FEBRUARY 20, 2002 02-07
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
______________________ PRODUCT Pillsbury Croissants Baked Butter - Curved 96 count, 1 oz. units, Net Wt. 6 LB. Item #94562-04609, Recall # F-287-2. Pillsbury Croissants Margarine Baked Regular Curved (Preformed) Sliced,60 count, 2 oz. units, Net Wt. 7 lB 8 oz., Item #94562-04035, Recall # F-288-2. CODE Date Code on all product: H1B27 H=August, 1=2001, B=Eden Prairie (Plant), 27= Day of Month. Frozen Baked Croissants manufactured on August 27, 2001. Two item codes (same Date Code): #94562-04609 Butter Croissants #94562-04035 Margarine Croissants RECALLING FIRM/MANUFACTURER Recalling Firm: Pillsbury St. Paul, MN, by fax and telephone on Aug. 29, 2001. Manufacturer: Pillsbury Company Eden Prairie, MN. Firm initiated recall is complete. REASON Products contained metal pieces from a clamp that had fallen into dough rework system. VOLUME OF PRODUCT IN COMMERCE 630 cases. DISTRIBUTION MI, IL, KY, WA, WI, MN, ND, IA and TN.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________ PRODUCT a) Lunelle Monthly Contraceptive Injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension), 25 mg/5mg., 0.5 ml vial and 0.5 mL vial as physician sample, Recall # D-193-2; b) Depo-Provera Contraceptive Injection (medroxyprogesterone acetate injectable suspension) 150 mg/ml, 1 ml. vials, For Export. Recall # D-194-2. CODE a) Lot 65HHX; exp. 10/2003 Lot 76HHH; exp. 10/2003; b) Lots 49HHC, 50HHC and 71HHH; exp. 10/2005. RECALLING FIRM/MANUFACTURER Pharmacia Corporation, Kalamazoo, MI, by letters on Feb. 5, 2002. Firm initiated recall is complete. REASON Lack of assurance of sterility. VOLUME OF PRODUCT IN COMMERCE Approx. 400,000 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Tegretol Tablets, (Carbamazepine, USP), 200 mg.; 100 tablet Bottles. Recall # D-195-2. CODE Product #0163-1, lot numbers 9243162 and 9245086. RECALLING FIRM/MANUFACTURER Recalling Firm: Allscripts Healthcare Solutions Libertyville, IL, by telephone on Dec. 19, 2001. Manufacturer: Novartis Pharmaceutical Company East Hanover, NJ. Firm initiated recall is complete. REASON Dissolution failure (by manufacturer) VOLUME OF PRODUCT IN COMMERCE 5 bottles. DISTRIBUTION IA and HI.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT a) Metoclopramide Oral Solution, USP, 5 mg/5 mL dose cups. Recall # D-191-2; b) Metoclopramide Oral Solution, USP, 10 mg/10 mL dose cups. Recall # D-192-2. CODE a) 5 mL unit dose cups: lots 101030, 102015; b) 10 mL unit dose cups: lots 101028, 101029, 101038, 102002, 102016. RECALLING FIRM/MANUFACTURER Recalling Firm: Unit Dose Laboratories Inc., Rockford, IL, by letter dated Jan. 9, 2002. Manufacturer: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL. Firm initiated recall is ongoing. REASON Subpotency (at manufacturing firm). VOLUME OF PRODUCT IN COMMERCE a) 3620 cases of 5 mL cups; b) 8448 cases of 10 mL cups. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
_______________________ PRODUCT Cornea for Transplant, Recall # B-0745-2. CODE Code 01-1893. RECALLING FIRM/MANUFACTURER Georgia Eye Bank, Inc., Atlanta, GA, by telephone on Nov. 21 and by letter dated Nov. 26, 2001. Firm initiated recall is complete. REASON Cornea for transplant was collected from a donor, who tested positive for HIV DNA by PCR testing. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION GeorgiaRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT a) Red Blood Cells, Leukoreduced Unit, Recall # B-0754-2; b) Platelets, Pooled, Recall # B-0755-2; c) Recovered Plasma, Recall # B-0756-2. CODE a) and c) Unit T76442; b) Unit P05695. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by letter on October 2, 2000 or November 1, 2000, and by telephone on November 3, 2000. Firm initiated recall is complete. REASON Blood PRODUCTs, collected from a donor who had received a blood transfusion within one year of donation, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION Wisconsin and Switzerland. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0757-2; b) Recovered Plasma, Recall # B-0758-2. CODE a) and b) Unit FS00406. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by letters dated December 6, 2000 and January 23, 2001. Firm initiated recall is complete. REASON Blood PRODUCTs, collected from a donor with a history of jaundice and hepatitis, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION Wisconsin and Switzerland. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0761-2; b) Recovered Plasma, Recall # B-0762-2. CODE a) and b) Unit FQ26686. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by letter dated August 7 or 16, 2001. Firm initiated recall is complete. REASON Blood PRODUCTs, collected from a donor with a history of hepatitis A, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION Pennsylvania and Switzerland. _______________________ PRODUCT Allergenic Extract Mixtures, non-sterile, Oral Drops, Rx, Recall # B-0774-2. CODE 30-ml plastic dropper bottles lots 17209802, 17280850, 17274807, 17240604, 17270936, 17270302, 17279503, 17252205, 17245907, 17209103, 17279204, 17257704, 17269506, 17217702, 17223203, 17265105, 17252305, 17265005, 17246004, 17226948, 17210720, 17231804, 17209403, 17213106, 17214009, 17226617, 17222713, 17220302, 17222610, 17257608, 17235804, 17265918, 17217605, 17239402, 17226810, 17278827, 17235408, 17268232, 17270805, 17262004, 17232202, 17218102, 17220204, 17257804, 17239008, 17241103, 17208708, 17261904, 17262104, 17262651, 17268105, 17257502, 17252116, 17227205, 17227106, 17248436, 17246105, 17226533, 17222911, 17245510, 17278913, 17208509, 17229909, 17230005, 17268308, 17238828, 17220105, 17219811, 17219906, 17269206, 17208630, 17273923, 17230107, 17279304, 17279808, 17217033, 17265402, 17262501, 17214147, 17270402, 17218002, 17261808, 17220613, 17257130, 17274004, 17235325, 17269367, 17275007, 17262816, 17252005, 17230302, 17245707, 17274611, 17262769, 17257228, 17261609, 17279107, 17269905, 17257039, 17209305, 17236725, 17239302, 17210652, 17268947, 17248505, 17208823, 17264808, 17239602, 17278706, 17278613, 17275204, 17257406, 17274104, 17227304, 17245629, 17242618, 17236817, 17239205, 17220003, 17265603, 17257312, 17265503, 17279006, 17268510, 17230402, 17279727, 17274522, 17261729, 17235604, 17230917, 17282338, 17223304; 15-ml plastic dropper bottles lots 17210101, 17210301, 17210401, 17213901, 17213701, 17213801, 17218201, 17218401, 17230701, 17230801, 17235704, 17236601, 17236501, 17249301, 17249201, 17247201, 17249401, 17247401, 17249501, 17258001, 17262401, 17268801. RECALLING FIRM/MANUFACTURER Allergy Laboratories of Ohio, Inc., Columbus, OH, by letters on December 18 or 20, 2001. Firm initiated recall is complete. REASON Oral allergenic extracts, that were not approved and licensed by FDA, were distributed. VOLUME OF PRODUCT IN COMMERCE 154 vials. DISTRIBUTION OH. _______________________ PRODUCT Platelets, Pheresis, Leukoreduced, Irradiated, Recall # B-0785-2. CODE Unit 32GP16141. RECALLING FIRM/MANUFACTURER Recalling Firm: American Red Cross Blood Services, Badger-Hawkeye Region, Madison, WI, by telephone on May 2, 2001. Manufacturer: Badger - Hawkeye Region-Green Bay Facility, Green Bay WI. Firm initiated recall is complete. REASON Blood product, which had a deceased volume, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IL. _______________________ PRODUCT Platelets, Pheresis, Leukoreduced, Recall # B-0786-2. CODE Units FW14327-1, FW14327-2, LH56931-1. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on February 26 and by letter dated March 20, 2001. Firm initiated recall is complete. REASON Blood products, which were incorrectly labeled due to a low platelet count were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION WI. ___________________ PRODUCT Platelets, Pheresis, Leukoreduced, Recall # B-0787-2. CODE Unit FW07028-1. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on September 17, 2000 and by letter August 22, 2001. Firm initiated recall is complete. REASON Blood product, which was incorrectly labeled due to a low platelet count, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WI. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0788-2 CODE Units 17KP96286, 17KP96288. RECALLING FIRM/MANUFACTURER American Red Cross, North Central Blood Services, St. Paul, MN, by telephone on May 10 and by letter dated May 16, 2001. Firm initiated recall is complete. REASON Blood products, which may have been stored at unacceptable temperatures, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MN. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0789-2; b) Platelets, Recall # B-0790-2; c) Cryoprecipitate, Recall # B-0791-2; d) Plasma, Cryoreduced, Recall B-0792-2; e) Recovered Plasma, Recall # B-0793-2. CODE a) Units 17KR56007, 17KR40871, 17KL35202, 17KX20312; b) Units 17KL35202, 17KX20312; c) and d) Unit 17KR40871; e) Unit 17KR56007, 17KL35202, 17KX20312. RECALLING FIRM/MANUFACTURER American Red Cross, North Central Blood Services, St. Paul, MN, by letter dated August 2, 2000. Firm initiated recall is complete. REASON Blood products, which tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from a donor that previously tested reactive to anti-HCV, were distributed. VOLUME OF PRODUCT IN COMMERCE 11 units. DISTRIBUTION MN, MI and GA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0794-2; b) Red Blood Cells, Leukoreduced, Recall # B-0795-2; c) Platelets, Recall # B-0796-2; d) Fresh Frozen Plasma, Recall # B-0797-2; e) Recovered Plasma, Recall # B-0798-2. CODE a) and d) Unit 17KT09084; b) and e) Units 17KC03116, 17KT19930; c) Units 17KT19930, 17KT09084. RECALLING FIRM/MANUFACTURER American Red Cross, North Central Blood Services, St. Paul, MN, by letter dated April 4, 2001. Firm initiated recall is complete. REASON Blood products, which tested negative for the antibody to the human immunodeficiency virus (HIV), but were collected from a donor who previously tested repeatedly reactive for the HIV. antibody, were distributed. VOLUME OF PRODUCT IN COMMERCE 8 units. DISTRIBUTION MN, IL and WI. _______________________ PRODUCT Platelets, Pheresis, Leukocytes Reduced, Recall # B-0804-2. CODE Unit KZ57493 (split unit). RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on January 11 and by letter January 15, 2001. Firm initiated recall is complete. REASON Blood product, which was labeled as leukoreduced, but did not meet the requirements for a leukoreduced product, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WI. _______________________ PRODUCT Platelets, Pheresis, Leukocytes Reduced, Recall # B-0820-2. CODE Unit 42KF06270 - split PRODUCT RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH, by telephone on October 19, 2001. Firm initiated recall is complete. REASON Split product, corresponding to a unit of Platelets that were implicated in a transfusion reaction and found to be contaminated with Staphylococcus auricularis, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OH. _______________________ PRODUCT Fresh Frozen Plasma, Pheresis, Irradiated, Recall # B-0825-2. CODE Units 0600122, 0600155, 0600150, 0600168, 0600153, 0600141, 0600151, 0600055, 0600142, 0600169, 0600112, 0600159, 0600146, 0589385, 0600152, 0600156, 0600161, 0600162, 0600148, 0600059. RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, Cincinnati, OH, by fax on August 24, 2001, and by letter on November 29, 2001. Firm initiated recall is complete. REASON Blood products, labeled with extended expiration dates, were distributed. VOLUME OF PRODUCT IN COMMERCE 20 units. DISTRIBUTION OH. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0826-2; b) Platelets, Leukoreduced, Recall # B-0827-2. CODE a) and b) Unit 17KE04104. RECALLING FIRM/MANUFACTURER American Red Cross, North Central Blood Services, St. Paul, MN, by letter dated September 20, 2000. 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 2 units. DISTRIBUTION MN and CT. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0828-2. CODE Unit 17KH96017. RECALLING FIRM/MANUFACTURER American Red Cross, North Central Blood Services, St. Paul, MN, by letter dated September 20, 2000. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0830-2; b) Recovered Plasma, Recall # B-0831-2. CODE a) and b) Unit 32FT06261. RECALLING FIRM/MANUFACTURER Recalling Firm: American Red Cross, Badger-Hawkeye Region, Madison, WI, by letter dated September 21, 1999. Manufacturer: American Red Cross, Badger-Hawkeye Region - Waterloo Facility, Waterloo, IA. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of having tested positive for Hepatitis C, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION AK. _______________________ PRODUCT Red Blood Cells, Recall # B-0833-2. CODE Unit 19242-6855. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letters dated May 4 and 29, 2001. Manufacturer: United Blood Services, Reno, NV. Firm initiated recall is complete. REASON Blood product, collected from a donor with a history of having tested positive for Hepatitis B, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NV. _______________________ PRODUCT Platelets, Pheresis, Leukoreduced, Irradiated, Recall # B-0834-2. CODE Unit 19241-2247. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on February 18 and by letter July 13, 2001. Manufacturer: United Blood Services, Reno, NV. Firm initiated recall is complete. REASON Blood product, collected from a donor who on two occasions tested positive for Hepatitis B core antibody, (anti-HBc), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NV. ______________________ PRODUCT a Red Blood Cells, Recall # B-0838-2; b) Platelets, Recall # B-0839-2 c) Cryoprecipitated AHF, Recall # B-0840-2; d Cryoprecipitated AHF, Pooled, Recall # B-0841-2; e) Fresh Frozen Plasma, Recall # B-0842-2; d) Plasma, Recall # B-0843-2; e) Red Blood Cells for Further Manufacturing Use, Recall # B-0844-2; f) Recovered Plasma, Recall # B-0845-2. CODE a) Unit numbers 17KJ65323, 17KJ04863, 17GJ49102, and 17GJ38181; b) Unit numbers 17GJ08248, 17GJ89892, 17GJ86267, 17GJ80638 and 17GJ38181; c) Unit number 17GJ49102; d) Pool number 2624; e) Unit numbers 17GJ80638, 17GJ53408 and 17GJ38181; f) Unit number 17KJ86641; g) Unit numbers 17KJ86641, 17GJ08248, 17GJ89892, 17GJ86267, 17GJ80638 and 17GJ53408; e) Unit numbers 17KJ65323, 17KJ09823, 17KJ04863, 17GJ08248, 17GJ89892, 17GJ86267 and 17GJ49102. RECALLING FIRM/MANUFACTURER The American National Red Cross, North Central Region, St. Paul, MN, by telephone on July 14 and 18 and by letters dated July 20 and 26, 2000, and August 31., 2000. Firm initiated recall is complete. REASON Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from a donor that previously tested repeatedly reactive for anti-HCV, were distributed. VOLUME OF PRODUCT IN COMMERCE 28 units. DISTRIBUTION MN, MA, CA, PA, KS, NJ and Switzerland. _______________________ PRODUCT Platelets, Recall # B-0846-2. CODE Unit 2116727. RECALLING FIRM/MANUFACTURER LifeShare, Inc., Elyria, OH, by letter dated December 6, 2001. Firm initiated recall is complete. REASON A unit of Platelets, which was prepared from a unit collected from a donor who had taken aspirin within three days of donation, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OH. _______________________ PRODUCT Platelets, Recall # B-0847-2. CODE Units 2116706, 2116709. RECALLING FIRM/MANUFACTURER LifeShare, Inc., Elyria, OH, by letter dated December 4, 2001. Firm initiated recall is complete. REASON Platelets, for which there was no documentation to determine if the rest time was adequate, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OH. ______________________ PRODUCT Red Blood Cells, Recall # B-0849-2. CODE Unit number 50F88339. RECALLING FIRM/MANUFACTURER The American National Red Cross, Western Lake Erie Region, Toledo, OH, by letter dated October 4, 2000. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OH. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-0850-2. CODE Unit numbers 92222921A and 92222921B. RECALLING FIRM/MANUFACTURER Coral Blood Services, Inc., Scarborough, ME, by telephone on or about June 13 and by letter dated June 25, 2001. Firm initiated recall is complete. REASON Blood products, that were labeled leukoreduced but had an elevated white blood cell count, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION ME. _______________________ PRODUCT Immuno-US Albumin (Human) Solution 25%, 20ml, Recall # B—853-2. CODE Lot 428801A. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corporation, Glendale, CA, by telephone and letter on February 9, 2000. Firm initiated recall is complete. REASON Albumin product, reprocessed with an unvalidated procedure, was distributed. VOLUME OF PRODUCT IN COMMERCE 175 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0859-2. CODE Unit number 12GR03538. RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by letter dated November 6, 2001. Manufacturer: The American National Red Cross, Winston-Salem, NC. Firm initiated recall is complete. REASON Blood product, collected from an ineligible donor due to the disease scleroderma, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NC.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Platelets, Recall # B-0766-2. CODE Units 32KQ68267, 32KE31554, 32KE31570, 32KE31564, 32KE31565, 32KE31566, 32KE31569, 32KQ68236, 32KQ68237, 32KQ68238, 32KQ68239, 32KQ68242, 32KQ68243, 32KQ68245, 32KQ68247, 32KQ68248, 32KQ68249, 32KQ68234, 32KQ68235, 32KE31552, 32KE31553, 32KQ68240, 32KQ68241, 32KQ68250, 32KQ68252, 32KQ68253, 32KQ68254, 32KQ68256, 32KQ68257, 32KQ68259, 32KQ68260, 32KQ68261, 32KQ68262, 32KQ68264, 32KQ68268, 32KQ68270, 32KQ68272, 32KE31559. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Badger-Hawkeye Region, Madison, WI, by telephone on December 14 and by letter dated December 28, 2000. Firm initiated recall is complete. REASON Platelets, that had been stored at temperatures above the acceptable range, were distributed. VOLUME OF PRODUCT IN COMMERCE 38 units. DISTRIBUTION WI. ________________________ PRODUCT Cornea for Transplant, Recall # B-0771-2. CODE Id. Numbers: 2001-12-244L and 2001-12-244R. RECALLING FIRM/MANUFACTURER Northeast Pennsylvania Lions Eye Bank, Allentown, PA, by telephone on December 21, 2001. Firm initiated recall is complete. REASON Corneas for transplant were collected from a donor who tested repeatedly reactive for Hepatitis B Surface Antigen (HBsAg); confirmatory testing was non-confirmable by neutralization. VOLUME OF PRODUCT IN COMMERCE 2 corneas. DISTRIBUTION PA. _______________________ PRODUCT Platelets, Pheresis, Leukoreduced, Recall # B-0778-2. CODE (Split unit), Unit 17FX38316. RECALLING FIRM/MANUFACTURER American Red Cross, North Central Blood Services, St. Paul, MN, by telephone on December 28, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor whose arm inspection and skin disease status had not been accurately documented, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MN. _______________________ PRODUCT Recovered Plasma, Recall # B-0800-2. CODE Units 17KH90385, 17KK90974, 17KK95121. RECALLING FIRM/MANUFACTURER American Red Cross, North Central Blood Services, St. Paul, MN, by questionable plasma inquiry on December 7, 2000 and January 4, 2001. Firm initiated recall is complete. REASON Blood products, collected from donors who had received Heptavax within seven days of donation, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0801-2; b) Platelets, Recall # B-0802-2; c) Recovered Plasma, Recall # B-0803-2. CODE a), b) and c) Unit 17K54480. RECALLING FIRM/MANUFACTURER American Red Cross, North Central Blood Services, St. Paul, MN, by letter dated February 27, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with an acceptable ALT, but who had previous ALT elevations on two separate occasions, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION MN. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0805-2. CODE Units 32KF98597, 32KF98607. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Badger-Hawkeye Region, Madison, WI, by telephone on August 14, 2001. Firm initiated recall is complete. REASON Red Blood Cells, manufactured with a hematocrit greater than 80%, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION WI. _______________________ PRODUCT Washed Red Blood Cells, Leukocytes Reduced, Recall # B-0806-2. CODE Unit 17KY30577. RECALLING FIRM/MANUFACTURER American Red Cross, North Central Blood Services, St. Paul, MN, by letter dated May 17, 2000. Firm initiated recall is complete. REASON Red Blood Cells, that failed RBC recovery ratio, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MN. _______________________ PRODUCT Whole Blood Unit, Recall # B-0832-2. CODE Unit 19246-8917. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on August 17, 2001. Manufacturer: United Blood Services, Reno, NV. Firm initiated recall is complete. REASON Blood product, labeled with an extended expiration date, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NV. _______________________ PRODUCT pHix, Phosphate Buffer Concentrate, Recall #B-0856-2. CODE Lot # 1B3832. RECALLING FIRM/MANUFACTURER Immucor, Norcross, GA, by letters dated September 7, 2001 and September 10, 2001. Firm initiated recall is complete. REASON Products, found to have an extended expiration date, subsequent to release, were distributed. VOLUME OF PRODUCT IN COMMERCE 1364 units. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0860-2. CODE Unit numbers 12FK42073, 12FK42083, 12FK42108, 12FK42109, 12FK42115, 12FZ00706, 12M12049, 12LW63887, 12LN29576, and 12KM68546 RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on October 16 and by letter dated October 26, 2001. Manufacturer: The American National Red Cross, Durham, NC. Firm initiated recall is complete. REASON Blood products, that were not leukoreduced within the appropriate time period from collection, were distributed. VOLUME OF PRODUCT IN COMMERCE 10 units. DISTRIBUTION NC.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
_______________________ PRODUCT Solar 9500 Physiological ECG monitor, Recall # Z-0429-2. CODE Serial Numbers: C1MU1460G, D1MU1469G, D1MU1470G, D1MU1471G, D1MU1474G, D1MU1475G, D1MU1476G, D1MU1477G, D1MU1478G, D1MU1480G, D1MU1487G, D1MU1489G, D1MU1492G, D1MU1494G, D1MU1498G, D1MU1499G, D1MU1503G, D1MU1506G, D1MU1508G, D1MU1509G, D1MU1510G, D1MU1516G, D1MU1518G, D1MU1519G, D1MU1520G, D1MU1523G, E1MU1525G, E1MU1526G, E1MU1527G, E1MU1529G, E1MU1530G, E1MU1535G, E1MU1538G, E1MU1539G, E1MU1541G, E1MU1544G, E1MU1547G, E1MU1548G, E1MU1564G, F1MU1566G, F1MU1569G, F1MU1571G, F1MU1572G, F1MU1577G, F1MU1580G, F1MU1583G, F1MU1588G, F1MU1589G, F1MU1591G, F1MU1594G, G1MU1596G, G1MU1597G, G1MU1598G, G1MU1601GMU, G1MU1602GMU, NB1643428, NB1664094, NB1664099, NB1664109, NB1664113, NB1664117, NB1672800, NB1672802, NB1672823, NB1672832, NB1672840, NB1734988, NB1734990, NB1734997, NB1743637, B1743638, NB1743639, NB1743640, NB1743666, NB1786821, NB1786822, NB1786826, NB1786827, NB1786828, NB1786832, NB1786838, NB1807559. RECALLING FIRM/MANUFACTURER GE Medical Systems, Information Technologies Milwaukee, WI, by letter dated July 20, 2001. REASON The installation of incorrect chips could result in device failure. VOLUME OF PRODUCT IN COMMERCE 73 Monitors. DISTRIBUTION CO, IA, IL, MS, OH, TN, TX, WI and Belgium, Denmark, France and the Netherlands.END OF ENFORCEMENT REPORT FOR FEBRUARY 20, 2002 ####
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