September 26, 2001 01-38
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-557-1, Quesos Zurita, Mexican White Cheese, packed in foil wrapped packages, net wt. 14 oz., Codes: Jan 30 2001 (on side), plant #369630 (on top) REASON: The product was contaminated with Salmonella. MANUFACTURER/RECALLING FIRM: Zurita Cheese Brooklyn, NY RECALLED BY: The firm, by visit on 1/11/01 FIRM INITIATED RECALL: Completed. Recall resulted from inspection and analysis by the New York State Department of Agriculture and Markets. DISTRIBUTION: Brooklyn, NY. QUANTITY: 120 - 130 x 14 oz. packages.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-553-1, Yang Shi Food brand Orange Egg Rolls packed in flexible plastic packages, net wt. 140 grams (5 oz.), 24 - 140 gram pkgs. per case. This is a product of China. The product’s Barcode # is 6 921981 823119. Codes: The product was not coded. The firm recalled all products on the market at the time the recall was initiated. REASON: The product contained the undeclared color additives tartrazine (certifiable as FD&C Yellow #5) & sunset yellow FCF (certifiable as FD&C Yellow #6). The product was also misbranded in that the ingredient statement was not in English. MANUFACTURER: Yik Hoi Trading Company Tsing Yi, Hong Kong, China, RECALLED BY: Strong America Limited Brooklyn, NY, by letter on 10/02/00. FIRM INITIATED RECALL: Completed. Recall resulted from inspection and analysis by the New York State Department of Agriculture and Markets. DISTRIBUTION: NY and MA QUANTITY: 60 Cases (24-140 gram packages per case) _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-554-1, Yang Shi Food brand Chocolate Egg Rolls packed in flexible plastic packages, net wt. 140 grams (5 oz.), 24 - 140 gram pkgs. per case. Product of China. The product’s barcode # is 6 921981 823119. CODE: The product was not coded. The firm recalled all products on the market at the time the recall was initiated. REASON: The product contained undeclared tartrazine (certifiable as FD&C Yellow #5). The product was also misbranded in that the ingredients were not listed in English. MANUFACTURER: Yik Hoi Trading Company Tsing Yi, Hong Kong, China RECALLED BY: Strong America Limited, Brooklyn, NY, by letter dated 10/02/00 FIRM INITIATED RECALL: Completed. Recall resulted from inspection and analysis by the New York State Department of Agriculture and Markets. DISTRIBUTION: NY and CT QUANTITY: 40 cases (24 - 140 gram packages per case) were distributed _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-555-1, Yang Shi Food brand Coconut Egg Rolls packed in flexible plastic packages, net wt. 140 grams (5 oz.), 24 - 140 gram pkgs. per case. Product of China. Barcode # 6 921981 823119. Codes: The product was not coded. The firm recalled all products on the market at the time the recall was initiated. REASON: The product contained undeclared tartrazine (certifiable as FD&C Yellow #5). The product was also misbranded in that the ingredients were not listed in English. MANUFACTURER: Yik Hoi Trading Company Tsing Yi, Hong Kong, China, RECALLED BY: Strong America Limited Brooklyn, NY., by letter on 10/2/00. FIRM INITIATED RECALL: Complete. Recall resulted from inspection and analysis by the New York State Department of Agriculture and Markets. DISTRIBUTION: NY, CT, MA, FL QUANTITY: 50 cases (24 - 140 packages per case) were distributed. _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-556-1, Yang Shi Food brand Strawberry Egg Rolls packed in flexible plastic packages, net wt. 140 grams (5 oz.), 24 - 140 gram pkgs. per case. Product of China. Barcode # is 6 921981 823119. Codes: The product was not coded. The firm recalled all products on the market at the time the recall was initiated. REASON: The product contained undeclared tartrazine (certifiable as FD&C Yellow #5) and the unapproved color additive Ponceau 4R (E124, Acid Red 18). The product was also misbranded in that the ingredients were not listed in English. MANUFACTURER: Yik Hoi Trading Company Tsing Yi, Hong Kong, China RECALLED BY: Strong America Limited Brooklyn, NY, by letter dated 10/02/00. FIRM INITIATED RECALL: Completed. Recall resulted from inspection and analysis by the New York State Department of Agriculture and Markets. DISTRIBUTION: NY, CT and MA QUANTITY: 60 cases (24 - 140 gram pckgs. per case) were distributed. _______________________________ RECALL NUMBER, PRODUCT AND CODE: a) F-559-1 I.M. Good Mountain Mix, packaged in bulk 25 LB cases. b) F-560-1 Hunter Confetti, packaged in 30 LB cases. Codes: The cases are uncoded. REASON: The products contain undeclared FD&C colors: Yellow #5 Lake, Yellow #6, Yellow #6 Lake, Red #40, Red #40 lake, Ble #1, and Blue #1 Lake. MANUFACTURER/RECALLING FIRM: Tropical Nut & Fruit, Inc. Columbus, OH RECALLED BY: Manufacturer, by telephone on 5/22/01 followed by letter on 5/23/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY: a) 500 lbs. b) 1,050 lbs. _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-561-1, Universal Snacks Tender Spice Drops; Packed By Universal Candies, Schiller Park, IL; UPC 51756-50001; Net Wt. 4 oz. plastic bag, 12 bags per case. Codes:No lot number UPC 51756-50001 REASON: The product contained undeclared FD&C Yellow #5 and FD&C Red #40. MANUFACTURER/RECALLING FIRM: Warner Candy Company Schiller Park, IL RECALLED BY: Manufacturer, by telephone on 8/3/01 and letter on 8/17/01. FIRM INITIATED RECALL: Completed. Recall resulted from inspection and analysis by the New York State Department of Agriculture and Markets. DISTRIBUTION: NY and PA QUANTITY: 4,320 packages _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-562-1, Banana Pudding, in 4 oz clear plastic container with clear top. Date code: 8/17/01 REASON: Product contains undeclared Yellow #5 and Yellow #6. MANUFACTURER: S & E Food Midlothian, VA RECALLED BY: Larcon, Inc., d.b.a. S & E Foods Midlothian, VA, by telephone, letter, and visit on 8/14/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: VA and MD QUANTITY: 143 containers _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-563-1, Frozen Orange Muffin Batter, with natural orange flavor, packaged under the Hilltop label (product #319201) and the Foxtail label (product #302201). The products were packed in 16 LB plastic pails, Codes: All codes. REASON: The product contains undeclared FD&C Yellow No. 6. MANUFACTURER/RECALLING FIRM: Foxtail Foods Cincinnati, OH RECALLED BY: The firm, recalled the Foxtail brand product by telephone on 7/24/01 and by e-mail on 7/25/01 and the Hilltop brand by letter on 7/27/01. FIRM INITIATED RECALL: Complete. DISTRIBUTION: IL, PA, TN, SC, MO, NY, GA, and WI. QUANTITY: 113 containers of Foxtail brand and 160 containers of Hilltop brand. _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-564-1, Product is labeled in part: "Sun Chips***MULTIGRAIN SNACKS***ORIGINAL FLAVOR***NET WT. 1 1/2 OZ.***FRITO-LAY, INC. PLANO, TX" and packaged in a flexible foil-type bag. Codes: Two codes are recalled. Code printed in the upper right quadrant of the front of the bag. OCT 02 115220422 and OCT 02 215320522 REASON: The product contains undeclared dairy ingredients due to the presence of Onion Flavor SunChips in Original Flavor packages. MANUFACTURER: Frito-Lay, Inc. Frankfort, IN RECALLED BY: Frito Lay, Inc. Plano, TX, by telephone on 8/21/01 followed by fax letter and notice posted on the Food Allergy and Anaphylaxis Network’s website. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: 9216 packages _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-569-1, "Frito Lay *** Doritos *** Nacho Cheesier! *** Tortilla Chips *** Net Wt. 1 3/4 oz. *** FRITO-LAY, INC. PLANO, TX 75024-4099" Codes: The lot number of the recalled product is located in the lower right quadrant of the front of the bag: June 26 2712 10703 REASON: Undeclared yellow #5, Blue #1 and soy grits due to the presence of Doritos Cooler Ranch Chips being packaged in incorrect packages designed for Doritos Nacho Cheesier chips. MANUFACTURER: Frito-Lay, Inc. Charlotte, NC RECALLED BY: Frito-Lay, Inc Plano, TX, by messages sent on hand-held computers on 5/4/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: NC, SC, VA, TN, WV QUANTITY: 380 cases (18,240: 1 3/4 ounce bags) _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-570-1, Cheddar and Sour Cream flavor Potato Chips labeled in part: "Ruffles***Original** POTATO CHIPS***NET WT. 12 1/4 OZ.***Ingredients: Potatoes, Corn and/or Cottonseed Oil, and Salt***FRITO-LAY, INC. PLANO, TX 75204-4099" and packaged in bags, 9 bags per case. Codes: SEP 25 411220770 Located in the upper right quadrant of the front of the bag. REASON: The product contains undeclared milk ingredients and yellow #6 due to the presence of Cheddar and Sour Cream Potato Chips being packaged in an incorrect package, designed for Ruffles Original Potato Chips. MANUFACTURER: Frito Lay, Inc., Beloit, WI RECALLED BY: Frito Lay, Inc. Dallas, TX, by messages sent via hand-held computers and notice posted on the Food Allergy and Anaphylaxis Network’s website. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL, OH, MN, WI QUANTITY: 290,000 bags (233 cases) RECALLS AND FIELD CORRECTIONS: FOODS – CLASS III _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-568-1, "STONEWALL KITCHEN" Aged Balsamic Vinegar, 500 ml (16.5 oz) glass bottles, Product of Italy, Codes: "STONEWALL KITCHEN" Aged Balsamic Vinegar, 500 ml (16.5 oz) glass Bottle, Imported from Italy REASON: Product contains undeclared sulfites. MANUFACTURER/RECALLING FIRM: Stonewall Kitchen Ltd, York, ME RECALLED BY: Firm, by letter on 5/11/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, and Canada, Bahamas, and Panama QUANTITY: 4531 units
_______________________________ RECALL NUMBER, PRODUCT AND CODE: D-300-1 DIFLUCAN(R)(Fluconazole Tablets), 100 mg., 30 tablet bottle, Rx only Codes: NDC 0049-3420-30 Lot # EXP. DATE 04P015A AUG'02---RECALL 04P016A NOV'02---RECALL 94P029A JAN'02---RECALL REASON: Counterfeit MANUFACTURER/RECALLING FIRM: Unknown. RECALLED BY: Kinray, Inc. Whitestone, NY, by letter on 6/14/01. FIRM INITIATED RECALL: Complete. DISTRIBUTION: NY, NJ, PA, CT, MA, RI. QUANTITY: 174 bottles. _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-301-1/D-303-1 All three products are Breckenridge Pharmaceutical, Inc. brand, Dist. by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL. Manufactured by: ME Pharmaceuticals, Division of VESCO, Inc., Richmond, IN. D-301-1 a) Ferocon Capsules, Hematinic Concentrate with Intrinsic Factor, Rx, 100 unit dose capsules per carton (10 capsule blister card, 10 cards per carton), NDC 51991-635-11. D-302-1 b) Vinatal Forte, Prenatal Vitamin Tablet with Iron, Rx, 90 unit dose tablets (10 tablet blister card, 9 cards per carton), NDC 51991-157-91. D-303-1 c) Vinate Advanced, Prenatal Vitamin and Mineral Supplement, Rx, 90 unit dose tablets (10 tablet blister card, 9 cards per carton), NDC 51991-153- 91. CODES: all lots with expiration date of 1/2003 and prior REASON: Subpotent for Folic Acid. MANUFACTURER/RECALLING FIRM: M.E. Pharmaceuticals, Inc. Economy, IN. RECALLED BY: Manufacturer, via telephone and written notification on 8/30/01 FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: TN QUANTITY: a) 1,324,800 capsules; b) 980,640 tablets; c) 500,000 tablets. _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-304-1 Diphenhist CAPTABS, Antihistamine, (Diphenhydramine HCl) USP, 25 mg, Rugby Brand,100 count bottles. Codes: NDC # 0536-3597-01, Product # 003-5970. Lot # Expiration Date 00C035 03/2002 00J019 09/2002 00K002 10/2002 01A036 01/2003 01C023 03/2003 01E014 05/2003 01F034 06/2003 REASON: Misbranding: Carton labeling incorrectly lists inactive ingredients including but not limited to – color additives. MANUFACTURER/RECALLING FIRM: Advance Pharmaceutical, Inc. Ronkonkoma, NY. RECALLED BY: Manufacturer, by fax and letter on 8/31/01. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: GA. QUANTITY: 22,866 bottles (100s). _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-305-1 Pulmolite, Kit for the preparation of Technetium Tc99m Albumin Aggregated for Injection Sterile and non-pyrogenic Lot 127254; Exp. Date: 01 AUG 02 For Diagnostic Use Rx Only NDA 17-776 Codes: Pulmolite, Lot 127254. Exp. Date: 01 AUG 02 REASON: Lack of assurance of sterility(Crimp seal problems) MANUFACTURER/RECALLING FIRM: Ben Venue Laboratories, Inc. Bedford, OH. RECALLED BY: CIS-US, Inc. Bedford, MA, by letters on 7/27/01. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: Nationwide. QUANTITY: 33,475 vials packaged in 5 vial kits and 30 vial kits.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1613-1, Skin Tissue, ID#990078 REASON: Tissues for transplant, that corresponds to tissue that was implicated in the transmission of E. coli, was distributed MANUFACTURER/RECALLING FIRM: South Texas Blood and Tissue Center, San Antonio, TX RECALLED BY: The recalling firm notified the Texas consignee by facsimile on July 26, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: TX QUANTITY: 1 unitRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1688-1, Recovered Plasma, Unit: 04E19440 REASON: Blood product, collected from a donor who used beef bovine insulin, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross, Dedham, MA RECALLED BY: Questionable Plasma Inquiry was forwarded on December 11, 2000, to the California consignee of the Recovered Plasma. FIRM INITIATED RECALL: Complete DISTRIBUTION: California QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1692-1, Recovered Plasma, unit number 4420897 REASON: Blood product, collected from an unsuitable donor due to a history of medication with bovine insulin, was distributed MANUFACTURER/RECALLING FIRM: LifeSource, Glenview, IL RECALLED BY: The recalling firm notified the consignee, located in Scotland, of the recall by letter on March 26, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Scotland QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1887-1, Red Blood Cells, Units 10622-0732, 10628-2997, 10634-9835 B-1888-1, Cryoprecipitate AHF, Unit 10634-9835 B-1889-1, Fresh Frozen Plasma, Unit 10628-2997 B-1890-1, Platelets, Unit 10628-2997 REASON: Blood products, collected from a donor with a history of having tested positive for Hepatitis C, were distributed. MANUFACTURER/RECALLING FIRM: United Blood Services, Scottsdale, AZ RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, notified consignees located in Arizona by telephone on February 20, 2001 and by letters dated March 2, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: AZ QUANTITY: 6 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1891-1, Red Blood Cells, Unit 0358118 REASON: Blood product, collected from a donor who had not completed the CJD/nvCJD increased risk questions, was distributed. MANUFACTURER/RECALLING FIRM: Community Blood Bank of Erie County, Erie, PA RECALLED BY: The recalling firm notified the consignee located in Pennsylvania by telephone on March 5, 2001 and the unit was returned to the recalling firm and destroyed. FIRM INITIATED RECALL: Complete DISTRIBUTION: PA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1907-1, Red Blood Cells, Unit 5233233 B-1908-1, Cryoprecipitate, Unit 5233233 REASON: Blood products, collected from a donor taking an unknown antibiotic for a yeast infection, were distributed. MANUFACTURER/RECALLING FIRM: Carter Blood Care, Bedford, Texas RECALLED BY: The recalling firm, by letters dated May 10 1999. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: TX QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1909-1, Platelets, Pheresis, Leukoreduced (Split #2), Unit 266166-1372 REASON: Blood product, which had a low platelet count, was distributed. MANUFACTURER/RECALLING FIRM: Blood Systems, Inc., Fort Smith, AR RECALLED BY: The recalling firm notified the consignee located in Texas by letter dated June 1, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 2 units. _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1912-1, Platelets Pheresis, Leukoreduced, Unit 16-356-0488 REASON: Blood product, which was labeled as leukoreduced but had an elevated white blood cell count, was distributed. MANUFACTURER/RECALLING FIRM: United Blood Services, Hattiesburg, MS RECALLED BY: The recalling firm notified the consignee located in Mississippi by telephone on October 23, 2000 and by letter dated November 8, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MS QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1926-1, Cornea, number MSN-2000-0999 REASON: Human tissue for transplantation, collected from a donor in which human immunodeficiency virus (HIV) DNA was detected during testing by polymerase chain reaction (PCR), was distributed. MANUFACTURER/RECALLING FIRM: Lions Eye Bank of Wisconsin, Inc., Madison, WI RECALLED BY: The recalling firm notified the consignee, located in Wisconsin, of the recall by letter on October 5, 2000 FIRM INITIATED RECALL: Complete DISTRIBUTION: WI QUANTITY: 1 unit _____________________________ RECALL NUMBER,PRODUCT AND CODE: B-1942-1/B-1953-1 Products: B-1942-1, Whole Blood (15 units), unit numbers Y 46046, Y 42951, Y 44156, X 39505, Y 72482, Y 29446, Y 31297, X 90706, Y 83913, X 39514, X 39522, Y 72484, Y 29390, Y 36932, and X 39502 B-1943-1, Red Blood Cells (773 units), unit numbers X 68633, X 68606, X 68648, X 68620, X 68947, Y 29494, Y 44513, Y 50113, X 51165, X 68399, Y 44525, X 68401, X 70578, X 71123, X 71162, Y 29462, Y 50111, X 52495, X 66892, Y 42962, Y 44517, Y 44579, Y 44593, Y 50099, Y 50110, Y 50115, Y 50125, Y 50152, X 52425, X 52440, X 52551, X 68396, X 68406, Y 44516, X 52507, X 52560, X 71210, Y 44296, Y 44507, Y 50121, Y 42828, X 68045, X 68717, X 68725, Y 47181, Y 50645, Y 50162, Y 44578, Y 50159, X 51136, X 51600, X 52735, X 52743, X 67157 X 68409, X 68734, X 71159, Y 50106, Y 50959, X 68711, Y 42833, Y 45919, Y 47119, Y 43715, Y 47279, Y 49650, Y 47187, Y 50636, Y 50103, Y 50124, X 71130, Y 47178, Y 50104, X 68040, X 68761, Y 45962, Y 50310, X 66898, X 68699, X 71158, Y 50109, Y 50652, X 68397, Y 50112, Y 50116, Y 50126, X 66899, X 52734, X 52420, X 52558, X 68719, Y 50114, Y 50151, Y 50642, Y 29458, Y 29488, Y 42960, Y 44590, Y 50107, Y 50118, Y 50164, X 52423, X 52432, X 68729, X 70794, X 52433, X 52434, X 52737, X 68404, X 52421, X 71168, Y 50154, X 70835, X 70971, X 70985, Y 42944, X 39951, Y 22918, Y 27981, Y 16788, Y 16791, X 39956, X 39959, Y 72784, Y 28008, Y 28012, Y 09171, Y 22919, Y 04362, X 94774, Y 36936, X 91976, X 93981, Y 26335, Y 72483, Y 72782, X 39512, Y 22900, Y 72786, Y 01495, X 96606, X 97321, Y 29290, Y 31466, Y 37039, Y 39135, Y 39138, Y 39156, Y 41538, Y 44065, Y 44214, Y 47381, Y 72879, Y 74545, Y 24746, Y 26772, Y 27951, Y 39129, Y 39137, Y 39166, Y 41335, Y 41347, Y 41564, Y 41572, Y 43945, Y 44066, Y 44084, Y 47654, Y 74607, Y 87232, Y 87368, X 91877, X 96421, Y 27016, Y 28083, Y 28116, Y 34239, Y 34776, Y 36991, Y 37046, Y 37057, Y 39154, Y 39311, Y 41156, Y 41162, Y 41338, Y 41520, Y 41583, Y 43130, Y 72603, Y 74566, Y 74686, Y 74804, Y 74815, Y 86479, Y 86488, Y 86572, Y 87227, Y 87229, Y 87242, Y 87359, Y 87372, Y 87387, Y 87388, Y 87397, Y 87431, Y 87435, X 97309, X 97422, X 97516, Y 24738, Y 24744, Y 26820, Y 26822, Y 26962, Y 26964, Y 26993, Y 26994, Y 27959, Y 28026, Y 39299, Y 39617, Y 41171, Y 41325, Y 41333, Y 41528, Y 41530, Y 41581, Y 44051, Y 44067, Y 72617, Y 72880, Y 72889, Y 74456, Y 74524, Y 74534, Y 74623, Y 74662, Y 74847, Y 83691, Y 83708, Y 86333, Y 86497, Y 87269, Y 87367, Y 87400, Y 24736, Y 24977, Y 27003, Y 27955, Y 28030, Y 28031, Y 28071, Y 31476, Y 31487, Y 36018, Y 36399, Y 37040, Y 37048, Y 37051, Y 37059, Y 39150, Y 39295, Y 39369, Y 39372, Y 39440, Y 39479, Y 39623, Y 41370, Y 41558, Y 41560, Y 41562, Y 41565, Y 41568, Y 41571, Y 44069, Y 44212, Y 44249, Y 72200, Y 72616, Y 74477, Y 74537, Y 74551, Y 74602, Y 83710, X 97318, X 97567, Y 26985, Y 26988, Y 27002, Y 28085, Y 28137, Y 31494, Y 39124, Y 39620, Y 41160, Y 41334, Y 41369, Y 41371, Y 41513, Y 41516, Y 41523, Y 44748, Y 47374, Y 72184, Y 72185, Y 72187, Y 72842, Y 72884, Y 74543, Y 74546, Y 74550, Y 74651, Y 83716, Y 87198, Y 87258, Y 87289, Y 87377, Y 87382, Y 87432, Y 87433, X 91771, Y 00424, Y 17348, Y 26976, Y 27008, Y 27890, Y 37584, Y 37879, Y 38306, Y 38571, Y 74483, Y 17341, Y 18401, Y 25363, Y 26058, Y 26300, Y 26766, Y 26778, Y 26961, Y 27019, Y 27025, Y 27870, Y 27880, Y 27892, Y 29288, Y 34807, Y 37167, Y 37594, Y 37596, Y 37885, Y 37925, Y 37933, Y 38282, Y 38286, Y 38290, Y 38516, Y 48363, Y 74469, Y 74500, X 91125, X 97572, Y 28135, Y 47450, Y 47456, Y 72180, Y 74512, Y 87358, Y 87360, Y 83715, Y 86480, Y 87276, Y 87380, X 91132, X 91135, Y 24760, Y 25374, Y 28075, Y 28131, Y 36994, Y 41552, Y 41554, Y 44183, X 91876, X 97306, X 97310, X 97425, X 97568, Y 29314, Y 35858, Y 37053, Y 37060, Y 39140, Y 39273, Y 41164, Y 41166, Y 41327, Y 41342, Y 41343, Y 41345, Y 41532, Y 41553, Y 41559, Y 41561, Y 41563, Y 41569, Y 41573, Y 43157, Y 44041, Y 44625, Y 47444, Y 47445, Y 74458, Y 74533, Y 74571, Y 83697, Y 86337, Y 86352, Y 86490, Y 87231, Y 87234, Y 87236, Y 87244, Y 87246, Y 87247, Y 87275, Y 87278, Y 87281, Y 87384, Y 87404, Y 87436, Y 28025, Y 39297, Y 39371, Y 39443, Y 41328, Y 41329, Y 44071, Y 72599, Y 87403, Y 87405, Y 26299, Y 26969, Y 27017, Y 27875, Y 37283, Y 37422, Y 37423, Y 37881, Y 37902, Y 38281, Y 38307, Y 46875, Y 47683, Y 17534, Y 18386, Y 18467, Y 25375, Y 26298, Y 26992, Y 31479, Y 35312, Y 37161, Y 37169, Y 37890, Y 37913, Y 37930, Y 37943, Y 44040, Y 48349, Y 48358, Y 74474, Y 01959, Y 01964, Y 01966, Y 25372, Y 26076, Y 27001, Y 37278, Y 37420, Y 37905, Y 37937, Y 37939, Y 38220, Y 38269, Y 38295, Y 38305, Y 38481, Y 38572, Y 46789, Y 47687, Y 44631, X 91792, X 91794, X 91903, X 97492, Y 26989, Y 27884, Y 27887, Y 34798, Y 37874, Y 37878, Y 37904, Y 37935, Y 38270, Y 38275, Y 38288, Y 38292, Y 38317, Y 46783, Y 47692, Y 47697, Y 74499, Y 74502, X 91121, X 91166, X 97587, Y 26995, Y 27014, Y 27031, Y 27876, Y 27893, Y 37041, Y 37591, Y 37892, Y 37894, Y 37929, Y 46878, Y 48352, Y 74482, X 91793, Y 37877, Y 49971, X 97440, Y 28077, Y 39169, Y 43131, Y 44062, Y 86223, Y 17342, Y 26978, Y 26987, Y 27013, Y 27881, Y 27885, Y 27896, Y 37303, Y 37883, Y 38284, Y 38291, Y 46368, Y 47681, Y 73211, Y 73251, Y 74497, X 91144, Y 01869, Y 18461, Y 18469, Y 27010, Y 37910, Y 37927, Y 38224, Y 38227, Y 38261, Y 38300, X 97455, Y 24724, Y 28121, Y 35314, Y 39172, Y 39177, Y 39316, Y 41324, Y 41586, Y 44617, Y 44658, Y 44777, Y 83699, Y 83700, Y 83703, Y 83719, Y 86545, Y 86602, Y 87233, Y 87277, Y 87295, Y 87375, Y 87415, Y 87429, X 91774, X 91780, Y 01870, Y 01961, Y 17343, Y 17522, Y 17558, Y 17569, Y 18455, Y 18457, Y 18475, Y 25362, Y 26965, Y 27004, Y 37891, Y 37909, Y 37920, Y 38264, Y 38319, Y 38320, Y 47698, Y 44669, Y 74668, X 91161, X 91167, X 91772, X 91777, Y 01976, Y 01979, Y 18391, Y 18465, Y 26302, Y 26966, Y 26972, Y 27030, Y 34777, Y 34808, Y 36992, Y 37062, Y 37277, Y 37284, Y 37898, Y 37907, Y 37914, Y 37932, Y 37942, Y 38277, Y 38293, Y 38298, Y 38303, Y 38325, Y 38521, Y 38522, Y 41344, Y 41570, Y 46358, Y 47680, Y 47686, Y 47702, Y 47703, Y 74461, Y 36401, Y 39122, Y 39149, Y 41346, Y 72855, Y 86543, Y 86573, Y 87228, Y 87230, Y 87240, Y 87252, Y 87257, Y 87283, Y 87376, Y 87383, Y 87428, X 96608, X 97510, X 97573, Y 24694, Y 24742, Y 31484, Y 35301, Y 39280, Y 39482, Y 41519, Y 44134, Y 74535, Y 74549, Y 83698, Y 87239, X 97303, Y 24983, Y 25366, Y 26304, Y 26305, Y 26970, Y 26971, Y 26980, Y 26999, Y 29630, Y 39141, Y 41326, Y 44253, Y 45362, Y 72179, Y 72619, Y 74464, Y 74536, Y 18387, Y 37888, Y 37901, Y 37941, Y 74491, Y 72188, X 91137, X 97311, Y 24737, Y 26061, Y 28038, Y 33797, Y 44046, Y 44073, Y 24692, Y 24747, Y 28035, Y 28063, Y 28072, X 97435, X 97336, Y 29269, Y 34778, Y 37058, Y 39136, Y 39142, Y 39159, Y 39394, Y 41341, Y 44047, Y 44137, Y 44653, Y 44773, Y 74459, Y 74519, Y 74538, Y 76248, Y 86492, Y 86502, Y 86537, Y 87241, Y 87279, Y 87282, Y 87294, Y 87378, Y 87385, Y 17523, Y 83705, Y 87274, Y 87361, Y 87369, Y 87379, Y 87394, Y 87396, X 96601, X 97524, X 97580, X 97581, X 97585, Y 84204, X 97294, X 77927, X 95282, Y 26053, Y 26067, Y 37704, X 87338, Y 31579, Y 31580, X 91833, Y 24755, Y 37473, Y 37476, Y 43210, Y 23243, Y 34825, Y 34826, Y 31578, X 93879, Y 86598, and Y 46354 B-1944-1, Red Blood Cells, Irradiated (8 units), unit numbers X 52443, Y 50100, Y 41575, Y 31497, Y 87297, Y 72181, Y 41336, and Y 73215 B-1945-1, Red Blood Cells, Leukocytes Reduced (3 units), unit numbers Y 74813, Y 87284, and Y 87238 B-1946-1, Red Blood Cells, Leukocytes Reduced Irradiated (1 unit), unit number Y 72785 B-1947-1, Platelets (321 units), unit numbers X 51136, X 52434, X 52737, X 70794, Y 42962, Y 44517, Y 44579, X 51600, X 71123, X 71159, X 71168, Y 50642, X 52420, X 52423, X 52425, X 52432, X 52440, X 52507, X 52551, X 52558, X 52560, X 52734, X 52735, X 52743, X 71162, Y 42960, Y 44296, X 68729, Y 42828, Y 42833, Y 45962, X 67157, X 68399, X 68409, X 70578, Y 47181, Y 47279, X 68404, Y 44525, X 96601, X 97585, Y 39440, Y 39623, Y 41342, Y 41528, Y 41532, Y 72200, Y 74813, Y 86545, Y 87258, Y 87289, Y 87294, Y 87358, Y 87368, Y 87376, Y 87383, Y 87385, X 97510, X 97524, Y 28031, Y 28085, Y 37040, Y 39124, Y 47654, Y 87236, Y 87238, Y 87278, Y 87279, Y 87282, Y 87377, Y 87432, X 91135, X 91876, X 96606, X 97492, X 97572, X 97573, Y 24694, Y 24983, Y 26058, Y 28135, Y 34239, Y 34778, Y 36991, Y 37046, Y 37062, Y 39141, Y 39169, Y 39369, Y 39479, Y 41324, Y 41326, Y 41329, Y 41338, Y 41345, Y 41530, Y 41536, Y 41538, Y 41559, Y 41580, Y 41586, Y 47445, Y 72603, Y 86573, Y 87240, Y 87361, Y 87367, Y 87375, Y 87379, Y 87387, Y 87394, Y 87396, Y 87397, Y 87429, Y 87433, Y 87435, X 91137, X 97303, X 97317, Y 72855, Y 72889, Y 74535, Y 74549, Y 74607, Y 87230, Y 87252, Y 87405, Y 87428, Y 24692, Y 24724, Y 24736, Y 24737, Y 24738, Y 24744, Y 28030, Y 28035, Y 28071, Y 28075, Y 39297, Y 39316, Y 39482, Y 41347, Y 41572, Y 72180, Y 72185, Y 74512, Y 74602, Y 74651, Y 74662, Y 74668, Y 26076, Y 35301, Y 36018, Y 37057, Y 41553, Y 41571, Y 41573, Y 41583, Y 72880, Y 74533, Y 74543, Y 74550, Y 87231, Y 87234, Y 87246, Y 87269, Y 87275, Y 87382, Y 87388, Y 87436, X 91132, X 97310, Y 17569, Y 18391, Y 18465, Y 26304, Y 26971, Y 27013, Y 27014, Y 27876, Y 27890, Y 34807, Y 37877, Y 37883, Y 37891, Y 37902, Y 38522, X 91877, X 97580, Y 34776, Y 36399, Y 37051, Y 39135, Y 39156, X 97311, X 97318, X 97321, X 97568, Y 24977, Y 31484, Y 35312, Y 35858, Y 39273, Y 39280, Y 39295, Y 39371, Y 39443, Y 39620, Y 41516, Y 41558, Y 41560, Y 41562, Y 41565, Y 41568, Y 44067, Y 44069, Y 44183, Y 44212, Y 44249, Y 44658, Y 44669, Y 47374, Y 47456, Y 74456, Y 74477, Y 87227, Y 87247, Y 87281, Y 87284, Y 87359, X 97336, X 97440, Y 72617, Y 74519, Y 74538, X 91771, X 91777, X 91780, X 91793, X 91903, Y 17558, Y 18386, Y 34808, Y 38264, Y 74499, Y 74502, Y 27008, Y 27019, Y 27885, Y 74483, Y 18387, Y 37169, Y 37878, Y 37929, Y 37935, Y 37939, Y 38282, Y 38300, Y 27010, Y 25363, Y 25375, Y 26300, Y 26969, Y 26999, Y 27893, Y 74461, Y 74469, Y 74497, Y 26989, Y 37890, Y 37914, Y 37937, Y 38572, X 97516, Y 39150, Y 39154, Y 01967, Y 26985, Y 27031, X 97567, Y 41344, Y 41552, Y 41554, Y 41569, Y 41570, Y 44214, Y 44253, Y 44631, Y 44748, Y 44777, Y 45362, X 91161, X 91167, Y 17522, Y 18461, Y 18469, Y 25362, Y 27030, Y 27870, Y 27884, Y 37584, Y 37874, Y 37888, Y 37898, Y 37925, Y 37933, Y 38275, Y 38284, Y 38305, Y 38317, Y 41328, Y 41343, Y 44071, Y 47450, Y 74524, Y 74546, Y 39140, Y 43130, Y 43131, Y 44617, and Y 47444 B-1948-1, Platelets, Irradiated (13 units), unit numbers X 51165, Y 44625, Y 86543, Y 87228, Y 87378, Y 87380, Y 31497, Y 33797, Y 39172, Y 41563, Y 41564, Y 41575, and Y 72179 B-1949-1, Platelets Pheresis, Leukocytes Reduced (4 units), unit numbers Y 23980, Y 66077, Y 20820, and Y 20820 B-1950-1, Cryoprecipitated AHF (9 units), unit numbers Y 86223, Y 41341, Y 41325, Y 41333, Y 41335, Y 41369, Y 41370, Y 41371, and Y 44066 B-1951-1, Fresh Frozen Plasma (164 units), unit numbers X 68406, X 70985, Y 47178, Y 50652, X 52425, X 52558, X 52560, X 52735, X 68396, Y 42962, Y 44525, Y 50645, X 68404, X 71162, Y 44578, Y 44590, X 51600, X 52423, X 52507, X 71168, Y 44296, X 71123, X 68040, X 68729, X 66898, X 70579, X 71158, Y 47119, X 70835, X 68699, Y 45919, X 68734, Y 50642, X 52421, X 68409, X 71210, X 71159, X 52434, Y 41336, Y 44041, X 91877, X 97303, X 97310, X 97321, X 97425, Y 24694, Y 24737, Y 24747, Y 28135, Y 28137, Y 44748, Y 72855, Y 35301, Y 38300, Y 38317, Y 38516, Y 44065, Y 87280, Y 87386, X 96601, X 97524, X 97567, Y 28116, Y 37596, Y 72879, Y 24738, Y 26076, Y 28031, Y 28038, Y 28085, Y 37046, Y 37169, Y 39617, Y 41345, Y 44047, Y 44084, Y 44134, Y 44137, Y 44214, Y 47654, Y 74500, Y 28083, Y 44046, Y 28008, Y 38521, X 91167, Y 17569, Y 24736, Y 74461, X 97581, X 91876, X 97309, Y 31466, Y 38305, Y 39177, X 96608, X 91793, Y 24977, Y 28030, Y 37913, Y 38275, Y 74469, X 96606, X 97568, X 97580, Y 17522, Y 18387, Y 18391, Y 18467, Y 18469, Y 37878, Y 38319, Y 41580, Y 37278, Y 38303, X 91771, X 91780, Y 37167, X 97422, Y 38269, Y 38282, Y 38277, Y 18455, Y 18461, Y 27880, Y 37885, Y 18465, Y 28075, Y 41346, Y 44040, X 97585, Y 38320, Y 17348, Y 37161, Y 38220, Y 38224, Y 38270, X 97516, X 97587, Y 24692, Y 28063, Y 28071, Y 28131, Y 37060, Y 73251, Y 28012, Y 28035, Y 37888, Y 43945, X 97572, X 97573, Y 17534, Y 27881, Y 28025, Y 28077, Y 18457, Y 38227, Y 38293, X 91125, Y 39394, Y 41334, Y 01869, Y 01967, Y 38306 B-1952-1, Plasma, Cryoprecipitate Reduced (2 units), unit numbers Y 41325 and Y 41370 B-1953-1, Recovered Plasma (613 units), unit numbers X 68606, X 68620, X 68621, X 68633, X 68648, X 68947, X 51165, X 52420, X 52432, X 52495, X 52734, X 52737, X 52743, X 66892, X 66897, X 66899, X 68045, X 68399, X 68711, X 68717, X 68719, X 68725, X 68761, X 70578, X 70794, X 70971, X 71493, Y 29451, Y 29458, Y 29462, Y 29488, Y 29494, Y 42828, Y 42944, Y 42960, Y 43715, Y 44507, Y 44513, Y 44516, Y 44579, Y 44593, Y 45962, Y 47187, Y 49650, Y 50099, Y 50100, Y 50103, Y 50104, Y 50106, Y 50107, Y 50109, Y 50110, Y 50111, Y 50112, Y 50113, Y 50114, Y 50115, Y 50116, Y 50118, Y 50121, Y 50124, Y 50125, Y 50126, Y 50151, Y 50152, Y 50154, Y 50159, Y 50162, Y 50164, Y 50310, Y 50636, Y 50959, X 51136, X 52433, X 52440, X 52443, X 52551, X 67157, X 68397, Y 42833, Y 44517, Y 47181, Y 47279, X 39512, X 39951, X 39956, X 39959, X 87347, X 91121, X 91144, X 91148, X 91166, X 91772, X 91790, X 91792, X 91903, X 91976, X 93981, X 94774, X 96421, X 97332, X 97336, X 97435, X 97440, Y 00424, Y 01495, Y 01959, Y 01961, Y 01964, Y 01966, Y 01976, Y 01979, Y 04362, Y 04451, Y 04452, Y 09171, Y 14032, Y 16788, Y 16791, Y 17341, Y 17343, Y 17523, Y 17558, Y 18386, Y 18401, Y 18475, Y 22900, Y 22918, Y 22919, Y 24724, Y 24742, Y 24744, Y 24746, Y 24760, Y 24983, Y 25362, Y 25363, Y 25366, Y 25372, Y 25374, Y 25375, Y 26061, Y 26298, Y 26299, Y 26300, Y 26302, Y 26304, Y 26305, Y 26335, Y 26766, Y 26772, Y 26778, Y 26820, Y 26822, Y 26961, Y 26962, Y 26964, Y 26965, Y 26966, Y 26969, Y 26970, Y 26971, Y 26972, Y 26976, Y 26978, Y 26980, Y 26985, Y 26987, Y 26988, Y 26989, Y 26990, Y 26992, Y 26993, Y 26994, Y 26995, Y 26999, Y 27001, Y 27002, Y 27003, Y 27004, Y 27008, Y 27010, Y 27014, Y 27016, Y 27017, Y 27025, Y 27030, Y 27031, Y 27870, Y 27875, Y 27876, Y 27884, Y 27885, Y 27887, Y 27890, Y 27892, Y 27893, Y 27896, Y 27955, Y 27981, Y 28072, Y 28121, Y 29269, Y 29288, Y 29290, Y 29314, Y 29630, Y 31476, Y 31479, Y 31484, Y 31487, Y 31494, Y 31497, Y 33797, Y 34239, Y 34776, Y 34777, Y 34778, Y 34798, Y 34807, Y 35312, Y 35314, Y 35858, Y 36018, Y 36399, Y 36401, Y 36936, Y 36991, Y 36992, Y 36994, Y 37039, Y 37040, Y 37041, Y 37048, Y 37051, Y 37053, Y 37057, Y 37058, Y 37059, Y 37062, Y 37277, Y 37283, Y 37284, Y 37303, Y 37422, Y 37423, Y 37591, Y 37594, Y 37877, Y 37879, Y 37881, Y 37890, Y 37891, Y 37898, Y 37901, Y 37904, Y 37907, Y 37909, Y 37910, Y 37914, Y 37920, Y 37925, Y 37927, Y 37929, Y 37932, Y 37933, Y 37935, Y 37937, Y 37939, Y 37942, Y 37943, Y 38261, Y 38264, Y 38281, Y 38286, Y 38288, Y 38290, Y 38291, Y 38292, Y 38298, Y 38307, Y 38481, Y 38522, Y 38571, Y 39124, Y 39129, Y 39135, Y 39136, Y 39137, Y 39138, Y 39140, Y 39141, Y 39142, Y 39149, Y 39150, Y 39154, Y 39156, Y 39159, Y 39166, Y 39172, Y 39273, Y 39280, Y 39295, Y 39297, Y 39311, Y 39316, Y 39369, Y 39371, Y 39372, Y 39440, Y 39443, Y 39479, Y 39482, Y 39620, Y 39623, Y 41156, Y 41160, Y 41162, Y 41164, Y 41166, Y 41168, Y 41171, Y 41324, Y 41326, Y 41327, Y 41328, Y 41329, Y 41333, Y 41335, Y 41338, Y 41341, Y 41342, Y 41343, Y 41344, Y 41347, Y 41369, Y 41371, Y 41513, Y 41516, Y 41519, Y 41520, Y 41523, Y 41528, Y 41530, Y 41532, Y 41538, Y 41552, Y 41553, Y 41554, Y 41555, Y 41558, Y 41560, Y 41562, Y 41563, Y 41564, Y 41565, Y 41568, Y 41569, Y 41570, Y 41571, Y 41572, Y 41573, Y 41575, Y 41581, Y 41583, Y 41586, Y 43130, Y 43131, Y 43157, Y 44062, Y 44066, Y 44067, Y 44069, Y 44183, Y 44212, Y 44249, Y 44253, Y 44617, Y 44625, Y 44631, Y 44653, Y 44658, Y 44773, Y 44777, Y 45362, Y 46354, Y 46358, Y 46368, Y 46783, Y 46789, Y 46875, Y 46878, Y 47374, Y 47381, Y 47444, Y 47445, Y 47450, Y 47456, Y 47680, Y 47681, Y 47683, Y 47686, Y 47687, Y 47692, Y 47695, Y 47698, Y 47702, Y 47703, Y 48349, Y 48352, Y 48358, Y 48363, Y 49290, Y 49971, Y 72619, Y 72782, Y 74459, Y 74537, Y 74623, Y 74686, Y 76248, Y 87232, Y 87400, X 91132, X 91135, X 91137, X 91161, X 91777, X 97311, X 97317, X 97318, X 97455, X 97492, X 97510, Y 01870, Y 26058, Y 27013, Y 27019, Y 27951, Y 34808, Y 37584, Y 37874, Y 37883, Y 37892, Y 37894, Y 37902, Y 37905, Y 38284, Y 38295, Y 38325, Y 38572, Y 39121, Y 39122, Y 39169, Y 41559, Y 41561, Y 44071, Y 44669, Y 72180, Y 72188, Y 74456, Y 74482, Y 74488, Y 74499, Y 74502, Y 74550, Y 87247, Y 87274, Y 87275, Y 87281, Y 87358, Y 87404, Y 87405, Y 87415, Y 87433, Y 72179, Y 72181, Y 72184, Y 72185, Y 72187, Y 72200, Y 72483, Y 72599, Y 72603, Y 72616, Y 72617, Y 72784, Y 72785, Y 72786, Y 72842, Y 72880, Y 72884, Y 72889, Y 73211, Y 73215, Y 74458, Y 74464, Y 74474, Y 74477, Y 74483, Y 74491, Y 74497, Y 74512, Y 74519, Y 74524, Y 74533, Y 74534, Y 74535, Y 74536, Y 74538, Y 74543, Y 74545, Y 74546, Y 74549, Y 74551, Y 74566, Y 74571, Y 74602, Y 74607, Y 74651, Y 74662, Y 74668, Y 74804, Y 74813, Y 74815, Y 74847, Y 83691, Y 83697, Y 83698, Y 83699, Y 83700, Y 83703, Y 83705, Y 83708, Y 83710, Y 83715, Y 83716, Y 83719, Y 86333, Y 86337, Y 86352, Y 86479, Y 86488, Y 86490, Y 86492, Y 86502, Y 86537, Y 86543, Y 86545, Y 86572, Y 86573, Y 86602, Y 87198, Y 87227, Y 87228, Y 87229, Y 87230, Y 87231, Y 87233, Y 87234, Y 87236, Y 87238, Y 87239, Y 87240, Y 87241, Y 87242, Y 87244, Y 87246, Y 87252, Y 87257, Y 87258, Y 87269, Y 87276, Y 87277, Y 87278, Y 87279, Y 87282, Y 87283, Y 87284, Y 87289, Y 87294, Y 87295, Y 87297, Y 87359, Y 87360, Y 87361, Y 87367, Y 87368, Y 87369, Y 87372, Y 87375, Y 87376, Y 87377, Y 87378, Y 87379, Y 87380, Y 87382, Y 87383, Y 87384, Y 87385, Y 87387, Y 87388, Y 87394, Y 87396, Y 87397, Y 87403, Y 87428, Y 87429, Y 87430, Y 87431, Y 87432, Y 87435, and Y 87436 REASON: Blood products, incorrectly tested for antibodies to human immunodeficiency virus types 1 and 2 (anti-HIV-1/2), hepatitis B surface antigen (HBsAg), or antibodies to human T lymphotropic virus types I and II (anti-HTLV-I/II), were distributed. MANUFACTURER/RECALLING FIRM: Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL RECALLED BY: The recalling firm notified the consignees of the recall by letters dated July 19, 2001, that were delivered by hand and certified mail. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: IL, IN, FL, NJ, MO, CA, MA, TX, PA, TN, IA and Switzerland QUANTITY: 1,396 unitsRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1653-1, Source Plasma, Unit G-316340-020 REASON: Blood product, which was collected from a donor with an elevated body temperature, was distributed. MANUFACTURER/RECALLING FIRM: Alpha Therapeutic Corporation - SNA, McAllen, Texas RECALLED BY: The recalling firm notified the California consignee by fax on January 16, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1884-1, Red Blood Cells, Leukoreduced, Unit 4000806 B-1885-1, Recovered Plasma, Unit 4000806 REASON: Blood products, which were collected form a donor with an elevated body temperature, were distributed. MANUFACTURER/RECALLING FIRM: Community Blood Bank of Erie County, Erie, PA RECALLED BY: The recalling firm notified the Pennsylvania consignee of the Red Blood Cells by telephone on June 7, 2001 and by letter dated June 15, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: PA QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1886, Red Blood Cells, Leukoreduced, Irradiated Units 07FF93472, 07FF93483, 07FF93462, 07FF93430, 07GG03084, 07GG03081, 07FF93215, 07FG92338, 07FG92342, 07FF93022, 07FF93408, 07FF93410, 07GG03469, 07FH02854, 07FK56178, 07GH00150, 07FG91309, 07FF92513, 07FF93473, 07GK03042, 07GG03059, 07FF93463, 07FF93464 REASON: Blood products, stored in an unmonitored refrigerator, were distributed. MANUFACTURER/RECALLING FIRM: American National Red Cross, Arizona Region, Tucson, AZ RECALLED BY: The recalling firm notified consignees located in Arizona by letters dated March 12, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: Arizona QUANTITY: 23 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1892, Red Blood Cells, Washed, unit 07FN18713 REASON: Blood product, which failed the parameters for red blood cell recovery, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Tucson, AZ. RECALLED BY: The recalling firm notified the consignee located in Arizona by letter dated April 25, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1910-1, Red Blood Cells, Leukoreduced, Units 16354-0868, 16354-0869 REASON: Blood products, which were labeled as leukoreduced but failed quality control testing due to an elevated white blood cell count, were distributed. MANUFACTURER/RECALLING FIRM: United Blood Services, Blood Systems, Inc., Meridian, MS RECALLED BY: The recalling firm notified the consignees located in Mississippi by telephone on June 16, 2000 and by letter dated July 12, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MS QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1911-1, Red Blood Cells, Leukoreduced, Units 16-354-5697 REASON: Blood product, which was labeled as leukoreduced but failed quality control testing due to an elevated white blood cell count, was distributed. MANUFACTURER/RECALLING FIRM: United Blood Services, Blood Systems, Inc., Hattiesburg, MS RECALLED BY: The recalling firm notified the consignee located in Mississippi by telephone on July 10, 2000 and by letter dated August 4, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MS QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1954-1 Recovered Plasma, unit numbers X 39512, X 39951, X 39956, X 39959, X 87347, X 91121, X 91144, X 91148, X 91166, X 91772, X 91790, X 91792, X 91903, X 91976, X 93981, X 94774, X 96421, X 97332, X 97336, X 97435, X 97440, Y 00424, Y 01495, Y 01959, Y 01961, Y 01964, Y 01966, Y 01976, Y 01979, Y 04362, Y 04451, Y 04452, Y 09171, Y 14032, Y 16788, Y 16791, Y 17341, Y 17343, Y 17523, Y 17558, Y 18386, Y 18401, Y 18475, Y 22900, Y 22918, Y 22919, Y 24724, Y 24742, Y 24744, Y 24746, Y 24760, Y 24983, Y 25362, Y 25363, Y 25366, Y 25372, Y 25374, Y 25375, Y 26061, Y 26298, Y 26299, Y 26300, Y 26302, Y 26304, Y 26305, Y 26335, Y 26766, Y 26772, Y 26778, Y 26820, Y 26822, Y 26961, Y 26962, Y 26964, Y 26965, Y 26966, Y 26969, Y 26970, Y 26971, Y 26972, Y 26976, Y 26978, Y 26980, Y 26985, Y 26987, Y 26988, Y 26989, Y 26990, Y 26992, Y 26993, Y 26994, Y 26995, Y 26999, Y 27001, Y 27002, Y 27003, Y 27004, Y 27008, Y 27010, Y 27014, Y 27016, Y 27017, Y 27025, Y 27030, Y 27031, Y 27870, Y 27875, Y 27876, Y 27884, Y 27885, Y 27887, Y 27890, Y 27892, Y 27893, Y 27896, Y 27955, Y 27981, Y 28072, Y 28121, Y 29269, Y 29288, Y 29290, Y 29314, Y 29630, Y 31476, Y 31479, Y 31484, Y 31487, Y 31494, Y 31497, Y 33797, Y 34239, Y 34776, Y 34777, Y 34778, Y 34798, Y 34807, Y 35312, Y 35314, Y 35858, Y 36018, Y 36399, Y 36401, Y 36936, Y 36991, Y 36992, Y 36994, Y 37039, Y 37040, Y 37041, Y 37048, Y 37051, Y 37053, Y 37057, Y 37058, Y 37059, Y 37062, Y 37277, Y 37283, Y 37284, Y 37303, Y 37422, Y 37423, Y 37591, Y 37594, Y 37877, Y 37879, Y 37881, Y 37890, Y 37891, Y 37898, Y 37901, Y 37904, Y 37907, Y 37909, Y 37910, Y 37914, Y 37920, Y 37925, Y 37927, Y 37929, Y 37932, Y 37933, Y 37935, Y 37937, Y 37939, Y 37942, Y 37943, Y 38261, Y 38264, Y 38281, Y 38286, Y 38288, Y 38290, Y 38291, Y 38292, Y 38298, Y 38307, Y 38481, Y 38522, Y 38571, Y 39124, Y 39129, Y 39135, Y 39136, Y 39137, Y 39138, Y 39140, Y 39141, Y 39142, Y 39149, Y 39150, Y 39154, Y 39156, Y 39159, Y 39166, Y 39172, Y 39273, Y 39280, Y 39295, Y 39297, Y 39311, Y 39316, Y 39369, Y 39371, Y 39372, Y 39440, Y 39443, Y 39479, Y 39482, Y 39620, Y 39623, Y 41156, Y 41160, Y 41162, Y 41164, Y 41166, Y 41168, Y 41171, Y 41324, Y 41326, Y 41327, Y 41328, Y 41329, Y 41333, Y 41335, Y 41338, Y 41341, Y 41342, Y 41343, Y 41344, Y 41347, Y 41369, Y 41371, Y 41513, Y 41516, Y 41519, Y 41520, Y 41523, Y 41528, Y 41530, Y 41532, Y 41538, Y 41552, Y 41553, Y 41554, Y 41555, Y 41558, Y 41560, Y 41562, Y 41563, Y 41564, Y 41565, Y 41568, Y 41569, Y 41570, Y 41571, Y 41572, Y 41573, Y 41575, Y 41581, Y 41583, Y 41586, Y 43130, Y 43131, Y 43157, Y 44062, Y 44066, Y 44067, Y 44069, Y 44183, Y 44212, Y 44249, Y 44253, Y 44617, Y 44625, Y 44631, Y 44653, Y 44658, Y 44773, Y 44777, Y 45362, Y 46354, Y 46358, Y 46368, Y 46783, Y 46789, Y 46875, Y 46878, Y 47374, Y 47381, Y 47444, Y 47445, Y 47450, Y 47456, Y 47680, Y 47681, Y 47683, Y 47686, Y 47687, Y 47692, Y 47695, Y 47698, Y 47702, Y 47703, Y 48349, Y 48352, Y 48358, Y 48363, Y 49290, Y 49971, Y 72619, Y 72782, Y 74459, Y 74537, Y 74623, Y 74686, Y 76248, Y 87232, Y 87400, X 91132, X 91135, X 91137, X 91161, X 91777, X 97311, X 97317, X 97318, X 97455, X 97492, X 97510, Y 01870, Y 26058, Y 27013, Y 27019, Y 27951, Y 34808, Y 37584, Y 37874, Y 37883, Y 37892, Y 37894, Y 37902, Y 37905, Y 38284, Y 38295, Y 38325, Y 38572, Y 39121, Y 39122, Y 39169, Y 41559, Y 41561, Y 44071, Y 44669, Y 72180, Y 72188, Y 74456, Y 74482, Y 74488, Y 74499, Y 74502, Y 74550, Y 87247, Y 87274, Y 87275, Y 87281, Y 87358, Y 87404, Y 87405, Y 87415, Y 87433, Y 72179, Y 72181, Y 72184, Y 72185, Y 72187, Y 72200, Y 72483, Y 72599, Y 72603, Y 72616, Y 72617, Y 72784, Y 72785, Y 72786, Y 72842, Y 72880, Y 72884, Y 72889, Y 73211, Y 73215, Y 74458, Y 74464, Y 74474, Y 74477, Y 74483, Y 74491, Y 74497, Y 74512, Y 74519, Y 74524, Y 74533, Y 74534, Y 74535, Y 74536, Y 74538, Y 74543, Y 74545, Y 74546, Y 74549, Y 74551, Y 74566, Y 74571, Y 74602, Y 74607, Y 74651, Y 74662, Y 74668, Y 74804, Y 74813, Y 74815, Y 74847, Y 83691, Y 83697, Y 83698, Y 83699, Y 83700, Y 83703, Y 83705, Y 83708, Y 83710, Y 83715, Y 83716, Y 83719, Y 86333, Y 86337, Y 86352, Y 86479, Y 86488, Y 86490, Y 86492, Y 86502, Y 86537, Y 86543, Y 86545, Y 86572, Y 86573, Y 86602, Y 87198, Y 87227, Y 87228, Y 87229, Y 87230, Y 87231, Y 87233, Y 87234, Y 87236, Y 87238, Y 87239, Y 87240, Y 87241, Y 87242, Y 87244, Y 87246, Y 87252, Y 87257, Y 87258, Y 87269, Y 87276, Y 87277, Y 87278, Y 87279, Y 87282, Y 87283, Y 87284, Y 87289, Y 87294, Y 87295, Y 87297, Y 87359, Y 87360, Y 87361, Y 87367, Y 87368, Y 87369, Y 87372, Y 87375, Y 87376, Y 87377, Y 87378, Y 87379, Y 87380, Y 87382, Y 87383, Y 87384, Y 87385, Y 87387, Y 87388, Y 87394, Y 87396, Y 87397, Y 87403, Y 87428, Y 87429, Y 87430, Y 87431, Y 87432, Y 87435, and Y 87436 REASON: Blood products, incorrectly tested for antibodies to human immunodeficiency virus types 1 and 2 (anti-HIV-1/2), hepatitis B surface antigen (HBsAg), or antibodies to human T lymphotropic virus types I and II (anti-HTLV-I/II), were distributed. MANUFACTURER/RECALLING FIRM: Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL RECALLED BY: The recalling firm notified the consignees of the recall by letters dated July 19, 2001, that were delivered by hand and certified mail. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL, IN, FL, NJ, MO, CA, MA, TX, PA, TN, IA and Switzerland QUANTITY: 530 unitsRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1187-1/Z-1188-1 Abbott Cell-Dyn 3200 CS Abbott Cell-Dyn 3200 SL Abbott Cell-Dyn 3200 systems manufactured after 06/23/00 that contain 486-microprocessing chips. List No./Serial Number: Abbott Cell-Dyn 3200 CS 04H59-01 Includes Serial Numbers 29983AH-29993AH Abbott Cell-Dyn 3200 SL 04H60-01 Includes Serial Numbers 60873AF-60906AF CODES: List No./Serial Number: Abbott Cell-Dyn 3200 CS 04H59-01 Includes Serial Numbers 29983AH-29993AH Abbott Cell-Dyn 3200 SL 04H60-01 Includes Serial Numbers 60873AF-60906AF REASON: Analyzers may exhibit fluctuation in hematology results under certain parameters MANUFACTURER: Abbott Diagnostics Division Santa Clara, CA RECALLED BY: Abbott Laboratories, Inc. Santa Clara, CA, on 8/30/00, via telephone and letter. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 45 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1186-1, Architect Free T3 Controls, list 06C48-10; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064; The kit contains 3 bottles (8mL each) of T3 in human serum at the following levels: L = 3.1, M = 6.0, and H = 10.5 pg/mL. Codes:List 06C48-10, lot 62967M300 REASON: High Control concentrations read below package insert specifications MANUFACTURER/RECALLING FIRM: Abbott Laboratories, Inc. Abbott Park, IL RECALLED BY: Recall letters dated 6/28/01 were sent to the direct accounts on 6/28/01 via Federal Express. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, and England, Japan, Hong Kong, Korea, New Zealand, Australia, Canada and Singapore. QUANTITY: 610 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1189-1/Z-1190-1, Pulstar Anti-Embolism Wrap, Codes: Model number Lot Nos. B51558-01, 200194, 200211, 200290, 51558-01, 200218, 200326, 200339, 200346, 201004 REASON: Tearing at the sewn seam of an anti embolism wrap (compression sleeve) MANUFACTURER/RECALLING FIRM: Alba-Waldensian, Inc. Rockwood, TN RECALLED BY: Firm issued recall notifications on 1/17-19/01 via facsimile and first class mail. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: 8258 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1191-1, Adapta MC-100 Massage Chair Codes: Serial Number 1000-1074, manufactured on 9/15/00 REASON: Massage chair frames break under the weight of massage clients MANUFACTURER: Master Home Products Morton Grove, IL RECALLED BY: Chattanooga Group, Inc. Hixton, TN, by telephone and facsimile on 11/10/00 and 12/8/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA, TN, TX, OK, NV, MA and Mexico, South Africa, and Venezuela QUANTITY: 53 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1196-1/Z-1197-1, Pentax brand Video Colonoscopes and Fiber Colonoscopes. The Angle Wire Receptacle component is the affected part. Codes: Video Colonoscopes (510k Model Affected Model # Reference #) EC-3430FK (EC-3800L) EC-3430L (EC-3800L) EC-3430LK (EC-3800L) EC-3440L (EC-3840L) EC-3801L (EC-3800L) EC-3830LK (EC-3800L) EC-3830LZ (EC-3800L) EC-3830TL (EC-3800TL) EC-3830TLK (EC-3800TL) EC-3831L (EC-3800L) EC-3840TL (ORIGINAL) EC-3400F (EC-3800L) EC-3400L (EC-3800L) EC-3800L (ORIGINAL) EC-3800TL (ORIGINAL) EC-3801F (EC-3800L) EC-381L30 (EC-3800L) EC-3830L (EC-3800L) EC-3840L (ORIGINAL) EC-38TL30 (EC-3800TL) Fiber Colonoscopes (510k Model Affected Model # Reference #) FC-34FX (FC-38LX) FC-34LX (FC-38LX) FC-38FH (FC-38LH) FC-38LH (ORIGINAL) FC-38LP (FC-38LH) FC-38LX (ORIGINAL) FC-38LV (FC-38LX) FC-38SX2 (FC-38LX) There are 6 Operator Manuals that support the affected models: Z171 R04, Z207 R04, Z231 R05, Z237 R06, Z242 R05, Z270 R01. Affected Serial Numbers: There are 3019 serial numbers for the distributed units. Please contact CDRH, Pentax or NYK-DO's Recall Coordinator (Downstate) for the serial numbers being recalled. REASON: Angle Wire Connecting Receptacle component was observed to be cracking, resulting in a loss of angulation control for the direction in which the part was applied (up, down). MANUFACTURER: Asahi Optical Co., Ltd. (AOC) Tokyo, Japan RECALLED BY: Pentax Precision Instrument Corporation (PPIC) Orangeburg, NY, by "Corrective Action and Modification" Letters, dated 8/2/01, via Federal Express. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and International QUANTITY: 3019 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1198-1/Z-1199-1 Gemini Hip Stem, Catalog Nos. 1374-12-000 and 1374-13-000 Codes: 1. Gemini hip stem, catalgo # 1374-12-000, lot S55H61. 2. Gemini hip stem, catalog # 1374-13-000, lot S5WHB1. REASON: Incorrect size number etched into hip stems MANUFACTURER/RECALLING FIRM: Depuy Orthopaedics, Inc. Warsaw, IN RECALLED BY: The firm, by telephone on May 7, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: MS, OH, and Canada QUANTITY: 10 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1200-1/Z-1201-1, LCS Total Knee Meniscal Bearing Tibial insert. Codes: 1. LCS total knee meniscal bearing tibial insert, STD, 15 mm. Catalog # 1178-22-025. Lot UF9JH1. 2. LCS total knee meniscal bridging tibial inser, STD+/LG, 12.5 mm. catalog # 1278-25-025. Lot UH3PX1. REASON: Outer boxes labeled with incorrect product code and description MANUFACTURER/RECALLING FIRM: Depuy Orthopaedics, Inc. Warsaw, IN RECALLED BY: Depuy sales representatives were called on October 2 and 3, 2000 and instructed to retrieve the products and return them to Depuy. FIRM INITIATED RECALL: Complete DISTRIBUTION: Germany and Korea QUANTITY: 15 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1202-1, Roche/Hitachi 917 Rack System connected to CLAS. Codes: Roche/Hitachi 917 Rack System connected to CLAS, Catalog number 917100. All systems connected to a CLAS system. REASON: Potential sample/results mismatch MANUFACTURER: Hitachi Instruments Division Iari-ken, Japan RECALLED BY: Roche Diagnostics Corp. Indianapolis, IN, by Urgent Product Correction notice dated October 31, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: IN, NY, SC and TX QUANTITY: 5 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1203-1/Z-1204-1 Split Tissue Protection Sleeve Codes:Product Number 393.745 Lot number 4041562 and Product Number 393-746 Lot number 4044728. REASON: Mislabeled protection sleeves MANUFACTURER: Synthes (USA) West Chester, PA RECALLED BY: Synthes (USA) Paoli, PA, by telephone on 7/25/00 FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: 24 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1205-1, Save-A-Tooth Emergency Tooth Preserving System. The product is shipped in cases of 24 units. A unit is a complete preserving system. The unit is a plastic jar filled with preserving solution. Codes: catalog number Z-12488-1, part number 32-393, lot number 512844 REASON: Product leaking, compromising sterility. MANUFACTURER/RECALLING FIRM: Polysciences, Inc. Warrington, PA RECALLED BY: Save-A-Tooth, Inc. Pottstown, PA, by telephone (date unknown) FIRM INITIATED RECALL: Ongoing DISTRIBUTION: AZ QUANTITY: 417 cases _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1206-1, IMx Glycated Hemoglobin Ion Capture Component Set, list 1A86- 88; the set is composed of the IMx Gylcated Hemoglobin Ion Capture Reagent Pack, list 1A86-20, which contains 1 bottle (10.5 mL) Polyanion Affinity Reagent, 1 bottle (11.1 mL) Lysis Reagent, 1 bottle (10.5 mL) Sorbitol in buffer and 1 bottle (28.0 mL) Wash Buffer, and 1 box (100) Ion Capture Reaction Cells, list 5A57-01; Abbott Laboratories Codes: List 1A86-88, lot numbers 75755M300 and 75779M300 REASON: Imprecise results (low) on patient specimens MANUFACTURER/RECALLING FIRM: Abbott Laboratories, Inc. Abbott Park, IL RECALLED BY: Firm, by letters dated 6/20/00, via express mail FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, and International QUANTITY: 4490 kitsRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0643-1, Freedom60 Tubing Set, 2 mL per hour Intended for use with Freedom60 Syringe Infusion Pump System Individual packaged and sterilized. Sold in boxes of 50. Codes: Lot Number: 1.300/00 Catalog Number: F2ML REASON: Separation of the female luer connector. MANUFACTURER/RECALLING FIRM: Repro-Med Systems, Inc. Chester, NY RECALLED BY: Firm initiated recall by telephone on 4/19/01 requesting return of affected devices. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: CA, PR, OH, KS and TX QUANTITY: 311 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1192-1/Z-1193-1, Sensation Plus Lubricated and Sensation Plus Spermicidal Lubricant, Codes: Product No. Sensation Plus Lubricated: Lot Nos. 0007900889, (Exp 07/2003), 03/99/C (Exp 02/2002), and 02/00/A (Exp 01/2003) REASON: Retail packaging error, condoms were packaged into wrong retail boxes MANUFACTURER: Ansell Healthcare Products, Inc. Dothan, AL RECALLED BY: Ansell Healthcare Products, Inc., Cowansville, QE, between 12/4/00 and 12/11/00 by telephone, and recall notification dated 12/14/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: Canada QUANTITY: 1923 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1194-1, X-SYSTEMS Methadone Controls, list 09676-10; an in-vitro diagnostic used for the verification of calibration of the TDxFLx, TDx or ADx System when used for the semi-quantitative determination of methadone in human urine. Distributed in Europe by Abbott, Germany Codes: List #09676-10, lot 76062Q200, exp. 3/3/02 REASON: Methadone Controls manufactured at methadone concentrations below target value MANUFACTURER: Abbott Health Products, Inc. Barceloneta, PR RECALLED BY: Abbott Laboratories, Inc. Abbott Park, IL, sent recall notifications dated 6/14/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Germany, Hong Kong and Australia QUANTITY: 19 kits _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1195-1, X-SYSTEMS Multiconstituent Controls for Abused Drug Assays, list 09687-12; an in-vitro diagnostic used for the verification of calibration of the Abused Drug assays on the AxSYM, TDxFLx, TDx or ADx Systems. Distributed in Europe by Abbott, Germany Codes: List #09687-12, lots 72409M100, exp. 10/31/01, and 74338M300, exp. 11/30/01. REASON: Methadone Controls manufactured at methadone concentrations below target value MANUFACTURER/RECALLING FIRM: Abbott Laboratories, Inc. Abbott Park, IL RECALLED BY: "Device Correction" letters dated 6/14/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and International. QUANTITY: 1446 kits.END OF ENFORCEMENT REPORT FOR September 26, 2001.
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