April 17, 2002 02-15
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________ PRODUCT Texturized wheat protein products packaged in 10-lb, 15-lb., 17-lb., 25-lb., and 3.5-kg. bags for use in further manufacture. The products are: a) Wheatex 20 Pro 0122-TP122 Textured Wheat Protein, 15-lb. and 17-lb bags and Wheatex 6000, 10-lb., 15-lb. and 17-lb. bags. Recall # F-364-2. b) Wheatex 6000C, 15-lb. bags. Recall # F-365-2; c) Wheatex 4000, 25-lb. bags. Recall # F-366-2; d) Wheatex 3000 (also called Textured Protein Substance 3000), 3.5-kg. bags. Recall # F-367-2; e) Scott Adams Foods Saf-Cube-EPC Textured Wheat Protein 25-lb. bags and Wheatex Cube, 25-lb. bags. Recall 3 F-368-2. (Note: Products #1 and 5 have two different names, but they have the same formulation.) CODE a) Wheatex 20 Pro 0122-TP122 Textured Wheat Protein 505-10-00258, exp. 7/31/01 011-11-00325, exp. 11/20/01 505-07-00222, exp. 8/9/01 Wheatex 6000 011-13-01002, exp. 1/2/02 011-14-01008, exp. 1/8/02 011-08-00269, exp. 9/25/01 011-09-00311, exp. 11/6/01 011-10-00318, exp. 11/11/01 011-05-00221, exp. 8/8/01 011-01-99307, exp. 11/3/00 011-06-00229, exp. 8/6/01 505-06-00125, exp. 5/4/01 011-11-00325, exp. 11/20/01 b) Wheatex 6000C 045-01-01169, exp. 6/18/02 c) Wheatex 4000 036-07-01079, exp. 3/20/02 036-07-01029, exp. 1/29/02 d) Wheatex 3000 (also called Textured Protein Substance 3000 506T-06-00171, exp. 6/19/01 506T-06-00171B, exp. 6/19/01 506T-03-99288, exp. 9/15/00 506T-05-00077, exp. 3/17/01 e) Scott Adams Foods Saf-Cube-EPC Textured Wheat Protein 014-02-00174, exp. 6/22/01 Wheatex Cube 014-06-00327, exp. 11/22/01 014-03-00220, exp. 8/7/01 014-04-00293, exp. 9/19/01 014-02-00174, exp. 06/22/01. RECALLING FIRM/MANUFACTURER Recalling Firm: Midwest Grain Products, Inc., Atchison, KS, by letters on August 10, 2001. Manufacturer: Kansas City Ingredient Technologies, Inc., Kansas City, KS. (Note: Prior to 2/2001, the manufacturer was the recalling firm.) Firm initiated recall is complete. REASON The products contained undeclared sulfites. VOLUME OF PRODUCT IN COMMERCE a) Wheatex 20 Pro 0122-TP122 Textured Wheat Protein, 8 15-lb. bags and 100 17-lb. bags and Wheatex 6000, 393 10-lb. bags, 6,954 15-lb. bags, and 951 17- lb. bags; b) Wheatex 6000C, 104 15-lb. bags; c) Wheatex 4000, 106 25-lb. bags; d) Wheatex 3000 (also called Textured Protein Substance 3000), 12,018 3.5-kg. bags; e) Scott Adams Foods Saf-Cube-EPC Textured Wheat Protein, 282 25-lb. bags and Wheatex Cube, 282 25-lb. bags. DISTRIBUTION CA, PA, CT, NY, FL, UT, WI, and MA and Canada, Malaysia, Philipines, Taiwan, and China.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________ PRODUCT Assorted individually wrapped candies in 9 oz. plastic bag labeled in part "MOUNTAIN GEMS KIDDIE TREATS. Recall # F-369-2. CODE Product is not coded. RECALLING FIRM/MANUFACTURER Gem State Distributors, Inc., Pocatello, ID, by telephone on March 22, 2002. FDA initiated recall is complete. REASON The product contained undeclared FD&C Yellow No. 5. VOLUME OF PRODUCT IN COMMERCE Approx. 143/9 oz. Bags. DISTRIBUTION ID, UT and WY. _______________________ PRODUCT Cameron's Confections Premium brand of White Cheddar Gourmet Popcorn, packaged in 2 ounce plastic bags. Recall # F-373-2. CODE 012802-3. RECALLING FIRM/MANUFACTURER Ace Adjustment Service, Parkersburg, WV, by telephone on January 31, 2001. Firm initiated recall is complete. REASON Product contains undeclared FD&C Yellow No. 5 and FD&C Yellow No. 6. VOLUME OF PRODUCT IN COMMERCE 75 bags. DISTRIBUTION UT. _______________________ PRODUCT Betty Crocker Suddenly Pasta Salad, Italian Garden, Net Weight 6.8 ounces, labeled "Made in Australia.” Recall # F-375-2. CODE Better if use by dates of 01 SEP 02 through 30 NOV 02. RECALLING FIRM/MANUFACTURER Recalling Firm: General Mills, Inc. Golden Valley, MN, by notice on January 4, 2002. Manufacturer: Mansfields PTY LTD., Keysborough, Victoria. Firm initiated recall is complete. REASON The products had incorrectly been labeled with labels intended for the firm's Australian customers. The Australian label lists FD&C Yellow No. 5 as tartrazine and FD&C Yellow Number 6 as Sunset Yellow. VOLUME OF PRODUCT IN COMMERCE 5084 cases (6 retail units/case). DISTRIBUTION AL, CA, OH and PA. _______________________ PRODUCT Honey Maid Graham Cracker Crumbs in 25 lb. bulk boxes, which are unlabeled except for a tag identifying the contents as product #00777. Recall # F-376-2. CODE Product was not coded. RECALLING FIRM/MANUFACTURER Recalling Firm: Kraft Foods, Inc., Northfield, IL, by letter on November 7, 2001. Manufacturer: Nabisco, Atlanta, GA. Firm initiated recall is complete. REASON Product does not bear an ingredient statement and contains wheat as an ingredient. VOLUME OF PRODUCT IN COMMERCE 1,123 boxes. DISTRIBUTION CO, FL, GA, MD, MI, MN, NJ, PA, SC and TN.RECALLS AND FIELD CORRECTIOS: FOODS -- CLASS III
_______________________ PRODUCT The product comes in two different sizes. The 5 oz. container states in part: "TRES LECHES THREE CREAM CAKE LILA'S DESSERTS", packed in a clear plastic cup with yellow, red, green, and black markings. The brown cardboard shipping carton states in part: "USE BEFORE LILA'S 24 - 5 OZ. CREAM CAKE (TRES LECHES)***KEEP REFRIGERATED***." The 20 oz. container states in part: "LILA'S DESSERTS TRES LECHES THREE CREAM CAKE", packed in hinged clear plastic container with the yellow, red, black, and blue label on the top. The brown cardboard shipping carton states in part: "USE BEFORE EXP *** LILA'S TRES LECHE KEEP REFRIGERATED*** 12/20 OZ. TRES LECHE." Recall # F-370-2. CODE Product is not coded. RECALLING FIRM/MANUFACTURER Lila's Desserts, Inc., Miami, FL, by visits beginning August 20, 2002. FDA initiated recall is complete. REASON The product contained undeclared FD&C Red No. 40. VOLUME OF PRODUCT IN COMMERCE 224 cases of the 5 oz cups and 180 cases of the 20 oz cups. DISTRIBUTION FL. _______________________ PRODUCT Happy Harvest Grade A Early Small Peas; Net Wt. 15 Oz. can, 24 cans per case; UPC #41498-12067. Recall # F-371-2. CODE PB9SH/36291 XXXX, where XXXX is the time packed. The whole day's production was recalled by the distributor; its item is #02/12540. RECALLING FIRM/MANUFACTURER Recalling Firm: Aldi, Inc., Batavia, IL, by fax on January 9, 2002. Manufacturer: Lakeside Foods, Reedsburg, WI. Firm initiated recall is complete. REASON The product was contaminated with filth (insects/insect larvae). VOLUME OF PRODUCT IN COMMERCE 15,240 cans. DISTRIBUTION OH, KY and WV. _______________________ PRODUCT Shur-Fine brand Apple Cider sold in half gallon and one gallon plastic bottles and labeled as distributed by Western Family Foods, Inc., Portland, OR. Recall # F-372-2. CODE All lots on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Mayer Brothers Apple Products, Inc., West Seneca, NY, by letter dated November 5, 2001. State initiated recall is complete. REASON The product contained undeclared potassium sorbate VOLUME OF PRODUCT IN COMMERCE Approximately 10,000 cases. DISTRIBUTION NY, PA and OH.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
______________________ PRODUCT a) Levothyroxine Sodium, USP, tablets, 25 mcg (0.025 mg) Rx Only 100 and 1,000 count bottles. Recall # D-231-2. b) Levothyroxine Sodium, USP, tablets, 50 mcg (0.05 mg) Rx Only 100 and 1,000 count bottles. Recall # D-232-2. Both strengths are sold under the Vintage, Qualitest and URL brand labels. CODE a) Levothyroxine Sodium 0.025 mg 042040A, 042040B, 042040C, 042040D, 042040E, 020030A, 020030B, 041040A, 041040B, 041040C; b) Levothyroxine Sodium 0.05 mg 004129C, 004129D, 004129E. RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte, NC, by letter on November 8, 2000. Firm initiated recall is complete. REASON Stability; Inability to maintain potency throughout the labeled expiration date. VOLUME OF PRODUCT IN COMMERCE a) 15,795 bottles 0.025 mg size; b) 13,043 bottles 0.05 mg size. DISTRIBUTION AL.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT Calcijex, Calcitriol Injection, For I.V. use,1 mcg/mL single dose ampul, Rx Only. Recall # D-230-2. CODE Lot No. 85-305-DK, Exp Date May 1, 2003 NDC 0074-8110-31. RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Laboratories, Abbott Park, IL, by letter on March 7, 2002. Manufacturer: Abott Laboratories, Rocky Mount, NC. Firm initiated recall is ongoing. REASON Mispackaging: Vitamin K1 Injection found in a box of Calcijex injection. VOLUME OF PRODUCT IN COMMERCE 126,075 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Paclitaxel Injection, 6 mg/ml, packaged in 5 ml, 16.7ml, and 50 ml Multiple-Dose vials, Rx only. Recall # D-233-2. CODE Lot Numbers/Expiration Dates: #271220, Exp. June 2003; #236135, Exp. June 2003; #236137, Exp. July 2003; #323242, Exp. Aug 2003; #271224, Exp. Aug 2003; #271225, Exp. Aug 2003; #271226, Exp. Aug 2003; #271227, Exp. Sept 2003. RECALLING FIRM/MANUFACTURER Recalling Firm: Ben Venue Laboratories, Inc., Bedford, OH, by letters on March 5, 2002. Firm initiated recall is ongoing. REASON Impurity levels are exceeding specifications (during stability testing). VOLUME OF PRODUCT IN COMMERCE 33,216 vials. DISTRIBUTION Nationwide and Puerto Rico. _______________________ PRODUCT HAND MEDIC Antiseptic Skin Treatment, OTC, packaged in 500 ml cartridges, and 2 oz, 4 oz, and 8 oz bottles. Active ingredient: Benzalkonium Chloride 0.1%. Recall # D-237-2. The 500 ml cartridges are sealed poly bags inside a rectangular cardboard box, 6 per case. All bottles are black plastic, 12 per case (2 oz & 4 oz bottles), or 6 per case (8 oz bottles). The 500 ml cartridges, and the 4 oz and 8 oz bottles are packaged under the GOJO brand label; and the 2 oz bottles are packaged under either the GOJO brand or Pro-Link brand labels. The product catalog numbers are as follows: #8242-06 (500 ml cartridges); #8142-12 (2 oz); #8147-12 (4 oz). #8145-06 (8 oz) CODE Lot Numbers: 165461, 166095, 166581, 166826, 167503, 168453, and 168912. RECALLING FIRM/MANUFACTURER GOJO Industries, Inc., Cuyahoga Falls, OH, by fax on March 26, 2002. Firm initiated recall is ongoing. REASON Superpotency of the active ingredient (Benzalkonium Chloride). VOLUME OF PRODUCT IN COMMERCE 9,703 cases. DISTRIBUTION Nationwide. _______________________ PRODUCT PROVON Medicated Lotion Soap with Triclosan, OTC, packaged in 12 fl. oz. white plastic bottles. Active ingredient: Triclosan 0.3%, Product Number 4153-12. The bottles are packaged under the GOJO brand label. Recall # D–238-2. A case contains 12-12 fl oz bottles with a pump closure in cardboard box. CODE Lots #169738 and #168862. RECALLING FIRM/MANUFACTURER GOJO Industries, Inc., Cuyahoga Falls, OH, by fax on March 29, 2002. Firm initiated recall is ongoing. REASON Misbranding: Back bottle label declares incorrect active ingredient. VOLUME OF PRODUCT IN COMMERCE 37 cases. DISTRIBUTION WI, IL, WA, MO, NE, LA, MA, and CA.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT a) Red Blood Cells, Recall # B-0976-2; b) Recovered Plasma, Recall #B-0977-2. CODE a) Unit numbers 15005-5707, 15007-7758, 15010-6106, and 15012-0471; b) Unit numbers 15007-7758 and 15010-6106. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Lubbock, TX, by letter dated May 9, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an unsuitable donor based previous repeatedly reactive testing for anti-HCV, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION TX, CA and NY. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0982-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-0983-2; c) Fresh Frozen Plasma, Recall # B-0984-2. CODE a) Unit Numbers: 53FE38703, 53FE38710, 53FE38712, 53GF14940, 53GF14941, 53GF14943, 53GF15017, 53GF15018, 53GF15019, 53GF15020, 53GF15021, 53GF15022, 53GF15023, 53GF15024, 53GF15043, 53GF15044, 53GF15045, 53GF15048, 53GF15049, 53GF15063, 53GF15064, 53GF15065, 53GF15066, 53GF15067, 53GF15068, 53GF15087, 53GF15088, 53GF15089, 53GF15090, 53GF15091, 53GF15092, 53GF15132, 53GF15133, 53GF15134, 53L95008, 53L95009, 53L95010, 53L95011, 53L95012, 53FL61648, 53FL61649, 53FL61650, 53FL61651, 53FL61652, 53FL61654, 53FL61655, 53FL61656, 53FL61657, 53FL61658, 53FL61659, 53FL61660, 53FL61662, 53FL61663, 53FL61664, 53FL61665, 53FL61666, 53FL61667, 53FL61668, 53FL61669, 53FL61670, 53FL61671, 53FK40381, 53FK40384, 53FK40385, 53FP11665, 53FP11666, 53FP11667, 53FP11668, 53FL61814, 53FL61834, 53FL61836, 53FL61837, 53FJ43839, 53FJ43840, 53FJ43841, 53FJ43842, 53FJ43843, 53FJ43844, 53FJ43845, 53FJ43847, 53FJ43848, 53FJ43849, 53FJ43850, 53FJ43852, 53FJ43853, 53FJ43854, 53FJ43855, 53FJ43856, 53FJ43857, 53FJ43858, 53FJ43859, 53FJ43860, 53FJ43861, 53FJ43862, 53FJ43863, 53FJ43864, 53FJ43865, 53FJ43867, 53GV21812, 53FJ43905, 53GR10346, 53GR10347, 53Y67539, 53Y67540, 53Y67576, 53Y67577, 53GV21496, 53GV21497, 53GV21498, 53GV21499, 53GV21500, 53GV21501, 53GV21502, 53GV21503, 53GV21504, 53GV21505, 53GV21506, 53GV21510, 53GV21526, 53GV21527, 53FP11410, 53FM16938, 53FM16939, 53FM16940, 53FM16941, 53M68875, 53M68876, 53M68877, 53M68878, 53M68879, 53M68880, 53FN36829, 53FN36832, 53FJ43517, 53FJ43518, 53FJ43519, 53FJ43520, 53FJ43521, 53FJ43522, 53FJ43531, 53FJ43532, 53FJ43533, 53FJ43534, 53FJ43535, 53FJ43536, 53FJ43537, 53FJ43538, 53FJ43539, 53FJ43541, 53FJ43542, 53FJ43543, 53FJ43544, 53FJ43545, 53FJ43546, 53FJ43553, 53FJ43554, 53FJ43555, 53FJ43602, 53FJ43603, 53FJ43604, 53GQ55535, 53T44878, 53T44879, 53GC08568, 53GL88735, 53GL88740, 53GL88742, 53GL88745, 53GL88746, 53GL88747, 53GC08566, 53GC08569, 53GC08572, 53GC08573, 53GC08574, 53FE37524, 53Z17569, 53Z17570, 53Z17571, 53Z17572, 53Z17573, 53Z17574, 53FL60442, 53FL60443, 53FL60445, 53LL27415, 53LL27416, 53LL27417, 53LL27418, 53LL27419, 53LL27420, 53LL27421, 53LL27425, 53LL27426, 53FJ41836, 53FJ41837, 53FJ41838, 53FJ41839, 53FJ41840, 53FJ41841, 53FJ41842, 53FJ41843, 53FJ41844, 53FJ41857, 53FJ41858, 53FJ41859, 53FJ41860, 53FJ41861, 53FJ41862, 53FJ41863, 53FJ41864, 53FJ41865, 53FJ41866, 53FJ41867, 53FJ41868, 53FJ41869, 53FJ41870, 53FJ41871, 53FJ41872, 53FJ41873, 53FJ41874, 53FJ41875, 53FJ41876; b) Unit numbers 53GF14939, 53GF14942, 53Y67541, 53Y67575; c) Unit numbers 53GF15022, 53GF15043, 53GF15047, 53GF15063, 53FJ43862, 53GV21498, 53GV21500, 53M68875, 53FJ43532, 53GC08568, 53GL88742, 53GC08569, 53LL27422, 53FJ41842, 53FJ41859, 53FJ43847, 53FN36829. RECALLING FIRM/MANUFACTURER American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone, fax and letters between February 24 and June 5, 1997. Firm initiated recall is complete. REASON Blood products, that were produced from 500 ml units of Whole Blood that were collected in 450 ml bags, were distributed. VOLUME OF PRODUCT IN COMMERCE 237 units. DISTRIBUTION MD, VA, DC, PA, GA and Puerto Rico. _______________________ PRODUCT a) Platelets, Pheresis, Recall # B-1032-2; b) Platelets, Pheresis, Leukocytes Reduced, Recall # B-1033-2. CODE a) Unit 7415061, 7415078, 7304965-1, 7304965-2; b) Unit 7415111, 7415169, 7415285. RECALLING FIRM/MANUFACTURER Manatee Community Blood Centers, Inc., Bradenton, FL, by telephone and fax on March 13, 2001. Firm initiated recall is complete. REASON Platelets, that exceeded the manufacturer’s recommendation for platelet count, were distributed. VOLUME OF PRODUCT IN COMMERCE 7 units. DISTRIBUTION FL, NY and PA. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1035-2. b) Platelets, Leukocytes Reduced, Recall # B-1036-2. CODE a) and b) Unit 42T01458. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH, by letter dated January 30, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor who reported living in an area designated as endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OH. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1037-2. CODE Units 12V00572, 12FV05927. RECALLING FIRM/MANUFACTURER American Red Cross, Carolina Region, Charlotte, NC, by letter dated July 30, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who reported living in an area designated as endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NC. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1039-2 b) Platelets, Recall # B-1040-2. CODE a) Units 1648370, 1684408; b) Unit 1684408. RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Lexington, KY, by letter dated January 24, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION KY. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1066-2. CODE Unit number 10625-5145. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on August 3 and by letter dated August 31, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor that tested positive for the S red blood cell antigen, but was incorrectly labeled as negative for the S antigen, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION TX. _______________________ PRODUCT Fresh Frozen Plasma, Recall # B-1067-2. CODE Unit number GX37405. RECALLING FIRM/MANUFACTURER Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by letter dated June 29, 2001. Firm initiated recall is complete. REASON Blood product, that contained type A1 red blood cell antibodies, but was incorrectly labeled negative for unexpected red blood cell antibodies, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Corneas, Recall # B-1069-2. CODE Tissue numbers 0878-01-01 and 0878-01-02. RECALLING FIRM/MANUFACTURER North Carolina Eye Bank, Inc., Winston-Salem, NC, by telephone on September 12, 2001. Firm initiated recall is complete. REASON Human tissue for transplantation, that tested negative for hepatitis B surface antigen (HBsAg) prior to distribution, but was subsequently found to test repeatedly reactive for HBsAg by a different facility, was distributed. VOLUME OF PRODUCT IN COMMERCE 2 tissues. DISTRIBUTION NC. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1070-2; b) Recovered Plasma, Recall # B-1071-2. CODE a) and b) Unit number 33GS18055. RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut Region, Farmington, CT, by letters on January 15 and 24, 2002. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from a donor who did not properly use the confidential unit exclusion form to indicate whether the blood should be used, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CT and CA. _______________________ PRODUCT a) Red Blood Cells, Recall #B-1072-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-1073-2; c) Platelets, Recall # B-1074-2; d) Cryoprecipitated AHF, Recall # B-1075-2; e) Plasma, Recall # B-1076-2; f) Fresh Frozen Plasma, Recall # B-1077-2; g) Red Blood Cells for manufacture, Recall # B-1078-2; h) Platelets for further manufacture, Recall # B-1079-2; i) Recovered Plasma, Recall #B-1080-2. CODE a) Unit numbers 03FC21146, 03R69497, 03N96584, 03C46789, 03FF17322, 03T98220, 03LT14024, 03Z24894, 03FT20023, 03R77504, 03S76260, 03FL23346, 03FC23974, 03FC30331, 03GH14032, 03T79687, 03LM10438, 03Z18650, 03FL36201, 03H68994, 03K44287, 03W90783, 03W93508, 03N63027, 03T46796, 03M06999, 03M09671, 03Z68091, 03J56160, 03Z73586, 03Y93096, 03T63180, 03J69118, 03V70987, 03G18811, 03V75182, 03T75714, 03L72961, 03FJ16150, 03X17103, 03M47110, 03L80586, 03K01104, 03LM18530, 03V97209, 03V99258, 03V01048, 03GJ01020, 03M65840, 03GJ10161, 03FJ31632,03GJ13571, 03LM38995, 03GQ02360, 03X18906, 03L85014, 03V98458, 03C56030, 03GF13805, 03FL35407, 03GR01813,03FW28493, 03Z97893, 03V87494, 03L82189, 03FL17796,03Z20294, 03GM00321, 03FT21461, 03G24500, 03M44447, 03LM22485, 03LM29265, 03Z11922, 03FC21368, 03GT03177,03FV27977, 03GW20264, 03GT44586, 03FC53849, 03GZ12080,03GR41231, 03LR45162, 03GL21436, 03GM15379, 03LR35296,03GT09723, 03FL54233, 03GT17584, 03GR10206, 03FR27234,03GR05149, 03FW30585, 03GQ11910, 03FV30741, 03FC39304,03FQ08247, 03FQ08867, 03GT31147, 03FQ10359, and 03GP35619; b) Unit numbers 03GH03824, 03FV67010, 03GK54256, 03LR59870, 03FR35022, 03FL70080, 03GZ06328, 03FR37720, 03GM29786, 03LM60236, 03GY05263, 03GS21885, 03GZ15405, and 03FQ16570; c) Unit numbers 03R69497, 03N96584, 03C46789, 03FF17322, 03Z24894, 03LM10438, 03FL36201, 03J23990, 03K44287, 03W90783, 03W93508, 03N63027, 03T46796, 03M06999, 03M09671, 03J56160, 03Z73586, 03Y93096, 03J69118, 03V70987, 03V75182, 03T75714, 03L72961, 03FJ16150, 03X17103, 03M47110, 03L80586, 03GJ01020, 03M65840, 03L85014, 03V87494, 03G24500, 03LM22485, 03LM29265 03Z11922, 03GH03824, 03GT03177, 03FV27977, 03FL54233, and 03V01048; d) Unit number 03GT31147; e) Unit number 03FQ16570; f) Unit numbers 03C46789, 03T98220, 03LT14024, 03FL36201, 03W90783, 03W93508, 03N63027, 03M06999, 03M09671, 03Z73586, 03T75714, 03FJ16150, 03M47110, 03V01048, 03GJ01020,03FJ31632, 03GJ13571, 03G24500, 03Z11922, 03GT03177, 03FL70080, and 03FL54233; g) Unit numbers 03N01102 and 03LM16409; h) Unit numbers 03T79687, 03Z68091, 03V97209, 03V99258, and 03FJ31632; i) Unit numbers 03FC21146, 03R69497, 03N96584, 03N01102, 03FF17322, 03Z24894, 03FT20023, 03S76260, 03FL23346, 03FC23974, 03FC30331, 03GH14032, 03T79687, 03LM10438, 03J23990, 03K44287, 03T46796, 03Z68091, 03T63180, 03J69118, 03V70987, 03V75182, 03L72961, 03X17103, 03L80586, 03K01104, 03LM18530, 03V97209, 03V99258, 03M65840, 03GJ10161, 03LM38995, 03GQ02360, 03X18906, 03L85014, 03V98458, 03C56030, 03GF13805, 03FL35407, 03GR01813, 03FW28493, 03Z97893, 03V87494, 03L82189, 03FL17796, 03Z20294, 03GM00321, 03FT21461, 03M44447, 03LM22485, 03LM29265, 03FC21368, 03GH03824, 03FV67010, 03GK54256, 03LR59870, 03GW20264, 03GT44586, 03FC53849, 03GZ12080, 03LM60236, 03GL21436, 03GM15379, 03LR35296, 03GT09723, 03FR27234, 03GY05263, 03FW30585, 03GQ11910, 03FC39304, 03GS21885, 03FQ08247, 03FQ08867, 03FQ10359, 03GZ15405, 03GP35619, 03H68994, 03GT31147, 03FV27977, 03GT17584, 03GR05149, and 03Y93096. RECALLING FIRM/MANUFACTURER The American National Red Cross, Southern Region, Atlanta, GA, by letters on November 1, December 7 and 13, 2000 and January 13 and 14, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for the antibody to human immunodeficiency virus (anti-HIV), but were collected from donors that previously tested repeatedly reactive for anti-HIV, were distributed. VOLUME OF PRODUCT IN COMMERCE 268 units. DISTRIBUTION GA, FL, CA and Switzerland.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Source Plasma, Recall # B-1064-2. CODE Unit numbers H-15711-002, H-15712-002, H-15713-002, H-15714-002, H-15715- 002, H-15709-002, H-15716-002, and H-15720-002. RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corp., City of Industry, CA, by e-mail on June 28, 2001. Firm initiated recall is complete. REASON Source Plasma, that was exposed to unacceptable storage temperatures and was not properly relabeled as Source Plasma, Salvaged, was distributed. VOLUME OF PRODUCT IN COMMERCE 8 units. DISTRIBUTION Sweden. _______________________ PRODUCT Fresh Frozen Plasma, Recall # B-1065-2. CODE Unit number 10714-9579. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on August 13, 2001 and by letter dated September 7, 2001. Firm initiated recall is complete. REASON Blood product, exposed to potentially unacceptable temperatures during storage, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AZ. _______________________ PRODUCT Sclera, Recall # B-1068-2. CODE Tissue numbers SC-01-12-015 R2 and SC-01-12-015 L2. RECALLING FIRM/MANUFACTURER South Carolina Lions Eye Bank, Inc., West Columbia, SC, by telephone on December 12, 2001. Firm initiated recall is complete. REASON Human tissue for transplantation was distributed prior to the receipt of viral marker test results. VOLUME OF PRODUCT IN COMMERCE 2 tissues. DISTRIBUTION SC.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
_______________________ PRODUCT Various OB/GYN surgical devices labeled as sterile or processed by ETO. Recall # Z-0597-2. CODE All lots labeled as sterile RECALLING FIRM/MANUFACTURER A & A Medical/Rocket USA, (also labeled Lifequest), Alpharetta, GA, by letter on March 13, 2002. Firm initiated recall is ongoing. REASON Devices may not have been adequately sterilized. VOLUME OF PRODUCT IN COMMERCE Unknown at this time. DISTRIBUTION Nationwide, worldwide. _______________________ PRODUCT Bard RapidFire Multiple Band Ligator. Recall # Z-0755-2. CODE Bard RapidFire Multiple Band Ligator Item Number: 000608 70 Lots: 88BL0653 88BL0654 88BL0618 88BL0623 88CL0220 88CL0224 88CL0229 88CL0488 88CL0489 88CL0868 88DL0139 88DL0331 88DL0339 88DL0410 88DL0430 88DL0494 88DL0744 88DL0955 88EL0163 88EL0359 88EL0376 88EL0459 88EL0524 88EL0555 88EL0769 88EL1012 88EL1004 88FL0158 88FL0267 88FL0373 88FL0453 88FL0491 88FL0510 88FL0652 88FL0996 88GL0036 88GL0076 88GL0352 88GL0382 88GL0493 88GL0847 88HL0070 88HL0298 88HL0372 88HL0454 88HL0504 88HL0552 88HL0645 88HL0827 88HL0974 88IL0001 88IL0215 88IL0288 88IL0391 88IL0407 88IL0466 88JL0043 88JL0268 88JL0373 88JL0439 88JL0494 88JL0545 88JL0600 88JL0890 88JL0975 88KL0108 88KL0317 88KL0387 88KL0408 88LL0208. RECALLING FIRM/MANUFACTURER Recalling Firm: Bard Endscopic Technologies, Division C.R.Bard, Inc., Billerica, MA, by certified mail on January 31, 2002. Manufacturer: Proximal Inc., Largo, FL. Firm initiated recall is ongoing. REASON Band Ligator may fail to deploy and prevent control of bleeding. VOLUME OF PRODUCT IN COMMERCE 12,206 units. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________ PRODUCT PROSORBA Protein A Immunoadsorption Column - indicated for use in the therapeutic removal of immunoglobulin G (IgG) and IgG- containing circulating immune complexes from plasma in patients with idiopathic thromocytopenic purpura (ITP) having patelet counts less than 100,00mm3. The Prosorba column is indicated for use in the therapeutic reduction of the signs and symptoms of moderate to severe rheumatoid arthritis in adult patients with long standing disease who have failed or are intolerant to disease-modifying anti-rheumatic drugs (DMARDS). Recall # Z-0782-2. CODE Lot No. Expiration Date E022801 2002-02 E051501 2002-05 MGN001 2002-07 MGN002 2002-08 MMN001 2002-11. RECALLING FIRM/MANUFACTURER Fresenius Hemocare, Inc., Redmond, WA, by letters dated September 20, 2001. Firm initiated recall is complete. REASON Increased potential to develop vasculitis. VOLUME OF PRODUCT IN COMMERCE 1737 columns distributed that are still within date. DISTRIBUTION Nationwide and Wendel and Hong Kong. _______________________ PRODUCT a) ORTHOARTS Lower Extremity Drape, Bulk Pack, Non-sterile; b) ORTHOARTS Lower Extremity Drape, Sterile; c) ORTHOARTS Lower Extremity Pack, Sterile; d) ORTHOARTS Hip Drape, Bulk Pack, Non-sterile; e) ORTHOARTS Hip Drape, Sterile; f) ORTHOARTS Hip Pack, Sterile; g) ORTHOARTS Knee Arthroscopy Drape, bulk, non-sterile; h) ORTHOARTS Knee Arthroscopy Drape, sterile; i) ORTHOARTS Knee Arthroscopy Pack; j) Canton-Potsdam Lower Extremity Pack; k) Mercer Orthopedic II Pack; l) ORTHOARTS Lower Extremity Pack; m) Sharon Regional Total Knee Pack. Recall # Z-0784-2/Z-0796-2. CODE a) Lower Extremity Drape, Bulk Pack Non-sterile - Cat. No. 79278-10 - Lots 0311C01, 0311C02, 0321C01, 0321C02, 0381C01, 0381C02, 0381C03, 0381C04, 0381C05, 0381C06, 0381C07, 0431C01, 0431C02, 0431C03, 0431C04, 0431C05, 0431C06, 0441C01, 0441C02, 0441C03, 0501C01, 0501C02, 0501C03, 0501C04, 0501C05, 0501C06, 0501C07, 0501C08, 0571C01, 0571C02, 0571C03, 0571C04, 0571C05, 0571C06, 0571C07, 0571C08, 0571C09, 0641C01, 0641C02, 0641C03, 0641C04, 0641C05, 0641C06, 0641C07, 0641C08, 0641C09, 0711C01, 0711C02, 0711C03, 0711C04, 0711C05, 0711C06, 0711C07, 0711C08, 0711C09, 0781C01, 0781C02, 0781C03, 0791C01, 0791C02, 0791C03, 0791C04, 0851C01, 0851C02, 0851C03, 0851C04, 0851C05, 0851C06, 0851C07, 0851C08, 0851C09, 0941C01, 0941C02, 0941C03, 0941C04, 0951C01, 1071C01, 1071C02, 1071C03, 1071C04, 1131C01, 1131C02, 1131C03, 1131C04, 1131C05, 1131C06, 1131C07, 1141C01, 1141C02, 1211C01, 1211C02, 1211C03, 1211C04, 1211C05, 1211C06, 1211C07, 1211C08, 1221C01, 1221C02, 1271C01, 1271C02, 1271C03, 1271C04, 1271C05, 1281C01, 1281C02, 1281C03, 1281C04, 1341C01, 1341C02, 1351C01, 1351C02, 1351C03, 1351C04, 1351C05, 1351C06, 1351C07, 1421C01, 1421C02, 1421C03, 1421C04, 1421C05, 1421C06, 1421C07, 1421C08, 1431C01, 1571C01, 1571C02, 1571C03, 1571C04, 1581C01, 1581C02, 1581C03, 1581C04, 1581C05, 1581C06, 1691C01, 1691C02, 1691C03, 1691C04, 1701C01, 1701C02, 1701C03, 1701C04, 1701C05, 1701C06, 1771C01, 1771C02, 1771C03, 1771C05, 1771C06, 1771C07, 1771C08, 1771C09, 1841C01, 1841C02, 1841C03, 1841C04, 1841C05, 1901C02, 1901C03, 1901C04, 1901C05, 1901C06, 1971C01, 1971C04, 1971C05, 1971C06, 1971C08, 1971C13, 1971C14, 1981C03, 1981C04, 2041C11, 2041C12, 2041C13, 2041C14, 2041C17, 2041C23, 2041C26, 2051C08, 2051C09, 2121C07, 2121C08, 2121C15, 2131C03, 2131C04, 2191C07, 2191C08, 2191C09, 2191C10, 2191C11, 2331C06, 2331C08, 2331C09, 2331C10, 2331C12, 2341C05, 2341C06, 2341C07, 2471C01, 2471C02, 2471C03, 2471C07, 2471C08, 2471C09, 2471C10, 2531C06, 2531C07, 2531C08, 2531C09, 2531C10, 2611C05, 26611C06, 2611C07, 2621C04, 2751C01, 2751C02, 2751C04, 2751C05, 2751C10. 2761C## through 2911C## b) Lower Extremity Drape, Sterile, Cat. No. 89278-10 - Lots 0311C02, 0391C11, 0391C12, 0391C13, 0401C08, 0401C09, 0401C10, 0401C11, 0401C12, 0411C01, 0431C01, 0451C18, 0461C19, 0461C20, 0461C21, 0461C22, 0461C23, 0461C24, 0461C34, 0461C35, 0461C36, 0531C18, 0531C19, 0531C20, 0531C21, 0531C22, 0531C23, 0531C24, 0531C25, 0531C26, 0531C27, 0531C28, 0541C19, 0541C20, 0541C21, 0541C22, 0581C11, 0581C12, 0581C13, 0581C14, 0591C12, 0591C13, 0591C14, 0591C15, 0661C01, 0661C02, 0661C11, 0661C12, 0661C13, 0661C14, 0661C20, 0661C21, 0671C05, 0671C06, 0801C05, 0801C06, 0801C07, 0801C08, 0801C09, 0801C10, 0801C11, 0801C12, 0861C18, 0861C19, 0861C20, 0861C21, 0861C22, 0861C23, 0871C01, 0871C02, 0881C02, 0881C03, 0941C28, 0941C29, 0951C01, 0951C15, 0951C19, 0951C20, 1061C11, 1061C12, 1061C13, 1061C14, 1071C11, 1071C12, 1081C04, 1341C13, 1341C14, 1341C15, 1341C16, 1341C17, 1341C18, 1361C21, 1361C22, 1421C03, 1421C04, 1421C05, 1421C06, 1421C07, 1421C08, 1421C09, 1421C10, 1481C22, 1481C23, 1491C01, 1491C02, 1491C03, 1491C04, 1491C05, 1491C06, 1571C11, 1571C12, 1571C13, 1571C14, 1571C15, 1571C16, 1571C39, 1571C10, 1641C25, 1641C26, 1641C27, 1661C04, 1661C05, 1661C06, 1661C11, 1661C12, 1711C21, 1711C22, 1711C23, 1711C24, 1721C06, 1721C07, 1721C08, 1781C05, 1781C06, 1781C07, 1781C11, 1781C12, 1781C19, 1841C01, 1841C02, 1841C03, 1841C04, 1911C23, 1911C24, 1911C25, 1911C26, 1911C27, 1911C28, 1911C29, 1911C30, 1981C13, 1981C14, 1981C15, 2051C17, 2051C18, 2051C19, 2051C20, 2051C24, 2051C25, 2061C13, 2111C04, 2111C05, 2111C06, 2111C08, 2111C20, 2111C21, 2111C22, 2121C06, 2121C07, 2121C08, 2141C06, 2181C03, 2181C04, 2181C16, 2181C17, 2191C03, 2191C04, 2251C07, 2251C08, 2261C11, 2261C12, 2261C13, 2261C14, 2321C11, 2321C12, 2321C13, 2321C14, 2321C15, 2331C09, 2331C10, 2331C11, 2331C12, 2331C13, 2391C12, 2391C13, 2391C14, 2391C21, 2391C22, 2391C23. 2391C24, 2391C25, 2401C06, 2401C07, 2471C08, 2471C09, 2471C10, 2471C11, 2471C12, 2471C13, 2611C14, 2611C15, 2611C16, 2611C17, 2681C10, 2681C17, 2681C19, 2681C20, 2691C03, 2741C01, 2741C02, 2741C03, 2741C10, 2741C11, 2751C01, 2751C02. 2761## through 2911C## c) Lower Extremity Pack, Sterile - Cat. No. 88471-20 - Lots 0311C01, 0311C02, 0311C03, 0311C04, 0311C05, 0311C06, 0311C07, 0311C08, 0311C09, 0311C10, 0381C01, 0381C02, 0381C03, 0381C04, 0381C05, 0471C01, 0471C02, 0471C03, 0471C04, 0471C05, 0471C06, 0471C07, 0471C08, 0471C09, 0531C01, 0531C02, 0531C03, 0531C04, 0531C05, 0531C06, 0541C01, 0541C02, 0541C03, 0541C04, 0541C05, 0541C06, 0581C01, 0581C02, 0581C03, 0581C04, 0581C05, 0581C06, 0671C01, 0671C02, 0711C01, 0711C02, 0711C03, 0711C04, 0711C05, 0751C01, 0751C02, 0751C03, 0751C04, 0751C05, 0761C01, 0761C02, 0761C03, 0761C04, 0781C01, 0781C02, 0781C03, 0781C04, 0781C05, 0781C06, 0781C07, 0781C08, 0781C09, 0781C10, 0781C11, 0791C01, 0791C02, 0791C03, 0871C01, 0871C02, 0871C03, 0871C04, 0871C05, 0871C06, 0871C07, 0871C08, 0871C09, 0871C10, 0871C11, 0941C01, 0941C02, 0941C03, 0941C04, 0941C05, 0941C06, 1011C01, 1011C02, 1011C03, 1011C04, 1011C05, 1061C01, 1061C02, 1061C03, 1061C04, 1061C05, 1061C06, 1141C01, 1141C02, 1141C03, 1141C04, 1141C05, 1141C06, 1141C07, 1281C01, 1281C02, 1281C03, 1281C04, 1281C05, 1281C06, 1281C07, 1281C08, 1281C09, 1281C10, 1281C11, 1281C12, 1281C13, 1281C14, 1281C15, 1281C16, 1281C17, 1281C18, 1281C19, 1281C20, 1281C21, 1281C22, 1371C01, 1371C02, 1371C03, 1371C04, 1371C05, 1371C06, 1371C07, 1421C01, 1421C02, 1421C03, 1491C01, 1491C02, 1491C03, 1491C04, 1491C05, 1491C06, 1491C07, 1491C08, 1491C09, 1491C10, 1491C11, 1491C12, 1591C01, 1591C02, 1591C03, 1591C04, 1591C05, 1591C06, 1591C07, 1641C01, 1641C02, 1641C03, 1641C04, 1641C05, 1641C06, 1641C07, 1701C01, 1701C02, 1701C03, 1701C04, 1761C01, 1761C02, 1761C03, 1761C04, 1761C05, 1761C06, 1761C07, 1761C08, 1761C09, 1831C01, 1831C02, 1831C03, 1831C04, 1831C05, 1831C06, 1831C07, 1831C08, 1831C09, 1911C06, 1911C07, 1911C08, 1911C09, 1911C10, 1971C01, 1971C02, 1971C03, 1971C04, 1991C01, 1991C02, 2011C05, 2011C06, 2011C07, 2051C06, 2051C07, 2051C08, 2051C09, 2061C09, 2061C10, 2061C11, 2121C08, 2121C09, 2121C10, 2121C10, 2121C11, 2121C12, 2121C13, 2201C01, 2201C02, 2201C03, 2201C04, 2201C05, 2251C05, 2251C06, 2251C07, 2251C08, 2251C09, 2251C10, 2331C13, 2331C14, 2331C15, 2331C16, 2341C01, 2341C02, 2341C03, 2411C14, 2411C15, 2461C01, 2461C02, 2461C03, 2461C04, 2461C05, 2461C06, 2461C07, 2461C08, 2461C09, 2461C10, 2461C11, 2461C12, 2461C13, 2461C14, 2461C15, 2461C16, 2461C17, 2461C18, 2531C09, 2531C10, 2531C11, 2531C12, 2541C01, 2541C02, 2541C03, 2541C04, 2541C05, 2541C06, 2611C06, 2611C07, 2611C08, 2621C02, 2621C03, 2621C04, 2621C05, 2621C06, 2621C07, 2621C08, 2671C07, 2671C08, 2671C09, 2671C10, 2671C11, 2671C12, 2681C02, 2681C03, 2681C04, 2681C07, 2681C08, 2681C09, 2681C10. 2761C## through 2911C## d) Hip Drape, Bulk Pack - Non-sterile, Cat. No. 79346-10 - Lots 0451C01, 0671C01, 0811C01, 0811C02, 1001C01, 1001C02, 1011C01, 1151C01, 1151C02, 1731C01, 1731C02, 1731C03, 1761C01, 1761C02, 1911C08, 1921C09, 1921C10, 2071C08, 2071C10, 2631C05, 2631C06, 2641C11. 2761C## through 2911C## e) Hip Drape, Sterile - Cat. No. 89346-10, Lots 0601C28, 0601C29, 0741C01, 0741C02, 0741C03, 0941C06, 0941C07, 0941C25, 1491C28, 1491C29, 1491C30, 1691C21, 1701C01, 1991C05, 1991C06, 1991C07, 1991C08, 2201C09, 2201C10, 2201C11, 2201C12, 2431C02, 2431C03, 2491C20. 2761C## through 2911C## f) Hip Pack, Sterile - Cat. No. 88453-20 - Lots 0311C01, 0311C02, 0371C01, 0731C01, 1091C01, 1131C01, 2071C12, 2361C01, 2631C08. 2761C## through 2911C## g) ORTHOARTS Knee Arthrscopy Drape, Bulk Non-Sterile - Cat. No. 79267-10, Lots 0311C## through 2911C## h) ORTHOARTS Knee Arthroscopy Drape, Sterile, Cat. No. 89267-10, Lots 0311C## through 2911C## i) ORTHOARTS Knee Arthroscopy Pack, Sterile, Cat. No. 88481-20, Lots 0311C## through 2911C## j) Canton-Potsdam Lower Extremity Pack, Cat. No. 76091-ACM7539, Lots 1291B01, 1571B01, 1921B01, 1981B01, 2071B01, 2211B01, 2411B01 k) Mercer Orthopedic II Pack, Cat. No. 76095-ACM5054, Lots 0321B01, 1171B01, 1231B01, 1481B01, 1571B01, 1721B01, 1911B01, 2121B01, 2321B01, 2641B01 l) 0ORTHOARTS Lower Extremity Pack, Cat. No. 76095-ACM5331, Lots 1011B01, 1231B01, 1441B01, 1801B01, 2211B01, 2401B01, 2551C02 m) Sharon Regional Total Knee Pack, Cat. No. 76097-ACM5463, Lots 1351B01, 1861B01, 2151B01 (Where ## = all sublot numbers) RECALLING FIRM/MANUFACTURER Recalling Firm: Kimberly-Clark Corp., Roswell, GA, by letter on Dec. 17, 2001. Manufacturer: Avent SA de CV Nogales, Sonora, Mexico. Firm initiated recall is ongoing. REASON The fenestrated elastic film can separate from drape causing a break in sterility. VOLUME OF PRODUCT IN COMMERCE 234,166 drapes. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT HA threaded Implant 4.0mm X13.0mm Sterile Endosseous Implants for use in Dental Implant Surgery. Recall # Z-0798-2. CODE Catalog Number HT413, Lot number 150159. RECALLING FIRM/MANUFACTURER Implant Innovations, Inc., Palm Beach Gardens, FL, by telephone on Feb. 21, 2002. Firm initiated recall is complete. REASON Implants may not have the labeled hydroxylapatite coating. VOLUME OF PRODUCT IN COMMERCE 25. DISTRIBUTION CA, NV and MI. _______________________ PRODUCT First Aid Only All Purpose First Aid Kit (Item# FA-143C). Recall # Z-0799-2. CODE Kit Lot #'s: G0060, G0070, G0140, G0210, G0270 H0040, H0110, H0170, H0250 I0010, I0130, I0140, I0180, I0220, I0060 J0180, J0270, K0020 L0190 A0051, A0121 D0061, D0110. RECALLING FIRM/MANUFACTURER First Aid Only, Vancouver, WA, by telephone in Sept. 2001. FDA initiated recall is complete. REASON First aid kits were made using a recalled antiseptic spray that may be subpotent. VOLUME OF PRODUCT IN COMMERCE 89,213 kits containing the antiseptic spray. DISTRIBUTION Nationwide. _______________________ PRODUCT InstaTrak Adult Headset (Part No 1000497). Recall # Z-0800-2; InstaTrak Large Pediatric (Part No 1000948). Recall # Z-0801-2; InstaTrak Small Pediatric (Part No 1000949). Recall # Z-0802-2. The InstaTrak system is intended as an aid to the surgeon for precisely locating anatomical structures anywhere in the human body during either open or percutaneous procedures. CODE InstaTrak Adult Headset (Part No 1000497); InstaTrak Large Pediatric (Part No 1000948); InstaTrak Small Pediatric (Part No 1000949). Lot #’s Product Number Description M004524 1000949 Sm Pediatric Headset M004677 1000497 Adult Headset M004680 1000497 Adult Headset M004681 1000497 Adult Headset M004684 1000497 Adult Headset M004687 1000497 Adult Headset M004387 1000497 Adult Headset M004688 1000497 Adult Headset M004693 1000497 Adult Headset M004694 1000948 Lg Pediatric Headset M005716 1000497 Adult Headset M005717 1000497 Adult Headset M005720 1000497 Adult Headset M005725 1000497 Adult Headset M005728 1000497 Adult Headset M005730 1000497 Adult Headset M005734 1000497 Adult Headset M005735 1000497 Adult Headset M005736 1000948 Lg Pediatric Headset. RECALLING FIRM/MANUFACTURER Visualization Technology, Inc., Lawrence, MA, by letter on Feb. 20, 2002. Firm initiated recall is ongoing. REASON Use of headset in a rotated position may result in undetected system inaccuracy. VOLUME OF PRODUCT IN COMMERCE 2624 Adult; 65 Pediatric. DISTRIBUTION Nationwide. _______________________ PRODUCT Misys Laboratory (formerly FlexiLab) information system. Recall # Z-0803-2. CODE Versions 5.2, 5.23, and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tuscon, AZ, by notice on March 8, 2002. Firm initiated recall is ongoing. REASON Software anomaly may allow patient results to be transposed against another patient header or identification. VOLUME OF PRODUCT IN COMMERCE 765. DISTRIBUTION Nationwide and to United Kingdom, Ireland, Canada, Denmark, Bermuda, Saudi Arabia. _______________________ PRODUCT Kappa 700/600 Dual Chamber (D, DR, and VDD) Implantable Pulse Generator Pacemakers, Models KD700, KD701, KD703, KD706, KDR600, KDR601, KDR603, KDR606, KDR651, KDR653, KDR700, KDR701, KDR703, KDR706, KDR720, KDR721, KDR730, KDR731, KDR733, KVDD700, and KVDD701. Recall # Z-0804- 2/Z-0823-2. CODE Model KD700, serial numbers PHJ600001S - PHJ600953S PHJ200017K - PHJ200142K Model KD701, serial numbers PHK600001S - PHK603292S PHK620001S - PHK625072S PHK100001H - PHK100351H PHK110000H - PHK110072H PHK200001K - PHK200283K PHK600001K - PHK600050K Model KD703, serial numbers PHM600001S - PHM600853S PHM620001S - PHM621580S PHM200001K - PHM200057K PHM600001K - PHM600115K Model KD706, serial numbers PHL600001S - PHL600326S PHL620001S - PHL620311S PHL200001K - PHL200044K PHL600001K - PHL600045K Model KDR600, serial numbers PHE600010S - PHE600474S PHE200021K - PHE200077K Model KDR601, serial numbers PHF600001S - PHF600445S PHF620001S - PHF621222S PHF100001H - PHF132349H PHF200001K - PHF200220K Model KDR603, serial numbers PHH600001S - PHH600101S PHH620001S - PHH620264S PHH100001H - PHH101083H PHH110000H - PHH110161H PHH200025K - PHH200087K PHH600001K - PHH600006K Model KDR606, serial numbers PHG600001S - PHG600046S PHG620001S - PHG620024S PHG100001H - PHG110045H PHG200001K - PHG200037K Model KDR651, serial numbers PLJ100001H - PLJ102138H Model KDR653, serial numbers PLK100001H - PLK100424H Model KDR700, serial numbers PGT600001S - PGT602146S PGT100001H - PGT100359H PGT200005K - PGT200687K PGT240001K - PGT240027K PGT600001K - PGT600066K Model KDR701, serial numbers PGU200001S - PGU200727S PGU600001S - PGU608746S PGU620001S - PGU642826S PGU100001H - PGU157379H PGU174000H - PGU199999H PGU400000H - PGU408983H PGU200001K - PGU200590K PGU600001K - PGU600257K Model KDR703, serial numbers PGY600001S - PGY601668S PGY620001S - PGY623754S PGY100001H - PGY105283H PGY114000H - PGY116188H PGY200014K - PGY200136K PGY600002K - PGY600105K Model KDR706, serial numbers PGW600001S - PGW600825S PGW620001S - PGW621062S PGW100001H - PGW102263H PGW112005H - PGW112647H PGW200001K - PGW200121K PGW600001K - PGW600033K Model KDR720, serial numbers PGP600001S - PGP600156S PGP200001K - PGP200070K PGP600001K - PGP600005K Model KDR721, serial numbers PGR600001S - PGR602899S PGR620001S - PGR628686S PGR100001H - PGR104567H PGR114004H - PGR120551H PGR200001K - PGR200018K Model KDR730, serial numbers PHA600001S - PHA601345S PHA100001H - PHA100104H PHA200001K - PHA200135K PHA600001K - PHA600032K Model KDR731, serial numbers PHB100000S - PHB100011S PHB200001S - PHB200335S PHB600001S - PHB604053S PHB620001S - PHB634479S PHB100001H - PHB100012H PHB200001K - PHB200188K PHB600002K - PHB600054K Model KDR733, serial numbers PHD600001S - PHD602923S PHD620001S - PHD628838S PHD100001H -PHD100054H PHD200001K - PHD200027K PHD600001K - PHD600052K Model KVDD700, serial numbers PHN600001S - PHN600373S PHN000131K PHN600001K - PHN600110K Model KVDD701, serial numbers PHP200001S - PHP200301S PHP600001S - PHP604347S PHP620001S - PHP632878S PHP100001H - PHP101406H PHP111005H - PHP111887H PHP200001K - PHP200470K PHP600002K - PHP600034K. RECALLING FIRM/MANUFACTURER Medtronic, Inc., Minneapolis, MN, by letter dated March 15, 2002. Firm initiated recall is ongoing. REASON Submuscular implant locations (subpectoral, abdominal, etc.) can result in additional stress and repetitive flexing on the implanted pacemaker, causing excessive fatigue and fracture of internal wires supplying power to the pacemaker. VOLUME OF PRODUCT IN COMMERCE 256,759 pacemakers. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Brand Name: IMMULITE 2000 Anti-Thyroglobulin Antibody Common/ Usual Name: IMMULITE 2000 Anti-Thyroglobulin Antibody, Intended for the quantitative measurement of autoantibodies to Thyroglobulin in serum EDTA and heparinized plasma. Recall #Z-0824-2. CODE Model, catalog or code number and manufacturing lot or serial number: 200 test: lot numbers: L2KTG2 202 and L2KTG2 203 600 test: lot numbers: L2KTG6 202 and L2KTG6 203. RECALLING FIRM/MANUFACTURER Recalling Firm: Diagnostic Products Corp., Los Angeles, CA, by bulletin dated Jan. 29, 2002. Manufacturer: EURO/DPC, Ltd. Wales, The United Kingdom. Firm initiated recall is ongoing. REASON Insufficient stability at certain temperatures causes control values to be high. VOLUME OF PRODUCT IN COMMERCE 174. DISTRIBUTION Nationwide and Brazil, Saudi Arabia and People's Republic of China. _______________________ PRODUCT Brand/Common/Usual Name of Device: IMMULITE Anti-TPO This is an in-vitro diagnostic device. It is supplied in 100 and 500 test kits. Model/catalog numbers are: 100 test: LKT01 175 500 test: LKT05 175. Recall # Z-0825-2. CODE Lot numbers include: L2KTG 202, L2KTG 203, L2KTG 204. RECALLING FIRM/MANUFACTURER Diagnostic Products Corp., Los Angeles, CA, by telehone on January 30, 2002. Firm initiated recall is ongoing. REASON Instability caused positively biased control values. VOLUME OF PRODUCT IN COMMERCE 82. DISTRIBUTION Nationwide. _______________________ PRODUCT DeRoyal Vasectomy Tray, a surgical kit, P/N 50-9112. Recall # Z-0826-2. CODE Lot 660242. RECALLING FIRM/MANUFACTURER Recalling Firm: Deroyal Industries, Inc., Powell, TN, by letter dated March 15, 2002. Manufacturer: DeRoyal Surgical, New Tazewell, TN. Firm initiated recall is ongoing. REASON Surgical kits contained recalled Ethicon sutures. VOLUME OF PRODUCT IN COMMERCE 1 case of 20 kits. DISTRIBUTION WI. _______________________ PRODUCT Selector Ultrasonic Surgical Aspirator System; affected part is the Selector Integra Ultrasonic Aspirator Operator's Manual, Part Number: OM 1530000M1; Issue C168-4. Recall # Z-0827-2. CODE Part Number: OM 1530000M1; Issue C168-4. RECALLING FIRM/MANUFACTURER Recalling Firm: Integra Neurocare Llc., San Diego, CA, by letter on March 11, 2002. Manufacturer: Spembly Medical Ltd., England. Firm initiated recall is ongoing. REASON Directions cite Euro approved not US approved sterilization cycle parameters. VOLUME OF PRODUCT IN COMMERCE 88. DISTRIBUTION Nationwide and DC.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________ PRODUCT STA-Deficient VIII Immuno-depleted Plasma for Factor VIII: C Assay by STA Analyzers. Recall # Z-0781-2. CODE Lot #003221, Exp. Date 11/2002 Lot #003431, Exp. Date 12/2002 Lot #011171, Exp. Date 04/2003 Lot #011722, Exp. Date 06/2003. RECALLING FIRM/MANUFACTURER Recalling Firm: Diagnostica Stago, Inc., Parsippany, NJ, by letters on December 15, 2001. Manufacturer: Diagnostic Stago, Taverny, France. Firm initiated recall is ongoing. REASON Gradual decline in stability of the reagent after reconstitution. VOLUME OF PRODUCT IN COMMERCE 1249 boxes x 6 vials. DISTRIBUTION Nationwide and France, Finland, Greece and Germany. _______________________ PRODUCT Immuclone APhL ELISA Kit (IgG and IgM) calibrators. Recall # Z-0783-2. CODE Lot No. 010213. RECALLING FIRM/MANUFACTURER Louisville APL Diagnostics, Inc., Doraville, GA, by telephone on August 16, 2001. Firm initiated recall is complete. REASON IgG and IgM calibrators took too long for color reactions. VOLUME OF PRODUCT IN COMMERCE 50 kits IgG and 50 kits of IgM. DISTRIBUTION CT. _______________________ PRODUCT Unizyme, Recall # Z-0797-2. CODE Lot U0090, exp. 2002/09 Lot U0110, exp. 2002/10. RECALLING FIRM/MANUFACTURER Recalling Firm: Ciba Vision Corp., Duluth, GA, by letter on December 28, 2001. Manufacturer: Cfh Laboratories, L.P., Morris Plains, NJ. Firm initiated recall is ongoing. REASON Contamination with brass particles from the tablet press. VOLUME OF PRODUCT IN COMMERCE 269,807 kits. DISTRIBUTION Nationwide and Internationally.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
_______________________ PRODUCT Safe-Guard (fenbendazole) 20% Natural Protein Deworming Blocks for Beef Cattle 25 lb. The product code is 881205. Recall # V-033-2. CODE Lot numbers: D1218001, D1261001, D1269003, D1313001, D1337001, and D1354002. RECALLING FIRM/MANUFACTURER Recalling Firm: Intervet, Inc., Millsboro, DE, by telephone during the week of Jan. 14, 2002. Manufacturer: Sweetlix LLC, Montgomery, AL. Firm initiated recall is terminated. REASON Mislabeled. VOLUME OF PRODUCT IN COMMERCE 5074 blocks. DISTRIBUTION AR, IN, MT, NE, OK, SD, and TX.END OF ENFORCEMENT REPORT FOR APRIL 17, 2002
####
Office of Public Affairs
Hypertext uploaded by tg 2002-APR-17.