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The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
October 31, 2007
07-44
RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS I
___________________________________
PRODUCT
Herring of the special ambassador (7 Uzlov), Net Wt. 1300g/45,85 oz --- The product is packaged in sealed metal can. The product is labeled mostly in Russian with a white Nutrition Facts Panel label in English. INGREDIENTS: fish, salt, sugar, vinegar, water, E211. PRODUCT OF RUSSIA --- According to NYSDAM's lab report, the fish was not eviscerated. The fish is 8 inches in length. UPC Barcode 4 60556 000153, Recall # F-024-8
CODE
UPC Barcode only
RECALLING FIRM/MANUFACTURER
Krasniy Oktyabr, Inc., USA, Brooklyn, NY, by press release, telephone and letters on August 7, 2007. Firm initiated recall is complete.
REASON
The processed fish was uneviscerated based on sampling and analysis by New York State Department of Agriculture & Markets. This posed a health risk if consumed as it may have contained Clostridium botulinum spores which can cause botulism.
VOLUME OF PRODUCT IN COMMERCE
30 cases (8 – 1300 g cans per case)
DISTRIBUTION
NY
___________________________________
PRODUCT
Harry and David Hearthside Soups Southwestern Chicken Chili Mix in 12.7 oz. clear plastic package tied at the top with a cream and red colored ribbon. The bottom of the bag contains a sticker stating “Fajita Chili”, Recall # F-027-8
CODE
8221-1 on price sticker on the bottom of the package.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bear Creek Operations, Inc., DBA Harry and David’s, Medford, OR, by e-mail on September 10, 2007, press release on September 12, 2007 and stores signs posted beginning September 13, 2007.
Manufacturer: Conifer Specialties, Inc., Woodinville, WA. Firm initiated recall is complete.
REASON
Product contains undeclared allergen – whey, a milk product.
VOLUME OF PRODUCT IN COMMERCE
1,440 bags
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS II
___________________________________
PRODUCT
Hood Vanilla Ice Cream Sandwiches, 12 Pack (12-3.75 fl. oz.) UPC Code: 44100 23423, Recall # F-022-8
CODE
Julian Code Dates: 1667 thru 2307
RECALLING FIRM/MANUFACTURER
Recalling Firm: H. P. Hood, Inc., Chelsea, MA, by letter dated August 24, 2007.
Manufacturer:: H. P. Hood, Inc., Suffield, CT. Firm initiated recall is complete.
REASON
Product contains undeclared color – FD&C Yellow # 5.
VOLUME OF PRODUCT IN COMMERCE
21,093 cases
DISTRIBUTION
CT, FL, MA, ME, and VT
___________________________________
PRODUCT
Hana® brand Sweet Candy, 6.5 oz plastic packages, 20 packages per case, packages labeled in part ***(Compeito) Kasugai***Product of Japan***, Recall # F-023-8
CODE
Item #09315J
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rhee Brothers Inc., Columbia, MD, by letter and visit on August 25, 2007.
Manufacturer: Kasugai Confectionery/ Kasugai Factory, Kasugai City, Japan. Firm initiated recall is complete.
REASON
Product contains a undeclared color - FD&C Yellow #6.
VOLUME OF PRODUCT IN COMMERCE
2,040 packages
DISTRIBUTION
Eastern half of the US
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
Metaboslim All Natural Fat Eater Apple Cider Vinegar Dietary Supplement, 60-capsule bottles, UPC 92483 00102, Confidence USA, Recall # D-012-2008
CODE
Lot 3001006, exp. 102009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Confidence Inc., Port Washington, NY, by press release on August 17, 2007 and by letters on August 20 and 21, 2007.
Manufacturer: Island Vitamins Inc. Farmingdale, NY. Firm initiated recall is ongoing.
REASON
Product was found to contain undeclared sibutramine, an active pharmaceutical ingredient used for weight loss in treatment of obesity.
VOLUME OF PRODUCT IN COMMERCE
4,180 bottles
DISTRIBUTION
Canada
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
BETCO WINNING HANDS ULTRA MILD ANTIBACTERIAL SKIN CLEANSER, Triclosan 0.30%, NET CONTENTS 30.4 fl. oz. (900 mL) bag in box, 37.2 fl. oz. (1100 mL) bag in box, 67.7 fl. oz. (2000 mL) bag in box, 1 Gallon (3.78L) bottles, Recall # D-008-2007
CODE
1 Gallon Bottle (4-1 Gallon Containers per case) Lots 1088639, 1089891, 1087387 --- 900 mL BAG IN BOX (12-900 mL per case) Lot 1088201 --- 1100 mL BAG IN BOX (10-1100 mL per case) Lot 1088201 --- 2000 mL BAG IN BOX (4 - 2000 ml per case) Lot 1090335
RECALLING FIRM/MANUFACTURER
Betco Corp., Ltd, Toledo, OH, by letters on August 24, 2007. Firm initiated recall is ongoing.
REASON
Microbial contamination of Non Sterile Product; the product is contaminated with Pseudomonas aeruginosa.
VOLUME OF PRODUCT IN COMMERCE
1,212 gallons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Dentakleen Cavity Fighting Fluoride Toothpaste, Great Regular Flavor, 6.4 oz tubes
with free toothbrush, labeled ingredients include Sodium Monofluorophosphate
0.7%. Made in China, Recall # D-022-2008;
b) Dentakleen Fluoride Toothpaste, Fresh Mint Flavor, 6.4 oz tubes with free toothbrush,
labeled ingredients include Sodium Monofluorophosphate 0.7%. Made in China,
Recall # D-023-2008;
c) Dentakleen Fluoride Toothpaste, Cool Winterfresh Taste, 6.4 oz tubes with free
toothbrush, labeled ingredients include Sodium Monofluorophosphate 0.7%. Made in
China, Recall # D-024-2008;
d) Denta-Kleen Junior Fluoride Toothpaste, Blueberry Flavor, 50 g tubes with bonus
toothbrush, labeled ingredients include Monofluorophosphate 500 ppm. Made in
China, Recall # D-025-2008;
e) Denta-Kleen Junior Fluoride Toothpaste, Strawberry Flavor, 50 g tubes with bonus
toothbrush, labeled ingredients include Monofluorophosphate 500 ppm. Made in
China, Recall # D-026-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: One Two For You, Inc., Toa Baja, PR, by visit on June 12, 2007.
Manufacturer: Goldcredit International Enterprises, Wuxi, Jiangsu, China (Mainland). Firm initiated recall is complete.
REASON
Toothpaste from China containing the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
18,720 units
DISTRIBUTION
PR
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Fougera CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM USP 1%/0.05% (base), a) NET WT 15 grams (NDC 0168-0258-15) and b) NET WT 45 grams (NDC 0168-0258-46), Rx only, Recall # D-009-2008
CODE
a) Lot T957 (exp. 11/07);
b) Lots T608 (exp. 9/07), T609 (exp. 9/07), T755 (exp. 11/07), T793 (exp. 11/07), U131 (exp. 12/07), U132 (exp. 12/07), U268 (exp. 1/08), U269 (exp. 1/08), U638 (exp. 2/08), U639 (exp. 2/08), U961(exp. 2/08), U962(exp. 4/08), U963 (exp. 4/08), W098 (exp. 7/08), W099 (exp. 7/08)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Altana, Inc., Melville, NY, by letters on October 4, 2007.
Manufacturer: Altana, Inc., Hicksville, NY. Firm initiated recall is ongoing.
REASON
Out-of-specification result for homogeneity (low) at 21-month test station (controlled room temperature). Result of 88.6% vs. specification of 90.0% -110.0% of the mean for homogeneity.
VOLUME OF PRODUCT IN COMMERCE
772,814 units
DISTRIBUTION
Nationwide, PR, Guam, and Guyana
___________________________________
PRODUCT
Pancrecarb MS-4 (pancrelipase) Delayed-Release Capsules, professional sample, 20-capsule bottle, Rx only, NDC 59767-002-03, Recall # D-013-2008
CODE
Lot: 7C04A, exp. 04/09
RECALLING FIRM/MANUFACTURER
Digestive Care, Inc., Bethlehem, PA, by letter dated September 26, 2007. Firm initiated recall is ongoing.
REASON
Inner foil seal does not adhere to the bottles.
VOLUME OF PRODUCT IN COMMERCE
1,134 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Ibuprofen Tablets, 200 mg tablets, 2 tablets per pack, OTC, Recall # D-014-2008
CODE
Lot: HA09707, exp. 12/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Generic Pharmacetical Services, Inc., Hauppauge, NY, by telephone on October 5, 2007, by letters, e-mail and fax on October 11, 2007.
Manufacturer: Interpharm, Inc., Hauppauge, NY. Firm initiated recall is ongoing.
REASON
The bulk lot had failed USP limit for 4-IBA impurity during stability testing.
VOLUME OF PRODUCT IN COMMERCE
1,412,376 pouches (2 tablets per pouch)
DISTRIBUTION
WA and CA
___________________________________
PRODUCT
a) Ibuprofen Tablets USP, 200 mg, white or brown color, packaged in bulk cartons for
further processing only and in bottles of 250 tablets, 500 tablets, and 1000 tablets.
Bulk product manufactured for: 1) Leiner Health Products, LLC (HA05107);
2) Generic Pharmaceutical Services, (HA09707); 3) Kirk Pharmaceuticals,
(HA09907). Product in bottles distributed under following labels: 1) Rugby
Laboratories, 2) InterPharm, Recall # D-016-2008;
b) Ibuprofen Tablets USP, 400 mg, packaged in bulk carton for further processing only,
Recall # D-017-2008;
c) Ibuprofen Tablets USP, 600 mg, packaged in bulk carton for further processing only,
Recall # D-018-2008;
d) Ibuprofen Tablets USP, 800 mg, packaged in bulk carton for further processing only,
Recall # D-019-2008;
e) Ibuprofen Tablets USP, 200 mg, brown color caplet, packaged in bulk carton for
further processing only, Recall # D-020-2008
CODE
a) Bulk lots: HA05107, exp. 12/08; HA09707, exp. 12/09; HA09907, exp. 12/09;
and packaged lot HA09807, exp. 12/09;
b) Bulk lot HA02607, exp. 06/09;
c) Bulk lot HA07607, exp. 06/09;
d) Bulk lots: HA06907, exp. 06/09 and HA15507, exp. 06/09;
e) Bulk lot HA18107, exp. 12/08
RECALLING FIRM/MANUFACTURER
Interpharm, Inc., Hauppauge, NY, by letters, fax and e-mail on October 3, 2007 and October 16, 2007. Firm initiated recall is ongoing.
REASON
Product cannot meet impurity specification throughout shelf life.
VOLUME OF PRODUCT IN COMMERCE
200mg: 4,648 bottles & 11,471,661 tablets; 400mg: 1,456,558 tablets; 600mg: 964,062 tablets; 800mg: 2,908,240 tablets; 200mg brown caplets: 2,858,582
DISTRIBUTION
NY, PA, IL, MI, OH, GA, FL, TX, CA, KY
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0129-08
CODE
Unit: 030GV26692
RECALLING FIRM/MANUFACTURER
American Red Cross, Northeastern, Ashley, PA, by letter dated May 3, 2007. 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
GA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0130-08
CODE
Unit: Y71559
RECALLING FIRM/MANUFACTURER
Central Pennsylvania Blood Bank, Hummelstown, PA, by letter dated March 6, 2007. 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
PA
___________________________________
PRODUCT
a) Platelets, Recall # B-0133-08;
b) Fresh Frozen Plasma, Recall # B-0134-08;
CODE
a) and b) Unit: KH60878
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on March 30, 2007. Firm initiated recall is complete.
REASON
Blood products, which were manufactured from a whole blood unit in which an associated blood component contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0135-08
CODE
Units: 12FJ73150, 12FJ73151, 12FJ73152, 12FJ73153, 12FJ73154, 12FJ731555, 12FJ73160, 12FJ73161, 12FJ73163, 12FJ73164, 12FJ73165, 12FJ73166, 12FJ73167, 12FJ73171, 12FJ73172, and 12FJ73173
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by letter dated May 26, 2006. Firm initiated recall is complete.
REASON
Blood products, which may have been shipped under potentially unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
NC and VA
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-0140-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0141-08
CODE
a) and b) Units: 2790243
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile and telephone on April 25, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who emigrated from an area considered at risk for human immunodeficiency virus (HIV) Group O, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Switzerland
___________________________________
PRODUCT
Red Blood Cells Pheresis Leukocytes Reduced, Recall # B-0146-08
CODE
Unit: 2746224
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on July 19, 2005. Firm initiated recall is complete.
REASON
Blood product, which was not quality control tested following collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0147-08
CODE
Units: 7093496 (Parts 1, 2, & 3)
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June 17, 2005. Firm initiated recall is complete.
REASON
Blood products, which were inappropriately distributed in single storage bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX
___________________________________
PRODUCT
a) Cryoprecipitated AHF, Recall # B-0142-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0143-08;
c) Recovered Plasma Cryoprecipitate Reduced, Recall # B-0144-08
CODE
a), b), and c) Unit: 5663470
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute – Sylvan N Goldman Center, Oklahoma City, OK, by fax beginning August 24, 2006.
Manufacturer: Oklahoma Blood Institute, Northwest Oklahoma Blood Institute, Enid, OK. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information regarding a history of receiving a tattoo and treatment for gonorrhea, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX, OK, CA, and Switzerland
___________________________________
PRODUCT
Platelets Pheresis, Recall # B-0148-08
CODE
Unit: LX06806
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on February 21, 2007. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0054-08;
b) Plasma, Cryoprecipitate Reduced, Recall # B-0055-08
CODE
a) and b) Unit: 71S836407
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on November 8, 2006. Firm initiated recall is complete.
REASON
Blood products, associated with a unit of Cryoprecipitated AHF that contained fibrin strands, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL, FL, and GA
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0125-08
CODE
Units: 2213346, 2213359, 2223425, 2213375, and 2223446
RECALLING FIRM/MANUFACTURER
Bergen Comm Reg Blood Center, Paramus, NJ, by letter dated March 23, 2007. Firm initiated recall is ongoing.
REASON
Blood products, which were incorrectly labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
NJ, NY, and SC
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0145-08
CODE
Unit: 5663470
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute – Sylvan N Goldman Center, Oklahoma City, OK, by fax beginning August 24, 2006.
Manufacturer: Oklahoma Blood Institute, Northwest Oklahoma Blood Institute, Enid, OK. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who provided post donation information regarding a history of receiving a tattoo and treatment for gonorrhea, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX, OK, CA, and Switzerland
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT
a) Medtronic Sprint Fidelis 6930 Steroid eluting, tripolar, ventricular lead with tined tip
and right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed
for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0067-2008;
b) Medtronic Sprint Fidelis 6931 Steroid eluting, tripolar, screw-in, ventricular lead
with right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed
for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0068-2008;
c) Medtronic Sprint Fidelis 6948 Steroid eluting, quadripolar, ventricular lead with tined
tip and right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil
electrodes. Sterile. This lead is designed for pacing, sensing, cardioversion and
defibrillation therapies, Recall # Z-0069-2008;
d) Medtronic Sprint Fidelis 6949 Steroid eluting, quadripolar, screw-in, ventricular lead
with right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes.
Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation
therapies, Recall # Z-0070-2008
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic, Inc., Rhythm Management, Minneapolis, MN, by press release, FDA Statement and letter dated October 15, 2007.
Manufacturer: Medtronic Puerto Rico, Inc., Villalba Pr, PR. Firm initiated recall is ongoing.
REASON
Medtronic Cardiac Rhythm Disease Management has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949). Medtronic, its Independent Physician Quality Panel, and the President of the Heart Rhythm Society (HRS), do not recommend that patients seek prophylactic replacement of Sprint Fidelis leads, as the risks of removal or insertion of another lead exceed the small risk to patients of a lead fracture. Medtronic has provided patient management recommendations that should reduce risks in the affected population and recommends that patients with questions consult their physicians. Information is also available for patients and physicians at www.medtronic.com/fidelis. This decision is based on a variety of factors that, when viewed together, indicate that suspending distribution is the appropriate action. Lead fractures may present clinically as audible alerts, inappropriate shocks and/or loss of output.
VOLUME OF PRODUCT IN COMMERCE
Approximately 235,000 devices
DISTRIBUTION
Nationwide and Internationally
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
a) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup
Ref.: 74120144. Hip implant component, Recall # Z-0017-2008
b) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 46 mm cup
Ref.: 74120146. Hip implant component, Recall # Z-0018-2008
c) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 48 mm cup Ref.:
74120148. Hip implant component, Recall # Z-0019-2008;
d) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.:
74120150. Hip implant component, Recall # Z-0020-2008;
e) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 52 mm cup Ref.:
74120152. Hip implant component, Recall # Z-0021-2008;
f) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.:
74120154. Hip implant component, Recall # Z-0022-2008;
g) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 56 mm cup Ref.:
74120156. Hip implant component, Recall # Z-0023-2008;
h) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.:
74120158. Hip implant component, Recall # Z-0024-2008;
i) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 60 mm cup Ref.:
74120160. Hip implant component, Recall # Z-0025-2008;
j) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.:
74120162. Hip implant component, Recall # Z-0026-2008;
k) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.:
74120164. Hip implant component, Recall # Z-0027-2008;
l) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.:
74120166. Hip implant component, Recall # Z-0028-2008;
m) Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 50 mm cup Ref.:
74120250. Hip implant component, Recall # Z-0029-2008;
n) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.:
74120250. Hip implant component, Recall # Z-0030-2008;
o) Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 54 mm cup Ref.:
74120254. Hip implant component, Recall # Z-0031-2008;
p) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.:
74120258. Hip implant component, Recall # Z-0032-2008;
q) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.:
74120262. Hip implant component, Recall # Z-0033-2008
CODE
a) Lot Numbers: 64739, 66135, 66857, 67626, 67663, 67958, 67860;
b) Lot Numbers: 66608, 65074, 65569, 66778, 66780, 64803;
c) Lot Numbers: 66781, 63743, 64110, 64498, 65674;
d) Lot Numbers: 65654, 64188, 67081, 67582, 67421, 67945, 68035;
e) Lot Numbers: 64797, 64798, 64846, 65084, 67553, 67555, 67557, 67871, 67388,
67589, 67706;
f) Lot Numbers: 65543, 66655, 63286, 63765, 64773, 65676, 66861, 67510;
g) Lot Numbers: 64767, 65679, 65943, 63452, 64595, 64800, 64840, 64841, 64856,
64858, 65004, 65005, 65075, 65078, 65080, 65082, 65478, 65529, 65533, 65942,
65946, 66109, 66131, 66621, 66878, 67220, 67346;
h) Lot Numbers: 65655, 64496, 65081, 66111, 67874, 67477, 67925, 67940;
i) Lot Numbers: 64599, 65540, 65501, 65660, 66862, 66862, 66886, 66926, 67062,
67218, 67223, 67345, 67560, 67576, 67886, 67887, 67923, 68299, 68302, 67704,
67944;
j) Lot Numbers: Lot Numbers: 64740, 64957, 65657, 67343, 67580, 67971;
k) Lot Numbers: 64178, 65670, 66424, 66802;
l) Lot Numbers: 66700, 67558, 67630, 67733;
m) Lot Numbers: 66612, 66999;
n) Lot Number 66925;
o) Lot Number 64868;
p) Lot Number 66949;
q) Lot Number 67216
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith and Nephew, Inc., Memphis, TN, by telephone on July 12, 20007 and letter dated July 24, 2007.
Manufacturer: Finsbury Orthopaedics, Leatherhead, UK. Firm initiated recall is ongoing.
REASON
The carton label may not reflect the correct size of the Acetabular cup.
VOLUME OF PRODUCT IN COMMERCE
176 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Urinary Drainage Bags: 500ml Disposable Urinary Leg Bag (Order number: 500-D) and 1000ml Disposible Urinary Leg Bag (Order number 1000-D) -- Sterile Fluid Path, For Single Use Only, Recall # Z-0058-2008
CODE
Lot # 20070423 (500-D), and Lot #20070420 (1000-D)
RECALLING FIRM/MANUFACTURER
Remington Medical, Inc., Alpharetta, GA, by letter dated July 23, 2007. Firm initiated recall is ongoing.
REASON
Sterility, inadequate -- Pathway may not be sterile as labeled.
VOLUME OF PRODUCT IN COMMERCE
45,000 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
HeartStart XL Defibrillator/Monitor, Model: M4735A, Recall # Z-0062-2008
CODE
S/N's: Lot numbers(s) or serial number(s) US00453446 US00453452 US00453458 US00453459 US00453460 US00453461 US00453463 US00453465 US00453466 US00453471 US00453472 US00453475 US00453477 US00453479 US00453486 US00453487 US00453488 US00453489 US00453490 US00453491 US00453492 US00453513 US00453514 US00453515 US00453516 US00453517 US00453541 US00453542 US00453543 US00453544 US00453545 US00453546 US00453547 US00453548 US00453549 US00453550 US00453552 US00453553 US00453564 US00453565 US00453566 US00453596 US00453597 US00453598 US00453599 US00453601 US00453602 US00453603 US00453604 US00453607 US00453609 US00453610 US00453611 US00453613 US00453614 US00453615 US00453616 US00453617 US00453618 US00453619 US00453621 US00453622 US00453623 US00453624 US00453631 US00453634 US00453635 US00453636 US00453637 US00453638 US00453640 US00453641 US00453642 US00453645 US00453646 US00453647 US00453648 US00453649 US00453650 US00453651 US00453652 US00453653 US00453654 US00453655 US00453656 US00453657 US00453658 US00453659 US00453660 US00453661 US00453662 US00453663 US00453664 US00453666 US00453667 US00453668 US00453669 US00453670 US00453671 US00453672 US00453673 US00453674 US00453675 US00453676 US00453677 US00453678 US00453679 US00453691 US00453692 US00453693 US00453694 US00453695 US00453696 US00453712 US00453714 US00453715 US00453716 US00453717 US00453721 US00453723 US00453724 US00453725 US00453726 US00453730 US00453731 US00453732 US00453733 US00453734 US00453735 US00453736 US00453737 US00453738 US00453739 US00453740 US00453742 US00453744 US00453745 US00453746 US00453747 US00453748 US00453749 US00453751 US00453752 US00453753 US00453754 US00453755 US00453758 US00453759 US00453760 US00453766 US00453767 US00453796 US00453797 US00453798 US00453799 US00453800 US00453801 US00453802 US00453803 US00453804 US00453805 US00453806 US00453807 US00453808 US00453809 US00453810 US00453811 US00453812 US00453813 US00453814 US00453815 US00453816 US00453817 US00453818 US00453819 US00453820 US00453821 US00453822 US00453823 US00453824 US00453825 US00453826 US00453827 US00453828 US00453829 US00453830 US00453831 US00453832 US00453833 US00453834 US00453835 US00453836 US00453847 US00453849 US00453850 US00453852 US00453853 US00453854 US00453855 US00453856 US00453857 US00453861 US00453863 US00453864 US00453865 US00453866 US00453867 US00453868 US00453869 US00453870 US00453871 US00453872 US00453873 US00453874 US00453907 US00453908 US00453909 US00453910
RECALLING FIRM/MANUFACTURER
Philips, Medical Systems, Andover, MA, by letter dated September 4, 2007. Firm initiated recall is ongoing.
REASON
Inadequate shipping package causing damage to control boards resulting in unit failure. Failure to deliver therapy (defibrillation, pacing or cardioversion) may occur as a result of undetected damage to the PCB assembly.
VOLUME OF PRODUCT IN COMMERCE
147 boards
DISTRIBUTION
Internationally
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PRODUCT
BD Microkeratome K3000 and K4000; Catalog Number: 378660, Recall # Z-0066-2008
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Becton Dickinson and Company, Waltham, MA, by letter dated August 9, 2007. Firm initiated recall is complete.
REASON
Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea.
VOLUME OF PRODUCT IN COMMERCE
256 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
a) Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA Coated Cluster Screw
Holes. Hip prosthesis component. Sterile, Made in USA, Recall # Z-0072-2008;
b) HA Solid Back Acetabular Shell; Arc Deposited HA Coated Included Dome hole
Plug; Hip prosthesis component. Sterile; made in USA, Recall # Z-0073-2008
CODE
a) Catalog # Description Lot code 542-11-46D TRIDENT PSL HA CLUSTER 46mm
R3YMHD; 542-11-48D TRIDENT PSL HA CLUSTER 48mm 1PMMJD 542-11-48D
TRIDENT PSL HA CLUSTER 48mm 663MJD 542-11-48D TRIDENT PSL HA
CLUSTER 48mm 664MJD 542-11-50E TRIDENT PSL HA CLUSTER 50mm
1TEMJD 542-11-50E TRIDENT PSL HA CLUSTER 50mm 1TJMJD 542-11-50E
TRIDENT PSL HA CLUSTER 50mm 2K0MJD 542-11-50E TRIDENT PSL HA
CLUSTER 50mm 32JMJD 542-11-50E TRIDENT PSL HA CLUSTER 50mm
61YMJD 542-11-50E TRIDENT PSL HA CLUSTER 50mm 626MJD 542-11-50E
TRIDENT PSL HA CLUSTER 50mm 70HMJD 542-11-50E TRIDENT PSL HA
CLUSTER 50mm 71NMJD 542-11-50E TRIDENT PSL HA CLUSTER 50mm
PYNMHD 542-11-50E TRIDENT PSL HA CLUSTER 50mm RHVMHD 542-11-50E
TRIDENT PSL HA CLUSTER 50mm RHXMHD 542-11-52E TRIDENT PSL HA
CLUSTER 52mm 8R8MJD 542-11-52E TRIDENT PSL HA CLUSTER 52mm
8RDMJD 542-11-52E TRIDENT PSL HA CLUSTER 52mm PYVMHD 542-11-52E
TRIDENT PSL HA CLUSTER 52mm REKMHD 542-11-54F TRIDENT PSL HA
CLUSTER 54mm 0YPMJD 542-11-54F TRIDENT PSL HA CLUSTER 54mm
3HAMJD 542-11-54F TRIDENT PSL HA CLUSTER 54mm 500MJD 542-11-54F
TRIDENT PSL HA CLUSTER 54mm 76YMJD 542-11-54F TRIDENT PSL HA
CLUSTER 54mm 7NWMJD 542-11-54F TRIDENT PSL HA CLUSTER 54mm
7Y3MJD 542-11-54F TRIDENT PSL HA CLUSTER 54mm 7Y4MJD 542-11-54F
TRIDENT PSL HA CLUSTER 54mm 8HWMJD 542-11-54F TRIDENT PSL HA
CLUSTER 54mm TK9MHD 542-11-54F TRIDENT PSL HA CLUSTER 54mm
TKAMHD 542-11-54F TRIDENT PSL HA CLUSTER 54mm TKDMHD 542-11-54F
TRIDENT PSL HA CLUSTER 54mm TKEMHD 542-11-54F TRIDENT PSL HA
CLUSTER 54mm TKHMHD 542-11-56F TRIDENT PSL HA CLUSTER 56mm
0PJMJD 542-11-56F TRIDENT PSL HA CLUSTER 56mm 0PMMJD 542-11-56F
TRIDENT PSL HA CLUSTER 56mm 81AMJD 542-11-56F TRIDENT PSL HA
CLUSTER 56mm 81DMJD 542-11-56F TRIDENT PSL HA CLUSTER 56mm
T6KMHD 542-11-58G TRIDENT PSL HA CLUSTER 58mm 518MJD 542-11-62H
TRIDENT PSL HA CLUSTER 62mm 2PMMJD 542-11-62H TRIDENT PSL HA
CLUSTER 62mm 7D2MJD 542-11-68I TRIDENT PSL HA CLUSTER 68mm
3AWMJD 542-11-72J TRIDENT PSL HA CLUSTER 72mm 1WNMJD
b) 540-11-52E TRIDENT PSL HA SOLID BACK 52mm 8NKMJD 540-11-54F
TRIDENT PSL HA SOLID BACK 54mm 3H7MJD 540-11-58G TRIDENT PSL HA
SOLID BACK 58mm 78AMJD 540-11-58G TRIDENT PSL HA SOLID BACK
58mm 9T9MJD 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 4THMJD 540-
11-66I TRIDENT PSL HA SOLID BACK 66mm 4TJMJD 540-11-66I TRIDENT
PSL HA SOLID BACK 66mm RLKMHD 540-11-72J TRIDENT PSL HA SOLID
BACK 72mm 1WNMJD
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on August 30, 2007. Firm initiated recall is ongoing.
REASON
Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one side and will decrease the gap between shell and liner on the opposing side, resulting in interference.
VOLUME OF PRODUCT IN COMMERCE
142 units
DISTRIBUTION
Nationwide and Brazil
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PRODUCT
Steris QFC1728 and QFC1729 Quick Connects;(used to connect gastrointestinal endoscopes to processing trays) The malfunctioning piece of the quick connect component is adaptor #6, STERIS part number 201158. Adaptor #6 attaches to the suction port of the endoscope., Recall # Z-0101-2008
CODE
C041782, C041793, 3072287, C041514, C041512, C041508, C041513, C041515, 3072303, 3290749, 3338126, C041781, C041794, 3072246, C041506, C041509, C041510, C041511, 3072261, 3290723, 3318292, 3338100, 3352374, 3542412, 3643871, 3546157, 3656121, 3893160, 3890027, 3748456, 3930062, 3978731, 3342342, 3352390, 3575941, 3643897, 3668357, 3895661, 3900198
RECALLING FIRM/MANUFACTURER
Steris Corporation Hopkins Facility, Mentor, OH, by telephone on September 12, 2007, and by letters on September 28, 2007. Firm initiated recall is ongoing.
REASON
Loose or missing adaptor. The center insert of the adaptor #6 restrictor could become loose and/or come out of the adaptor’s housing. The absence of adaptor #6’s center insert may affect the sterilization process of the attached endoscope.
VOLUME OF PRODUCT IN COMMERCE
391 Quick Connects
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Biomet Orthopedics Apical Hole Plug, 3/8 – 24 threaded, TI-6AL-4V alloy, sterile; REF123741, Recall # Z-0102-2008
CODE
Lot: 522080
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by telephone on August 9, 2007 and by letter dated August 31, 2007. Firm initiated recall is complete.
REASON
Incorrect or lack of threading: The plug component was manufactured incorrectly and does not fit with the screw hole as intended.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
MA
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PRODUCT
a) Boston Scientific mach 1 Guide Catheter, 8F, FCL 3.5 SH Femoral Curve Left 3.5,
REF 34358-268, UPN H749343582680, Sterile EO, Recall # Z-0103-2008;
b) Boston Scientific mach 1 Guide Catheter, VL3.5 SH Voda Left 3.5, REF 34358-78,
UPN H74934358780, Sterile EO, Made in Mexico, Recall # Z-0104-2008
CODE
a) Lot #: 572191;
b) Lot #: 559022
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific, Maple Grove, MN, by telephone, interoffice memo and letter on September 11, 2007.
Manufacturer: Pacific Device De Mexico S A De C V, Tijuana B C, Mexico. Firm initiated recall is ongoing.
REASON
Missing holes: Catheters are missing the catheter's side holes.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
NY, PA, and Japan
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES - CLASS I
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PRODUCT
a) Krasdale brand Gravy Dog Food in 5 lb bags. The product is shipped 10 bags per
bale/20 bales pr pallet; UPC 75130 62596, Recall # V-001-2008;
b) PMI Nutrition Red Flannel brand Large Breed Adult Formula Dog Food in 50 lb
bags. The product is shipped 20 bags per pallet; UPC number 42869 00062,
Recall # V-002-2008
CODE
a) Best By Jul 16 08 17 (military time) 1;
b) Best by Jul 12 08 17 (military time) 1
RECALLING FIRM/MANUFACTURER
Mars Pet Care Company, Everson, PA, by telephone and press release on August 22, 2007.
Firm initiated recall is complete.
REASON
Positive for Salmonella spp. Poly A. Serotype pending.
VOLUME OF PRODUCT IN COMMERCE
1,623 bags
DISTRIBUTION
CT, MA, NJ, NY, and PA
___________________________________
PRODUCT
a) Dick Van Patten's Natural Balance Eatables for Dogs; Irish Stew With Beef,
Potatoes & Carrots; 15 oz can; UPC 2363359860, Recall # V-003-2008;
b) Dick Van Patten's Natural Balance Eatables for Dogs; Chinese Take Out With Sauce
With Vegetables and Chicken; 15 oz can; UPC 2363359861, Recall # V-004-2008;
c) Dick Van Patten's Natural Balance Eatables for Dogs; HOBO Chili with Chicken &
Pasta;15oz can; UPC 23633 59863, Recall # V-005-2008;
d) Dick Van Patten's Natural Balance Eatables for Dogs; Southern Style Dumplings
With Chicken & Vegetables; 15oz can; UPC 23634 59862, Recall # V-006-2008
CODE
All best by and code dates
RECALLING FIRM/MANUFACTURER
Castleberry’s Food Company, Augusta, GA, by press releases on July 18, July 21, and August 1, 2007 and by telephone, emails, and letters starting on July 18, and July 22, 2007, and by visits starting on August 24, 2007. Firm initiated recall is ongoing.
REASON
This recall was initiated due to possible contamination with Clostridium botulinum.
VOLUME OF PRODUCT IN COMMERCE
114,779 cases (1,377,348 cans)
DISTRIBUTION
Nationwide, Canada, Japan, and South Korea
___________________________________
PRODUCT
a) Bravo Original Formula Chicken Blend frozen raw food Product Numbers: 21-102,
21-105, 21-110 Sizes: 2 pound, 5 pound and 10 pound tubes, Recall # V-007-2008;
b) Bravo Original Formula Turkey Blend frozen raw food Product Numbers: 31-102,
31-105, 31-110 Sizes: 2 pound, 5 pound and 10 pound tubes Batch ID code (on hang
tag): 236, Recall # V-008-2008;
c) Bravo Basic Formula Finely Ground Chicken frozen raw food Product Number: 21-
212, Size: 2 pound tube, Recall # V-009-2008
CODE
Batch ID code (on hang tag): 236
RECALLING FIRM/MANUFACTURER
Recalling Firm: BRAVO! LLC, Vernon, CT, by email on September 19, 2007.
Manufacturer: Manchester Packing Company, Manchester, CT. Firm initiated recall is ongoing.
REASON
Raw Diet Dog and Cat food contaminated with Samonella and/or Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
18,000 lbs
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR OCTOBER 31, 2007
#
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
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PRODUCT
a) Medtronic Sprint Fidelis 6930 Steroid eluting, tripolar, ventricular lead with tined tip
and right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed
for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0067-2008;
b) Medtronic Sprint Fidelis 6931 Steroid eluting, tripolar, screw-in, ventricular lead
with right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed
for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0068-2008;
c) Medtronic Sprint Fidelis 6948 Steroid eluting, quadripolar, ventricular lead with tined
tip and right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil
electrodes. Sterile. This lead is designed for pacing, sensing, cardioversion and
defibrillation therapies, Recall # Z-0069-2008;
d) Medtronic Sprint Fidelis 6949 Steroid eluting, quadripolar, screw-in, ventricular lead
with right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes.
Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation
therapies, Recall # Z-0070-2008
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic, Inc., Rhythm Management, Minneapolis, MN, by press release, FDA Statement and letter dated October 15, 2007.
Manufacturer: Medtronic Puerto Rico, Inc., Villalba Pr, PR. Firm initiated recall is ongoing.
REASON
Medtronic Cardiac Rhythm Disease Management has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949). Medtronic, its Independent Physician Quality Panel, and Bruce Lindsay, M.D., Professor of Medicine, Director of Cardiac Electrophysiology, Washington University School of Medicine and the President of the Heart Rhythm Society (HRS), do not recommend that patients seek prophylactic replacement of Sprint Fidelis leads, as the risks of removal or insertion of another lead exceed the small risk to patients of a lead fracture. Medtronic has provided patient management recommendations that should reduce risks in the affected population and recommends that patients with questions consult their physicians. Information is also available for patients and physicians at www.medtronic.com/fidelis. This decision is based on a variety of factors that, when viewed together, indicate that suspending distribution is the appropriate action. Lead fractures may present clinically as audible alerts, inappropriate shocks and/or loss of output.
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