Solution Bag #4, Cardioplegic Solution Bag #5, Cardioplegia Solution ''A'', Cardioplegia Solution ''B'', Cardioplegic Solution ''C'', Multidose Cardioplegia, Cardioplegia Bag #1, Cardioplegia Bag #2, Cardioplegia Bag #3, Hot Shot Cardioplegia, Dr. Johnson Low K Formula, Dr. Johnson High K Formula, Bag #1, Bag #2, Modified Buckberg Cold Induction, Modified Buckberg Maintenance, Modified Buckberg Reperfusion, Cardio Base #2, Fairfax REPF, Fairfax BASE, Cardio Enriched Solution, Cardio Base #1, Theodoro Cardioplegia Solution, Warm Induction, Multidose VC Standard, Induction and Reperfusion Formulation, AAECS Bag #1, NONAAECS Comp. Soln., Hot Shot, Maintenance, Reperfusion, Maintenance Multidose Cardioplegia, Cardioplegia Solution ''D'', Induction Formula, Maintenance Formula, Enriched Induction Cardioplegia, Buckberg Cardioplegia V, Buckberg Cardioplegia VI, Reperusate ''Hot Shot'' Cardioplegia, Cardiolegia Low K, Cardioplegia High K, Low Potassium Cardioplegia, High Potassium Cardioplegia, Cardio Base One (1) High K, Cardio Base Two (2) Low K, Enriched Cardioplegia Solution, Maintenance Cardioplegia, Induction Cardioplegia, Union Memorial Cold Induction, Union Memorial Maintenance. Products are manufactured to order and packaged in clear plastic infusion bags in various volumes, and labeled in part '***Prep by: Central Admixture Pharmacy services, Inc. Birmingham***'. The product is labeled with the names (as listed above), the component formula and the specified consignee, Recall # D-485-2007
CODE
None. Sold by prescription only.
RECALLING FIRM/MANUFACTURER
Central Admixture Pharmacy Services Inc., Homewood, AL, by telephone November 6, 2006 and by letter on November 9, 2006. Firm initiated recall is ongoing.
REASON
Mislabeled; Cardiac infusion drug may contain 5% Dextrose in water instead of Citrate Phosphate Dextrose.
VOLUME OF PRODUCT IN COMMERCE
1,791 bags
DISTRIBUTION
AL, FL, TN, LA, VA, MS, KS, MO. MD, GA, and D.C
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0911-07
CODE
Unit: KZ84475
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI., by facsimile on June 30, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0933-07
CODE
Units: N14142 (2 units), N17323 (2 units)
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI., by facsimile on November 6, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a ineligible donor due to recent ingestion of aspirin-like medication, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MI
___________________________________
PRODUCT
Source Plasma, Recall # B-0934-07
CODE
Units: RZ023924, RZ023680, RZ023509, RZ023255, RZ022814, RZ022609, RZ022153, RZ022018, RZ021792, RZ021521, RZ021060, RZ020734, RZ020618, RZ020291, RZ020067, RZ019800, RZ019617, RZ019358, RZ019142, RZ018891, RZ018582, RZ018053, RZ017731, RZ017517, RZ017274, RZ017177, RZ014267, 06HINA5854, 06HINA0286, 05HINB1441, 05HINB1363, 05HINB1140, RP068622, 05HINB0836, 05HINB0712, 05HINB0661, 05HINB0544, 05HINB0390, 05HINB0322, 05HINB0139, 05HINB0074, 05HINA9951, 05HINA9898, 05HINA9770, 05HINA9699, 05HINA9549, 05HINA9517, 05HINA9278
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Hammond, IN., by facsimile on September 22, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for a history of incarceration, were distributed..
VOLUME OF PRODUCT IN COMMERCE
48 units
DISTRIBUTION
CA and Austria
___________________________________
PRODUCT
Source Plasma, Recall # B-0957-07
CODE
Units: 0141246076, 0141245446, 0141244940, 0141244696, 0141239892, 0141239691, 0141238717, 0141238429, 0141238021, 0141237723, 0141237414, 0141237100, 0141228457, 0141228149, 0141227190, 0141226919, 0141226364, 0141225917, 0141225428, 0141225009, 0141224577, 0141223989, 0141223722, 0141223283, 0141223024, 0141221311, 0141221090, 0141220604, 0141219199, 0141218328, 0141217649, 0141217445, 0141216033, 0141215545, 0141215185, 0141214266, 0141212763, 0141212475, 0141211840, 0141211058, 0141234323, 0141234085, 0141233665, 0141233393, 0141232129, 0141231590, 0141231059, 0141230663, 0141230286, 0141229303, 0141229085
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Tulsa, OK, by facsimile on June 23, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for providing a history of multiple high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
51 units
DISTRIBUTION
NC and Switzerland
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0958-07
CODE
Unit: LW13774
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on December 3, 2006. Firm initiated recall is complete.
REASON
Blood product, which was labeled leukoreduced, but had an unacceptable white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0961-07
CODE
Units: FQ52843, FQ49705 (split unit), LH64272 (split unit)
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on September 23, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to recent ingestion of aspirin-like medication, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
WI
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0962-07;
b) Platelets, Recall # B-0963-07;
c) Fresh Frozen Plasma, Recall # B-0964-07
CODE
a), b) and c) Unit: W99131
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Traverse City, MI., by facsimile on January 4, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who lived in an area with increased risk for human immunodeficiency virus (HIV) Group O, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MI and NJ
___________________________________
PRODUCT
Platelets, Recall # B-0965-07
CODE
Unit: N58029
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on January 26, 2007. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Source Plasma, Recall $ B-0966-07
CODE
Units: 06MMIC3700, 06MMIC6136, 06MMIC6489, 06MMIC8192, 06MMIC8603, 06MMIC9092, 06MMIC9567, 06MMID0061, 06MMID0625, 06MMID1502, 06MMID2154, 06MMID2575, 06MMID3230, 06MMID3626, 06MMID4227, 06MMID4671
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Marquette, MI, by facsimile on September 29, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom post donation information was received regarding multiple high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma, Recall # B-0968-07
CODE
Unit: 377011963
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, dba Talecris Plasma Resources, Inc., Anderson, IN, by facsimile on June 6, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0969-07;
b) Platelets, Recall # B-0970-07;
c) Red Blood Cells, Leukocytes Reduced, Recall # B-0971-07;
d) Fresh Frozen Plasma, Recall # B-0972-07
CODE
a) and b) Unit: LC19668;
c) Units: LC23135, LC25849, LC28828, LC31607;
d) Units: LC23135, LC31607
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI., by facsimile on June 4, 2003. Firm initiated recall is complete.
REASON
Blood products, which tested negative for syphilis, but were collected from a donor who previously tested reactive for syphilis, were distributed
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
IL and WI
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0973-07
CODE
Unit: Y69657
RECALLING FIRM/MANUFACTURER
Central Pennsylvania Blood Bank, Hummelstown, PA, by facsimile on January 23, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0975-07;
b) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0976-07;
c) Platelets Pheresis, Leukocytes Reduced, Recall # B-0977-07;
d) Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0978-07;
CODE
a) Unit: 9010136;
b) Unit: 6962056;
c) Units: 6962066 (Parts 1 & 2), 6962076 (Parts 1 & 2), 9006601, 9006603 (Parts 1, 2, & 3),
9006606 (Parts 1 & 2), 9006615 (Parts 1 & 2), 9006627, 9006641, 9006650 (Parts 1 & 2),
9006654 (Parts 1 & 2), 9006657, 9006661 (Part 1), 9006665 (Parts 1 & 2),
9006683 (Parts 1, 2, & 3), 9010112, 9010123 (Parts 1 & 2), 9010131, 9010142, 9010149,
9010152 (Parts 1 & 2), 9021538 (Parts 1 & 2), 9021540, 9021554 (Parts 1 & 2),
9021573 (Part 1), 9100574 (Parts 1 & 2), 9100588;
d) Units: 9021551, 9021557, 9100548 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on December 30, 2004. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for Cytomegalovirus (CMV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
48 units
DISTRIBUTION
CO, MN, NB, NC, and UT
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
****CORRECTION****
In the March 14, 2007 (07-11) Enforcement Report, the correct PRODUCT is Red Blood Cells Irradiated, not Red Blood Cells.
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0347-07
CODE
Unit: 2801732
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on December 26, 2006 and by follow-up letter dated February 12, 2007. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Propionibacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT
Platelets, Recall # B-0348-07
CODE
Unit: E25475
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on February 2, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
a) Red Blood Cells, Leukocyte Reduced, Recall # B-0792-07;
b) Platelets, Recall # B-0793-07
CODE
a) Units: Y16164, Y16165, Y16167, Y16168, Y16169, Y16175, Y16177,
Y16180, Y16182;
b) Y16164, Y16165, Y16167, Y16168, Y16169, Y16173, Y16175, Y16177, Y16179
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN., by fax on October 6, 2005. Firm initiated recall is complete.
REASON
Blood products, manufactured from Whole Blood that lacked the assurance of storage at the correct temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
PA, GA, and TN
___________________________________
PRODUCT
Red Blood Cells, Leukocyte Reduced, Recall # B-0932-07
CODE
Unit: N54101
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on November 14, 2006. Firm initiated recall is complete.
REASON
Blood product, for which there was no documentation for the time period out of controlled storage, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells, Leukocyte Reduced, Recall # B-0935-07
CODE
Unit: LC35994
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by telephone on June 2, 2003. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Source Plasma, Recall # B-0960-07
CODE
Units: 364000019, 364004508, 364005337, 364007333
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, dba Talecris Plasma Resources, Inc., Fort Worth, TX, by facsimile on November 24, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells, Leukocyte Reduced, Recall # B-0974-07
CODE
Unit: Y79483
RECALLING FIRM/MANUFACTURER
Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by letter dated May 19, 2003. Firm initiated recall is complete.
REASON
Blood product, for which there was no documentation for the time period out of controlled storage, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
___________________________________
PRODUCT
a) RF Denervation Probe, 5cm, temperature sensing electrodes designed for
use in radiofrequency lesion procedures for the treatment of pain.
Part Number: 7210270, Recall # Z-0662-2007;
b) RF Denervation Probe, 10 cm, temperature sensing electrodes designed
for use in radiofrequency lesion procedures for the treatment of pain.
Product Number: 7210271, Recall # Z-0663-2007;
c) RF Denervation Probe, 15 cm, temperature sensing electrodes designed
for use in radiofrequency lesion procedures for the treatment of pain.
Product Number: 7210272, Recall # Z-0664-2007
CODE
a) Lot Numbers: 602549,602550, 602846, 602847;
b) Lot Numbers: 602541, 602542, 602556, 602557, 602558, 602559,
602560, 602561, 602562, 602848, 602849, 602999;
c) Lot Numbers: 602543, 602570, 602571, 602850, 603000
RECALLING FIRM/MANUFACTURER
Smith & Nephew, Inc., Endoscopy Div., Andover, MA., by letter on January 19, 2007. Firm initiated recall is ongoing.
REASON
Product is non-sterile but labeled incorrectly as sterile.
VOLUME OF PRODUCT IN COMMERCE
497 units
DISTRIBUTION
Nationwide and Internationally
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
___________________________________
PRODUCT
a) NexGen Complete Knee Solution Minimally Invasive Solutions
MIS Technology Femoral Finishing Guide, instrumentation used
in total knee arthroplasty procedures. Catalog No. 82015272518,
Recall # Z-0647-2007;
b) NexGen Complete Knee Solution Minimally Invasive Solutions
MIS Technology Femoral Finishing Guide, instrumentation used
in total knee arthroplasty procedures. Catalog No. 82015272519,
Recall # Z-0648-2007;
c) NexGen Complete Knee Solution Minimally Invasive Solutions
MIS Technology Femoral Finishing Guide, instrumentation used
in total knee arthroplasty procedures. Catalog No. 82015272520,
Recall # Z-0649-2007;
d) NexGen Complete Knee Solution Minimally Invasive Solutions
MIS Technology Femoral Finishing Guide, instrumentation used
in total knee arthroplasty procedures. Catalog No. 82015272521,
Recall # Z-0650-2007;
e) NexGen Complete Knee Solution Minimally Invasive Solutions
MIS Technology Femoral Finishing Guide, instrumentation used
in total knee arthroplasty procedures. Catalog No. 82015272522,
Recall # Z-0651-2007
CODE
a) Lot 97000414;
b) Lot 97000415;
c) Lot 97000416;
d) Lot 97000417;
e) Lot 97000418
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN., by visit on October 10, 2006. Firm initiated recall is complete.
REASON
The device was cut to an incorrect angle, which may result in an incorrect bone cut.
VOLUME OF PRODUCT IN COMMERCE
5 devices
DISTRIBUTION
MI
___________________________________
PRODUCT
Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system, Recall # Z-0652-2007
CODE
All units. Version 5.0
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions, USA, Inc., Ann Arbor, MI., by letter dated January 29, 2007. Firm initiated recall is ongoing.
REASON
The cardiac calculation feature may incorrectly calculate a derived V max value (reported out lower than it should be) and certain values imported into worksheets and reports may be incorrect due to a software defect.
VOLUME OF PRODUCT IN COMMERCE
62 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Colorado 2 Spinal System, Anterior Plate, REF8639500, for export only,
Rx only, Recall # Z-0653-2007;
b) Colorado 2 Spinal System, Anterior Plate, REF8619500, for export only,
Rx only, Recall # Z-0654-2007
CODE
a) Lot Nos.: 42554, 59143, 74708, 076380, 076520, 81321, 82118,
82119, 82236, 83602, 83667, 98552, 177390, 177420, 229470,
230050, 365740, 662340, 685000, 857100, 877430, 909610,
W05A1351, W05C5778, W05F5388, W05F5389, W05G1030,
W05G2592, W05H1354, W05H7884, W05J1023, W05J1497,
W05J1687, W05J2710, W05J2711, W05L0550, W05L1016,
W06E3829, W06F4111, W06H1671, W06K1299, W06M1486,
W06M1487;
b) Lot Nos.: W04E0149, W04C1938, 553880, 672660, 353150,
355610, 201190, 198840, 947250, 914870, 82549, 81749, 81320,
76967, 65867, 42841, 42842
RECALLING FIRM/MANUFACTURER
Medtronic Sofamor Danek USA Inc., Memphis, TN, by letter on February 2, 2007. Firm initiated recall is ongoing.
REASON
Bone screws may pull though the plate.
VOLUME OF PRODUCT IN COMMERCE
1700 units
DISTRIBUTION
Internationally
___________________________________
PRODUCT
a) Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000;
Catalog No. 16400, Recall # Z-0655-2007;
b) Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000;
Catalog No. 16401, Recall # Z-0656-2007;
c) Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000;
Catalog No. 16405, Recall # Z-0657-2007;
d) Terumo Perfusion System 8000 Base, 5 pump, 220/240v; Model 8000;
Catalog No. 16406, Recall # Z-0658-2007;
e) Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000;
Catalog No. 16410, Recall # Z-0659-2007
CODE
a) Hand crank serial numbers 1240 through 1247;
b) Hand crank serial numbers 1963 through 1986;
c) Hand crank serial numbers 1285 through 1306;
d) Hand crank serial numbers 1197 through 1214;
e) Hand crank serial numbers 1621 and 1622
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by telephone between January 12, 2007 and February 23, 2007. Firm initiated recall is ongoing.
REASON
The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)
VOLUME OF PRODUCT IN COMMERCE
85 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, Recall # Z-0660-2007
CODE
Instrument is manufactured in lots, and traceability is maintained for each lot. A two digit unique identifier is added to the lot number label on the instruments, and programming records are traceable to these identifiers. The following 8 instruments from lot # 0503051 are affected: 0503051 66, 0503051 67, 0503051 68, 0503051 69, 0503051 70, 0503051 71, 0503051 72, and 0503051 73
RECALLING FIRM/MANUFACTURER
Intuitive Surgical, Inc., Sunnyvale, CA, by letter on March 24, 3005. Firm initiated recall is complete.
REASON
The products were incorrectly programmed as training instruments, which allows for 30 uses (surgical procedures) instead of 10 uses.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer, Recall # Z-0661-2007
CODE
Serial Numbers: 037XT6, 0379P5, 037WMJ, 0379P1, 0379P2, 0379P0 Part Number: P05507-10
RECALLING FIRM/MANUFACTURER
Sonosite, Inc., Bothell, WA, by letter on February 5, 2007. Firm initiated recall is complete.
REASON
Laparoscopic ultrasound transducer exceeds the limits specified for radio-frequency emissions by up to 10db.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm, balloon length 4 cm, recommended introducer French size 6, sterile, REF (Global product no.) G26887, REF (order no.) ATB5-35-40-7-4.0, Recall # Z-0665-2007
CODE
Lot: 1820419
RECALLING FIRM/MANUFACTURER
Cook, Inc., Bloomington, IN, by telephone on February 28, 2007. Firm initiated recall is ongoing.
REASON
Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0.
VOLUME OF PRODUCT IN COMMERCE
20 devices
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) superDimension Bronchus System (AAS00016-01), an image-guided localization
system used to guide endoscopic tools to predetermined targets within the pulmonary
tract, Recall # Z-0666-2007;
b) Disposable components of the superDimension Bronchus System: Locatable
Guide Kit (AKI00017-01) and Extended Working Channel (AKI00041-01),
Recall # Z-0667-2007
CODE
a) Serial numbers: S0030019, S030051, S030052, S030054, S030055,
S030058 thru S030062, S030067, S030068, S030077 thru S030081;
S030084, S030085, S030088 thru S030095; S030097 thru S030100,
S030103, S030104, S030105, S030390, S030447, S030449, S0030009,
S0030011, S0030013, S0030014, S0030015, S0030021, S0030022,
S0030026, S0030042, S030043 thru S030050, S030053, S030056,
S030057, S030063, S030064, S030066, S030069 thru S030076, S030082,
S030086, S030087, S030096, S030102, S030477;
b) All codes of disposable system components
(Locatable Guide and Extended Working Channel)
RECALLING FIRM/MANUFACTURER
Recalling Firm: superDimension, Inc. Minneapolis, MN., by letter on November 30, 2006 and by telephone beginning on December 1, 2006.
Manufacturer: Superdimension, Ltd., Herzliya, Israel. Firm initiated recall is ongoing.
REASON
The action is being taken in response to certain incidents that have been reported to the company, one of which concerned an adverse event in which a patient incurred a pneumothorax during a procedure in which a superDimension Bronchus System was used. The biopsy results for the patient were taken from a different area than the confirmed navigation site that was indicated by the system.
VOLUME OF PRODUCT IN COMMERCE
74 Bronchus Systems, 2,000 each of the disposable components
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Matrix2 Detachable Coils, for embolization of intracranial aneurysms. Catalog Number: 497204SR, UPN: M003497204SR0, Catalog Number: 494203, UPN: M0034942030, Recall # Z-0668-2007
CODE
Batch numbers: 8941830 and 8852539
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Target., Fremont, CA., by letter on February 7, 2007.
Manufacturer: Boston Scientific Cork, Ltd., Cork, Ireland. Firm initiated recall is ongoing.
REASON
The product may be missing the temperature indicator label on the inner pouch.
VOLUME OF PRODUCT IN COMMERCE
57 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
BD™ Sensi-Disc™ Ticarcillin TIC-75, in vitro diagnostic, catalog # 231619, package of 10 cartridges, Recall # Z-0669-2007
CODE
Lot 6167435, exp 6/30/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., Sparks, MD., by faxed letter dated February 19, 2007.
Manufacturer: Becton Dickinson Caribe LTD, Cayey, PR. Firm initiated recall is ongoing.
REASON
Antibiotic susceptibility testing reagent was not manufactured according to specifications and may cause ineffective treatment regimen in patients with infections. The recalling firm received customer reports of false susceptibility results.
VOLUME OF PRODUCT IN COMMERCE
528/10 packs
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model SS2000 Patient Side Cart, Model PS2000, Part Number: 380267-01, IS2000, Top Level, 4-Arm, Recall # Z-0670-2007
CODE
System Numbers: SG011, SG012, SG013, SG014, SG017, SG018, SG019, SG020, SG058, and SG094.
RECALLING FIRM/MANUFACTURER
Intuitive Surgical, Inc., Sunnyvale, CA., by service visit on April 12, 2006. Firm initiated recall is complete.
REASON
Da Vinci S Surgical System's spinal pin could limit mechanical motion of the arm and render the system unavailable for surgical use, and may result in system failure and the need to convert to an alternative surgical technique.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
LIFEPAK CR Plus defibrillator. The device is a battery operated, portable automated external defibrillator (AED). The devices are designed for non-professional users and are primarily used in public access defibrillator environments such as airports, schools, or public libraries. Affected part numbers: 3200731-000, 002, 006, 020 through 025, 040, 042, 043, 060, 062, 063, 080 through 084, 102, 103, 104, 120, 122, 124, 125, 140, 143, 145, 160, 163, 180, 182, 183, 202, 203, 222, 223, 242, 260, 261, 263, 282, 284, 400 and 403, and U3200731-002, Recall # Z-0671-2007
CODE
Serial Numbers: 31269543, 31188518, 31271729, 31280480, 31311486, 31682955, 31272026, 31272027, 31188516, 31429363, 30558817, 30540859, 31266744, 31395897, 30943076, 30943001, 30943052, 30943055, 30943065, 30943061, 31244729, 31312681, 31312683, 31305314, 30943073, 30943074, 30942993, 31401299, 30943265, 30943267, 30943269, 30943064, 30943059, 30943054, 30558822, 30943023, 30943021, 30943020, 30943019, 30943018, 30943006, 30943011, 31400288, 31415717, 31389380, 31389382, 31389384, 31389385, 31389386, 31389387, 31389389, 31389390, 31389391, 31389392, 31389467, 31389468, 31036207, 31036229, 31036234, 31036268, 31508665, 31508724, 31508757, 31508769, 31508781, 31729699, 31757625, 31758075, 31758090, 31758114, 31758115, 31758132, 31758164, 31758996, 31335474, 31335476, 31335478, 31335480, 31335481, 31335483, 31335484, 31335487, 31335491, 31269004, 31679120, 31270599, 31271030, 31273782, 31273787, 31273790, 31273817, 31273819, 31273822, 31271038, 31273839, 31273861, 31273874, 31271037, 31273884, 31273885, 31174536, 31508775, 31268954, 31269001, 31188476, 31416439, 31266757, 31266811, 31266812, 31416440, 31174528, 31174532, 30972193, 31441727, 31441728, 31441729, 30888563, 30941563, 31319302, 31319303, 31203500, 31335188, 30848721, 30848792, 30848796, 30848797, 30848801, 30848835, 30848850, 30848865, 30849171, 30849174, 30849176, 30849180, 30849183, 30849184, 30849186, 30849187, 30849189, 30849190, 30849191, 30849193, 30849195, 31176927, 31254373, 31254375, 31255892, 31341356, 31341446, 31341474, 31341478, 31725119, 31271759, 31266749, 30913596, 31174308, 31434956, 30888511, 31179993, 31179994, 31319297, 30558878, 31335477, 31028905, 31508714, 31240363, 31036145, 31036149, 31039891, 31039893, 31811260, 31677434, 31677435, 31677436, 31677437, 31636161, 31636164, 31636165, 31636166, 31636168, 31636169, 31636170, 31636171, 31636172, 31636173, 31636174, 31636175, 31636176, 31636177, 31636178, 31636480, 31773379, 31203487, 31256714, 30558965, 31422465, 31422466, 30558800, 31036198, 31036209, 31036257, 31036281, 31508689, 31508808, 30558978, 31312853, 31028889, 31508694, 31028289, 31462210, 30558988, 30848829, 31268965, 30540791, 30540852, 30540853, 30540858, 30540860, 30540865, 30540866, 30558821, 30558833, 30558848, 30558996, 31335486, 30849188, 31266696, 31247174, 31271724, 31271728, 31307077, 30558910, 31000816, 31305367, 31305368, 31350759, 31386272, 30913599, 30849170, 31247167, 31758928, 31509066, 31028324, 31036274, 30848719, 31313298, 30888509, 31508711, 31692816, 31000915, 30558799, 31247164, 31028910, 31266695, 30913557, 31319292, 31319312, 31319314, 31036269, 31319319, 30558985, 31036288, 30558924, 31179983, 31179984, 31179987, 30698128, 30698129, 30698130, 30698131, 30698132, 30698133, 30698134, 30698136, 30888517, 31508780, 31508787, 31508790, 30888493, 31247169, 30558939, 30888503, 30888499, 31319308, 31247180, 31000755, 31508659, 30991159, 31332304, 31268948, 30913600, 31508782, 31259904, 31247158, 31174298, 30996459, 30996461, 30996462, 30996463, 30996464, 30996465, 30996466, 30996467, 30996468, 31312757, 31342150, 31342182, 31342183, 31342254, 31481822, 31023273, 31292563, 31203486, 31434943, 31434944, 31434948, 31434949, 31434951, 31434952, 31434953, 31434954, 31434955, 30558994, 30558999, 31757985, 31268988, 30774968, 31023432, 31624102, 30783380, 31247173, 31268985, 31335182, 30849185, 30913605, 31758029, 31266746, 31685960, 31268998, 31036233, 30558998, 31260325, 30540787, 30540862, 31437697, 31508786, 30888502, 30558814, 31269042, 31305345, 30558864, 31266594, 30848873, 31000842, 30558987, 30558929, 31524334, 31524641, 31268950, 30540834, 31319309, 31268961, 30888546, 31305312, 31000914, 31269041, 30880773, 31796392, 31247168, 31319293, 31174539, 31387963, 31405736, 31405739, 31470265, 31485850, 31202868, 31202869, 31758007, 31758026, 31178474, 30972383, 31335169, 31335174, 31335175, 31335176, 31335187, 31335189, 31335190, 31335192, 31247151, 31485821, 31387952, 31508662, 31508728, 31508747, 31389395, 30849175, 31000827, 31188477, 31188480, 31188482, 31188483, 31188486, 31188490, 31188497, 31188503, 31188504, 31188505, 31188509, 31188510, 31188511, 31203505, 31203506, 31203507, 31203508, 31203509, 31203511, 31203512, 31203513, 31247150, 31247152, 31264440, 31264489, 31264500, 31264502, 31264503, 31264504, 31264505, 31264506, 31264508, 31264512, 31264513, 31264515, 31264518, 31264520, 31264521, 31264878, 31268942, 31268945, 31268946, 31268947, 31268951, 31268956, 31268971, 31268981, 31268983, 31268987, 31268991, 31269008, 31269009, 31269028, 31269033, 31269034, 31269035, 31269039, 31269043, 31269052, 31319299, 31319307, 31319315, 31416416, 31416436, 31416437, 31416441, 31028276, 31036188, 31036193, 31036195, 31036235, 31028201, 31028208, 31028270, 31036212, 31036218, 31036227, 31508656, 31508661, 31508682, 31508686, 31508698, 31508701, 31508703, 31508705, 31508707, 31508709, 31508733, 31508749, 31508751, 31508759, 31508765, 31508801, 31508806, 31509054, 31509060, 31757916, 31757917, 31757924, 31757927, 31757945, 31757981, 31757987, 31757989, 31758006, 31758015, 31758031, 31758046, 30558916, 30558925, 31359230, 31359252, 31359254, 31359229, 31508741, 31000882, 31028903, 31437690, 31437691, 31437692, 31437693, 31437694, 31437695, 31437696, 31437698, 31179989, 31319311, 31247147, 30941567, 31270562, 30880776, 31000841, 31000843, 31000844, 31000845, 31000878, 31000892, 31179998, 31508699, 31508722, 31508729, 31000773, 30535064, 30888505, 30559031, 31028886, 31174193, 30888539, 30880769, 30880770, 30880771, 31269059, 31319290, 31319291, 31319320, 30558839, 31266742, 31344933, 31345458, 31508678, 30990981, 30905391, 30909781, 31178386, 31036255, 31305353, 31677433, 31509064, 31513690, 31205197, 31759128, 31485330, 31508744, 31258799, 31313396, 31313397, 31313601, 31313602, 31313604, 31205300, 31338330, 31338331, 31341569, 31341571, 31341572, 31346964, 31347000, 31816901, 31205172, 31462170, 31205128, 31401174, 31342149, 31264385, 31333111, 31176069, 31344231, 30684352, 31336943, 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30505890, 30505899, 30495437, 30505326, 30509722, 30509724, 30509726, 30509728, 30509730, 30509742, 30509744, 30509746, 30509748, 30509750, 30509752, 30509757, 30512927, 30513170, 30513172, 30513175, 30513178, 30515083, 30515782, 30515784, 30515786, 30515788, 30516079, 30519062, 30519064, 30519066, 30522348, 30522350, 30522352, 30522354, 30522356, 30522358, 30522360, 30522362, 30522364, 30522366, 30522368, 30522370, 30522372, 30522374, 30522376, 30522380, 30522382, 30522384, 30522386, 30522388, 30522390, 30522392, 30522394, 30522396, 30606949, 30606950, 30606953, 30606955, 30606956, 30606958, 30475791, 30514878, 30610394, 30613818, 30860160, 30885002, 30757559, 30757976, 30757978, 30757985, 30757988, 30757999, 30758011, 30758012, 30758015, 30929172, 30929175, 30462149, 30462151, 30464702, 30465432, 30465442, 30468448, 30468453, 30468456, 30468468, 30468474, 30468477, 30468523, 30468539, 30468543, 30518537, 30561410, 30561412, 30561432, 30490082, 30490113, 30490159, 30490166, 30761994, 30761996, 30770614, 30770629, 30770630, 30770642, 30770644, 30495129, 30495131, 30495141, 30495151, 30495157, 30941471, 30941472, 30943081, 30943086, 30943093, 30943094, 30943100, 30943104, 30943105, 31184578, 31184579, 31194829, 31194830, 31194831, 31194832, 31194833, 31194834, 31194835, 31194836, 31194837, 31194838, 31194839, 31194840, 31194841, 31194843, 31194844, 31194845, 31194846, 31194847, 31194849, 31194850, 31194851, 31194852, 31194853, 31194854, 31194855, 31194856, 31194857, 31194858, 31194859, 31194860, 31194861, 31194862, 31194863, 31194864, 31194866, 31194867, 31194868, 31194869, 31194870, 31194871, 31195102, 31195224, 31195225, 31195226, 31195233, 31278231, 31278233, 31278238, 31278242, 31278243, 31310225, 31310226, 31310228, 31310229, 31310230, 31310232, 31310233, 31310234, 31310235, 31310240, 31310241, 31310243, 31310244, 31310247, 31310249, 31310250, 31310251, 31310252, 31310253, 31310254, 31310255, 31310256, 31310257, 31310258, 31310259, 31310263, 31310264, 31310265, 31310266, 31310267, 31310268, 31310269, 31310270, 31310271, 31310272, 31310274, 31310275, 31310276, 31310277, 31310280, 31310281, 31310282, 31310283, 31310284, 31310285, 31310287, 31310288, 31310289, 31310290, 31310292, 31310293, 31310294, 31310296, 31318794, 31318795, 31318797, 31318798, 31203437, 31203438, 31203444, 31203445, 31203446, 31389396, 31569202, 31569203, 31569204, 31569207, 31637430, 31637431, 31637432, 31637433, 31637434, 31637445, 31637450, 31754633, 31754636, 31754637, 31754638, 31754641, 31754642, 31754643, 31754644, 31754645, 31754646, 31754647, 31754648, 31754649, 31754650, 31754651, 31775641, 31775644, 31775647, 31775649, 31818072, 31818073, 31818074, 31818075, 31818076, 31818077, 31627626, 31627627, 30632082, 30694599, 30799349, 30990674, 31281190, 31281191, 31281192, 31281193, 31281194, 31281195, 31281196, 31281197, 31281198, 31281199, 31281200, 31281201, 31281202, 31281203, 31281204, 31281205, 31281206, 31281207, 31281208, 31281209, 31281210, 31281211, 31281212, 31281213, 31281214, 31281215, 31281216, 31281217, 31281218, 31281219, 31281220, 31281221, 31281222, 31281224, 31281225, 31281226, 31281227, 31281228, 31281229, 31281230, 31281231, 31281232, 31281233, 31292630, 31304928, 31304929, 31633677, 31634683, 31278291, 31673707, 30469592, 30469598, 30469602, 30469604, 31074433, 31280482, 31280483, 31495184, 31495185, 31334883
RECALLING FIRM/MANUFACTURER
Medtronic Emergency Response Systems, Inc., Redmond, WA., by letters on March 2, 2007. Firm initiated recall is ongoing.
REASON
LIFEPAK CR Plus defibrillators with software version 1.16 or lower may miscalculate the HLC battery capacity and result in the CHARGE-PAK battery charger icon/indicator to display and falsely indicate battery needs replacement.
VOLUME OF PRODUCT IN COMMERCE
13,835 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Recall # Z-0673-2007
CODE
Lot: 063533
RECALLING FIRM/MANUFACTURER
Remington Medical, Inc., Alpharetta, GA, by telephone on January 19, 2007. Firm initiated recall is complete.
REASON
Pouches were not sealed prior to sterilization.
VOLUME OF PRODUCT IN COMMERCE
192 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Conical Reamer, instrument for shoulder arthroplasty, REF no. 00-4309-021-00, Recall # Z-0675-2007
CODE
Lot: 60605829
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN, by letter dated February 1, 2007. Firm initiated recall is ongoing.
REASON
The reamer may lock up on the threads of the reamer body rather than spin freely as intended by design.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Swiss Lithocast Ultra Ultrasound Handpiece (EMS-PN: EL-236) used in combination with Swiss Lithoclast Ultra System, Recall # Z-0684-2007
CODE
Units manufactured prior to January 2003.
RECALLING FIRM/MANUFACTURER
E.M.S. – Electro Medical Systems SA, Nyon, Vaud, Switzerland, by letter on April 22, 2005. Firm initiated recall is ongoing.
REASON
Handpiece may become dislodged causing cable damage and possible electric shock.
VOLUME OF PRODUCT IN COMMERCE
160 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Plicator EPS Plication System, Catalog Number: 160-01128R, Recall # Z-0685-2007
CODE
Serial numbers: 43, 52, 54, 59, 63, 65, 68, 72, 96
RECALLING FIRM/MANUFACTURER
NDO Surgical, Inc., Mansfield, MA, by letter on January 26, 2007. Firm initiated recall is ongoing.
REASON
Device arm may fail to open after being deployed and require surgical intervention to remove.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Aspyra, Inc. CyberMed Version 2.1 Pharmacy Software, Recall # Z-0686-2007
CODE
Version 2.1
RECALLING FIRM/MANUFACTURER
Aspyra, Inc., Calabasas, CA, by letter on January 31, 2007. Firm initiated recall is ongoing.
REASON
Medications prescribed for one patient were printed on the Medication Administration Record (MAR) of another patient.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Product Description: HTA Console System, 110 Volt, Product Number: 56000
(HTA system is a software-controlled hysteroscopic thermal endometrial
ablation system), Recall # Z-0687-2007;
b) HTA Console System, 230 Volt, English, Product Number: 560010
(HTA system is a software-controlled hysteroscopic thermal endometrial
ablation system), Recall # Z-0688-2007;
c) HTA Console System, 230 Volt, Product Number: 56001 DO- English
Demonstration Evaluation Unit (HTA system is a software-controlled
hysteroscopic thermal endometrial ablation system), Recall # Z-0689-2007;
d) HTA Console System, 230 Volt , French, Product Number: 56001FO
(HTA system is a software-controlled hysteroscopic thermal endometrial
ablation system), Recall # Z-0690-2007;
e) HTA Console System, 230 Volt , Italian, Product Number: 56001 IO
(HTA system is a software-controlled hysteroscopic thermal endometrial
ablation system), Recall # Z-0691-2007;
CODE
a) Unit Numbers: N1190JC, N1191JC, N1192JC, N1194JC, N1197JC, N1199JC,
N1200JC, N1201JC, N1203JC, N1204JC, N1205JC, N1206JC, N1208JC,
N1210JC, N1211JC, N1214JC, N1215JC, N1217JC, N1218JC, N1220JC,
N1222JC, N1226JC, N1227JC, N1229JC, N1230JC, N1231JC, N1232JC,
N1233JC, N1234JC, N1235JC, N1237JC, N1238JK, N1239JF, N1240JF,
N1241JF, N1242JF, N1243JF, N1245JF, N1247JF, N1251JF, N1252JF,
N1253JF, N1254JF, N1255JF, N1257JF, N1258JF, N1259JF, N1261JF,
N1262JF, N1263JF, N1264JF, N1266JF, N1267JF, N1268JF, N1269JF,
N1294JI, N1295JI;
b) Unit Numbers: IN0335JC, IN0337JC, IN0341JD, IN0342JD, IN0343JD,
IN0344JE, IN0345JE, IN0347JE, IN0348JE, IN0349JE, IN0352JG,
IN0353JG, IN0355JG, IN0356JG;
c) Unit Numbers: IN0335JC, IN0344JE, IN0345JE, IN0349JE, IN0352JG,
IN0353JG, IN0355JG, IN0356JG;
d) Unit Numbers: IN0350JG, IN0351JG;
e) Unit Numbers: IN0339JC, IN0340JC
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Natick, MA., by letter dated January 24, 2007.
Manufacturer: Nexcore Technology, Inc., Waldrick, NJ. Firm initiated recall is ongoing.
REASON
Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree C into uterus) if in use during the recirculation/heating phase of treatment.
VOLUME OF PRODUCT IN COMMERCE
51 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Recall # Z-0695-2007
CODE
Serial numbers: PA0101 thru PA0681, PA1001 thru PA1774
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gambro Renal Products, Inc., Lakewood, CO., by letter on December 19, 2006.
Manufacturer: Gambro Lundia Ab - Disposables Division, Lund, Sweden. Firm initiated recall is ongoing.
REASON
Under certain conditions, * an excessive amount of anticoagulant may be infused into the patient. (* interruption of a self-test by an alarm and obstruction of the access lines)
VOLUME OF PRODUCT IN COMMERCE
153 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Boston Scientific SpyGlass Visualization Probe Reference Number: 4603,
UPN M00546030, Recall # Z-0696-2007;
b) Boston Scientific SpyGlass Ocular Reference Number: 4604,
UPN M00546040, Recall # Z-0697-2007;
c) Boston Scientific SpyGlass Light Cable Reference Number: 4621
UPN M00546210, Recall # Z-0698-2007;
d) Boston Scientifica SpyGlass Camera Ref Number: 4610
UPN M00546100, Recall # Z-0699-2007
CODE
a) Lot number: 527301, 527302, 533202, 625401, 628902, 63001,
633201, 635501, 702901;
b) Lot Number: 532202;
c) Lot Number: 355R;
d) Lot Numbers: 061005, 061006, 061007, 061009, 061010, 0161011,
061012, 610130, 61014, 061015, 0610106, 061017
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Natick, MA, by letter dated February 1, 2007. Firm initiated recall is ongoing.
REASON
SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe
VOLUME OF PRODUCT IN COMMERCE
115 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body), Recall # Z-0704-2007
CODE
InstaTrak 3500 Plus systems with version 5.1 software. The accessory involved: Shunt Guide (P/N 1004362) when used with version 5.1 software.
RECALLING FIRM/MANUFACTURER
GE OEC Medical Systems,Inc., Salt Lake City, UT, by firm representative visit beginning in April, 2004. Firm initiated recall is complete.
REASON
Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software.
VOLUME OF PRODUCT IN COMMERCE
91 units
DISTRIBUTION
Nationwide and Internationally
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
___________________________________
PRODUCT
BD Visitec Irrigating Cytosome, for use in cataract surgery. Ref 581618, Recall # Z-0672-2007
CODE
Lot Number: 6181868
RECALLING FIRM/MANUFACTURER
BD Opthalmic Systems, Waltham, MA., by telephone on March 2, 2007 and followed with a letter. Firm initiated recall is ongoing.
REASON
Mislabeled: Carton label incorrectly labeled as Ref 581618 (.40 X 16mm) , may contain product Ref 581617 (.50 x 16mm)
VOLUME OF PRODUCT IN COMMERCE
1,500 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
The Precision Implantable Pulse Generator, Model Number SC-1110, Recall # Z-0700-2007
CODE
161773, 161898, 161934, 161969, 160753, 102331, 103463, 103497, 103525, 160041, 160077, 160080, 160088, 160090, 160091, 160092, 16009, 160096, 160103, 160104, 160105, 160107, 160108, 160110, 160113, 160115, 160141, 160142, 160144, 160146, 160602, 161028, 161065, 161222, 161350, 161415, 161425, 161430, 161457, 161484, 161497, 161508, 161579, 161644, 161658, 161674, 161680, 161681, 161700, 161751, 161760, 161790, 161807, 161840, 161853, 810024, 810051
RECALLING FIRM/MANUFACTURER
Advanced Bionics Corp., Sylmar, CA, by visit on January 31, 2007 and by letter on March 8, 2007. Firm initiated recall is ongoing.
REASON
The Precision Implantable Pulse Generator with firmware Revision 3.01 incorrectly reports an error condition for a valid output from its self internal check.
VOLUME OF PRODUCT IN COMMERCE
5 unimplanted units; 52 implanted units
DISTRIBUTION
Nationwide and PR
END OF ENFORCEMENT REPORT FOR APRIL 4, 2007
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