May 23, 2001 01-20RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT: a) Schneider String Cheese (Mozzarella Cheese), Net Wt. 8 oz. and Net Wt. 16 oz. b) Midwest Pride Mozzarella String Cheese, Net Wt. 16 oz., distributed by Midewest Pride, Inc. P.O. Box 202, St. Michael, MN 55376. Recall #F- 414-1 CODE: String Cheese with a sell by date of May 05 01. MANUFACTURER: Schneider Cheese, Inc., Waldo, WI. RECALLED BY: Manufacturer, by telephone and letter on December 8, 2000, and by press release December 11, 2000. Completed recall resulted from analysis by the Minnesota Department of Agriculture. DISTRIBUTION: MN, OH, OK, WI. QUANTITY: 8688 lbs. REASON: The product was contaminated with Listeria monocytogenes.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
__________ PRODUCT: Blue Luna Cafe Nachos 'n' Cheese Dip Combo Snack Tray Total Net Wt. 6 Oz. (contains 2.75 ounces of corn chips and 3.25 ounces cheese dip), manufactured for Blue Luna Cafe, Lake Success, NY. Recall #F-387-1. CODE: All lots. MANUFACTURER: M.A. Gedney Co., Chaska , MN RECALLED BY: Manufacturer, by letter and telephone on February 6, 2001. Firm- initiated recall completed. DISTRIBUTION: FL and NY. QUANTITY: About 6000 cases (24 packages per case) were estimated to be in distribution at the time the recall was initiated. REASON: The product contained undeclared FD&C Yellow No. 5. PRODUCT: Sinbad brand sweets packed in plastic containers varies sizes from 8 oz. to 7 lbs: (1) European Fillo Dough F-388-1 (2) Baklava Assortment F-389-1 (3) Mini Baklava Assortment F-390-1 (4) Classic Baklava F-391-1 (5) Mini Classic Baklava F-392-1 (6) Baklava Ensemble F-393-1 (7) Strudels F-394-1 (8) Tarts (Peanut Butter, Nut, Chocolate Chips) F-395-1 (9) Mini Chocolate Baklava F-396-1 (10) Chocolate Almond Baklava F-397-1 (11) Cappucino Baklava F-398-1 (12) Cafe Sweets F-399-1 (13) Baklava Collection F-400-1 (14) Marquis Baklava F-401-1 (15) Large Fillo Shells F-402-1 The fillo dough are in 16 oz. boxes, 24 boxes to a case. The unit size of the other products are custom packed by customers and varies from 8 oz. to 7 lbs. CODE Not coded - (all products on the market at the time the recall was initiated were implicated). MANUFACTURER: Sinbad Sweets, Inc., Fresno, CA RECALLED BY: Manufacturer, by phone on or about December 19, 2000, and by letter on January 7, 2001. DISTRIBUTION Nationwide QUANTITY About 990,000 lbs. REASON The products contain an undeclared whey ingredient.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT: Discount Drug Mart Food Fair brand Stool Softener (OTC) Docusate Sodium, 100 mg, 100 capsules (softgels) bottles Recall#D-214-1. CODE: Lot J043, expiration date 12/2001. MANUFACTURER: PL Developments, Farmingdale, NY. RECALLED BY: PL Developments by letter on 4/05/2001. Firm initiated recall is ongoing. DISTRIBUTION: OHIO QUANTITY: 1440 units were distributed to the Own Label Distributor. Firm estimates that approximately 562 bottles remain in commerce. REASON: Mispackaging; Bottles of Stimulant Laxative Plus Stool Softener (Casanthranol and Docusate Sodium ) were erroneously packaged into unit cartons labeled only as a Stool Softener (Docusate Sodium). ________ PRODUCT: a) Oxygen, U.S.P., high pressure cylinders,various sizes. Recall #D-211-1; b) Oxygen, USP, liquid, in HLD's. Recall #D-212-1. CODES: Lot Number Cylinder Sizes 536-3059-80 0102 K, M, Q, T 536-3149-82 0101 K, M, Q 536-3239-85 0102 K, M 536-3349-87 0102 K 536-3369-88 0102 K, M, T 536-3419-88 0102 K 536-3429-89 0102 K, M, T 536-3549-91 0101 E, K, M, Q 536-3569-91 0102 K, M, Q 536-3629-93 0101 K 536-0880-19 0603 B, D, E 536-0880-19 0604 E 536-1390-30 0101 K, M, Q 536-2300-48 01 190 liters-HLD 536-2500-51 01 190 liters-HLD 536-2520-52 01 160 liters MANUFACTURER: P.G. Walker, 1405 Walnut St, Springfield, MO. 65806 RECALLED BY: P.G. Walker, by letter dated 10/20/00 The recall is complete. DISTRIBUTION: MO, OK, TN, AR, KS, TX, and IN. QUANTITY: The firm distributed 587 cylinders of varying sizes REASON: Current good manufacturing practice (CGMP)deviations, including but not limited to finished products assays missing from production records.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT: a) Geneva Tretinoin Gel, USP, 0.025%, NDC 0781-7061-27, Batch #PMIP NET WT. 15 G b) Geneva Tretinoin Gel, USP, 0.025%, NDC 0781-7061-19, Batch #PMIP-1 NEW WT. 45 G Recall#D-213-1 CODE: (15 gm) Batch # PMIP, Exp 11/02; (45 gm) Batch # PMIP-1, Exp 11/02. MANUFACTURER: DPT LABORATORIES, SAN ANTONIO,TX. RECALLED BY: SPEAR PHARMACEUTICALS, TITUSVILLE, FL., on 4/30/2001 by letter. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 12,336 bottles of 15gm; 15,852 bottles of 45gm. REASON: VISCOSITY FAILURE, (3 MONTH STABILITY STATION). ________ PRODUCT: Children's Mylanta Upset Stomach Relief (Calcium Carbonate Antacid), 5 oz liquid bottles. The product is shipped 12 bottles per shipper. Recall #D-201-1. CODE: DCF 033 exp. 2/02, DCF 060 exp. 3/02, DEF 044 exp. 4/02, DEF 134 exp. 4/02, DEF 047 exp. 5/02, DHF 023 exp. 6/02, DJF 066 exp. 7/02, DJF 118 exp. 7/02, DJF 123 exp. 7/02, DPF 042 exp. 10/02, DSF 032 exp. 11/02, EAF 011 exp. 12/02, EBF 049 exp. 1/03 and EBF 071 exp. 1/03. MANUFACTURER: Johnson & Johnson Merck Consumer Pharmaceuticals Company, Lancaster,PA. RECALLED BY: Johnson & Johnson Merck Consumer Pharmaceuticals Company, Fort Washington, PA. by recall letter dated 4/23/00 The recall is ongoing. DISTRIBUTION: Nationwide QUANTITY: 770,000 bottles. REASON: FAILURE TO PERFORM MICROBIOLOGICAL TESTING AS PER THE USP ANTIMICROBIAL EFFECTIVENESS TEST METHOD.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
"UPDATE/CORRECTION: Recall#B-780-1 was incorrectly classified. Upon review we have determined that our initial classfication dated February 23, 2001 was incorrect. This recall has been reclassified as Class III. ________ PRODUCT: a) Red Blood Cells. Recall# B-1044-1. b) Recovered Plasma. Recall#B-1045-1. CODE: a) Unit 04W97487; b) Unit 04W97487. MANUFACTURER: American Red Cross Dedham, MA. RECALLED BY: Manufacturer, by letter dated September 11, 2000, and was informed that the Red Blood Cells had been transfused. Firm initiated recall complete. DISTRIBUTION: MA and CA. QUANTITY: Two units. REASON: Blood products collected from a donor with a history of having tested positive for hepatitis were distributed. ________ PRODUCT: a) Red Blood Cells. Recall# B-1047-1. b) Red Blood Cells, Leukoreduced. Recall# B-1048-1. c) Platelets. Recall# B-1049-1. d) Recovered Plasma. Recall# B-1050-1. CODE: a) Units 29FN33010, 29KN19318; b) Unit 29KH22383; c) Units 29FN33010, 29KN19318; d) Units 29FN33010, 29KN19318, 29KH22383. MANUFACTURER: American Red Cross, Norfolk, VA. RECALLED BY: Manufacturer, by letters dated September 13, 2000 and October 13, 2000. Firm initiated recall complete. DISTRIBUTION: NC,PA,VA. QUANTITY: 8 units. REASON: Blood products, collected from a donor with a history of jaundice, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall#B-1051-1. b) Plasma. Recall#B-1052-1. c) Recovered Plasma. Recall#B-1053-1. CODE: a) Units 29KL18813, 29KM10714; b) Unit 29KL18813; c) Unit 29KM10714. MANUFACTURER: American Red Cross Norfolk, VA. RECALLED BY: Manufacturer, by letters dated September 1, 2000 and a questionable Plasma Inquiry on September 8, 2000, which they in turn forwarded to the California consignee of the Recovered Plasma on September 12, 2000. The recall is complete. DISTRIBUTION: NC and VA. QUANTITY: 4 units. REASON: Blood products collected from a donor with a history of jaundice were distributed. Firm initiated recall complete. ________ PRODUCT: Platelets. Recall#B-1057-1. CODE: Units 18S61908, 18S61949. MANUFACTURER: American Red Cross Blood Services, Lansing, MI. RECALLED BY: Manufacturer, by letter on February 23, 2000. Firm initiated recall is complete. DISTRIBUTION: MI. QUANTITY: 2 units. REASON: Blood products, collected from donor who had been exposed to Hepatitis A, were distributed. ________ PRODUCT: a) Red Blood Cells. B-1058-1. b) Cryoprecipitate. B-1059-1. c) Recovered Plasma. B-1060-1. CODE: a) Unit 42K04221; b) Unit 42K04221; c) Unit 42K04221. MANUFACTURER: American Red Cross Blood Services, Northern Ohio Region, Cleveland. RECALLED BY: Manufacturer, by letters dated August 25, 2000, and September 27, 2000. Firm initiated recall complete. DISTRIBUTION: OH. QUANTITY: 3 units. REASON: Blood products, collected from a donor with a history of having tested positive for hepatitis, were distributed. ________ PRODUCT: Platelet Concentrate. Recall #B-1063-1. CODE: Units G00431, G00432, G00433, G00434. MANUFACTURER: Merced County Blood Bank, Merced, CA. RECALLED BY: Manufacturer, by telephone on July 22, 1999. Firm initiated recall is complete. DISTRIBUTION: CA. QUANTITY. 4 units. REASON: Blood products, which were exposed to room temperature for an unacceptable resting time, were distributed. ________ PRODUCT: Source Plasma. Recall #B-1066-1. CODE: Unit 7050104850. MANUFACTURER: Nabi Biomedical center, Fort Collins, CO. RECALLED BY: Manufacturer, by fax on August 11, 2000. Firm initiated recall complete. DISTRIBUTION: England. QUANTITY: 1 unit. REASON: Blood products, which was contaminated with saline prior to testing, was distributed. _______ PRODUCT: Red Blood Cells. Recall#B-1067. CODE: Unit 16KG02935. MANUFACTURER: American Red Cross Blood Services Columbus, OH. RECALLED BY: Manufacturer, by telephone on January 12, 2001. Firm initiated recall is complete. DISTRIBUTION: OH. QUANTITY: 1 unit. REASON: Blood product, collected in a manner that may have compromised the sterility of the unit, was distributed. ________ PRODUCT: Platelets, Pheresis. Recall #B-1068-1. CODE: Unit 0561084. MANUFACTURER: Hoxworth Blood Center, Cincinnati, OH. RECALLED BY: Manufacturer, by letter dated march 8, 2001. Firm initiated recall complete. DISTRIBUTION: OH. QUANTITY: 1 unit. REASON: Blood product, which had an unacceptable platelet count, was distributed. _______ PRODUCT: Platelets, Pheresis, Leukoreduced. Recall #B-1069-1. CODE: Unit 9026800. MANUFACTURER: Medic Regional Blood Center, Knoxville, TN. RECALLED BY: Manufacturer, by letter dated November 10, 1998. Firm initiated recall complete. DISTRIBUTION: TN. QUANTITY: 1 unit. REASON: Blood product, which had an unacceptable platelet count, was distributed. ________ PRODUCT: Source Plasma. Recall #B-1072-1. CODE: Units G-06547-009, G-16666-009, G-16271-009. MANUFACTURER: Alpha Therapeutic Corporation,Tacoma, WA. RECALLED BY: Manufacturer, notified by facsimiles on 1/5/99. Firm initiated recall is complete. DISTRIBUTION: CA. QUANTITY: 3 units. REASON: Blood products, which were not quarantined after receiving information concerning a post donation illness, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-1082-1; b) Fresh Frozen Plasma, Divided. Recall #B-1083-1. CODE: a) Units 19GF69485, 19GF62246; b) Units 19GF69485 (3 units), 19GF62246 (3 units). MANUFACTURER: American Red Cross Blood Services Nashville, TN. RECALLED BY: Manufacturer, by letters dated March 14, 2000. Firm initiated recall complete. DISTRIBUTION: TN. QUANTITY: 8 units. REASON: Blood products, collected from a donor who had engaged in high-risk behaviors, were distributed. ________ PRODUCT: Red Blood Cells, Leukoreduced. Recall #B-1084-1. CODE: Unit 19LF17367 MANUFACTURER: American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN. RECALLED BY: Manufacturer, by telephone on July 24, 2000. Firm-initiated recall complete. DISTRIBUTION: TN. QUANTITY: 1 unit. REASON: Blood product, prepared from an overweight whole blood unit, was distributed. ________ PRODUCT: Platelets, Pheresis, Leukocytes Reduced. Recall #B-1120-1. CODE: Unit 19GL31539. MANUFACTURER: American Red Cross Blood Services, Tennessee Valley Region,Nashville, TN. RECALLED BY: Manufacturer, by telephone on May 22, 2000. Firm initiated recall complete. DISTRIBUTION: TN. QUANTITY: 1 unit. REASON: Blood product, with a decreased platelet yield, was distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-1113-1. b) Platelets. Recall #B-1114-1. c) Fresh Frozen Plasma. Recall #B-1115-1. CODE: a) Unit 2203768; b) Unit 2203768; c) Unit 2203768. MANUFACTURER: LifeShare, Inc., Elyria, OH. RECALLED BY: Manufacturer, by letters dated December 12, 2000. Firm initiated recall complete. DISTRIBUTION: OH. QUANTITY: 3 units. REASON: Blood products, collected from a donor taking Actonel, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-1120-1; b) Platelets. Recall #B-1121-1; c) Recovered Plasma. Recall #B-1122-1. CODE: a) Unit 2100700; b) Unit 2100700; c) Unit 2100700. MANUFACTURER: LifeShare, Inc, Elyria, Ohio. RECALLED BY: Manufacturer by letter, dated February 6, 2001. Firm initiated recall complete. DISTRIBUTION: OH, TX, FL QUANTITY: 3 units. REASON: Blood products, collected from a donor taking the drug Neurontin, were distributed. ________ PRODUCT: Source Plasma. Recall #B-1145-1. CODE: Unit 19888736. MANUFACTURER: Sera-Tec Biologicals Limited Partnership Denton, Texas. RECALLED BY: Manufacturer by letter dated February 14, 2000. Firm initiated recall complete. DISTRIBUTION: CA. QUANTITY: 1 unit. REASON: Blood product, with a two times elevated ALT level, was distributed for further manufacture. ________ PRODUCT: Corneas. Recall #B-1156-1. CODE: Units 2001-03-1005, 2001-03-1006 MANUFACTURER: Heartland Lions Eye Banks, Columbia, MO. RECALLED BY: Manufacturer, by telephone on March 12, 2001 or March 13, 2001, and by letters dated March 12, 2001 or March 19, 2001. Firm-initiated recall complete. DISTRIBUTION: FL and KS. QUANTITY: 2 units. REASON: Corneas, collected from a donor that tested repeatedly reactive for HIV-1 p24 antigen with a subsequent indeterminate confirmation test, were distributed. ________ PRODUCT: Platelets, Pheresis. Recall #B-1176-1. CODE: Units 7501471, 7375934. MANUFACTURER: Oklahoma Blood Institute, Oklahoma City. RECALLED BY: Manufacturer, by facsimile on February 2, 1999. Firm-initiated recall complete. DISTRIBUTION: TX. QUANTITY: 2 units. REASON: Blood products, collected from a donor with a history of having Hepatitis A, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-1177-1; b) Recovered Plasma. Recall #B-1178-1. CODE: a) Unit 5010193; b) Unit 5010193. MANUFACTURER: Carter BloodCare, Bedford, TX. RECALLED BY: Manufacturer, by letter or facsimile on September 13, 2000. Firm initiated recall complete. DISTRIBUTION: TX and Switzerland. QUANTITY: 2 units. REASON: Blood products, which tested negative for HBsAg, but were collected from a donor who previously tested repeatedly reactive for HBsAg, with no confirmatory testing, were distributed. ________ PRODUCT: Platelets Pheresis, Leukocytes Reduced, Split. Recall #B-1181-1. CODE: Unit 3843101. MANUFACTURER: Gulf Coast Regional Blood Center Houston, TX. RECALLED BY: Manufacturer, by facsimile on June 7, 2000. Firm-initiated recall complete. DISTRIBUTION: TX. QUANTITY: 1 unit. REASON: Blood products, which were labeled as leukoreduced, but failed to meet the criteria for a leuko-reduced product, were distributed. ________ PRODUCT: a) Red Blood Cells, Leukocytes Reduced. Recall #B-1182-1; b) Platelets. Recall #B-1183-1; c) Source Leukocytes. Recall #B-1184-1. CODE: a) Unit 3833759; b) Unit 3833759; c) Unit 3833759. MANUFACTURER: Gulf Coast Regional Blood Center Houston, TX. RECALLED BY: Manufacturer by facsimiles on May 5, 2000. Firm-initiated recall complete. DISTRIBUTION: TX and NJ. QUANTITY: 3 units. REASON: Blood products, collected from a donor who had been deferred by another blood bank, were distributed. _______ PRODUCT: Red Blood Cells, Leukoreduced. Recall #B-1185-1. CODE: Unit 1732709. MANUFACTURER: South Texas Blood & Tissue Center San Antonio, TX. RECALLED BY: Manufacturer, by facsimile on September 12, 2000. Firm-initiated recall complete. DISTRIBUTION: TX. QUANTITY: 1 unit. REASON: Blood product, which was labeled as leukoreduced but did not undergo leukoreduction, was distributed. _______ PRODUCT: a) Red Blood Cells. Recall #B-1196-1; b) Platelets. Recall #B-1197-1. CODES: a) Unit 1704528; b) Unit 1704528. MANUFACTURER: Central Kentucky Blood Center, Lexington, KY. RECALLED BY: Manufacturer, by letters dated January 26, 2001, or February 14, 2001. The recall is complete. DISTRIBUTION: KY. QUANTITY: 2 units. REASON: Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed. _______ PRODUCT: Red Blood Cells. Recall #B-1219-1. CODE: Unit 8035354. MANUFACTURER: Oklahoma Blood Institute, Oklahoma City, Oklahoma. RECALLED BY: Manufacturer, by fax transmissions dated July 10, 1998, and May 24, 1999. Firm initiated recall is complete. DISTRIBUTION: MO. QUANTITY: 1 unit. REASON: Blood product, quarantined due to post donation information of vomiting and diarrhea, was subsequently distributed. _______ PRODUCT: a) Red Blood Cells. Recall #B-1220-1; b) Recovered Plasma. Recall #B-1221-1. CODES: a) Unit 49GR28195; b) Unit 49GR28195. MANUFACTURER: American Red Cross Blood Services, Farmers Branch, TX. RECALLED BY: Manufacturer, by letter dated May 26,2000 and a ìQuestionable Plasma Inquiryî on May 19, 2000. Firm initiated recall complete. DISTRIBUTION: Texas and Switzerland. QUANTITY: 2 units. REASON: Blood products, collected from a donor with a history of hepatitis A, were distributed. _______ PRODUCT: Platelets, Pheresis. Recall #B-1222-1. CODES: Unit 49P50928. MANUFACTURER: The American National Red Cross, Tulsa, OK. RECALLED BY: Manufacturer, by telephone on August 11, 2000, and by letter dated August 25, 2000. Firm initiated recall complete. DISTRIBUTION: OK. QUANTITY: 1 unit. REASON: Platelets Pheresis with an decreased volume were distributed. _______ PRODUCT: Source Plasma. Recall #B-1223-1. CODES: Unit number G-51384-181. MANUFACTURER: Pyramid Biological Corporation, Van Nuys, CA. RECALLED BY: Manufacturer, by letter on March 30, 1999. Firm-initiated recall complete. DISTRIBUTION: CA. QUANTITY: 1 unit. REASON: Blood product, that tested repeatedly reactive for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), was distributed. _______ PRODUCT: Platelets Pheresis. Recall #B-1229-1. CODES: Unit numbers 16KF24746, 16KF24747, 16KF24748, 16KF24749, 16KF24751, 16KF24752, 16KF24754, 16KF24756, 16KF24757, 16KF24758, 16KF24761, 16KF24762, 16KF24763, 16KF24764, 16KF24765, 16KF24766, 16KF24767, 16KF24768, 16KF24769, 16KF24770, 16KF24771, 16KF24772, 16KF24773, 16KF24774, 16KF24777, 16KF24778, 16KF24779, 16KF24780, 16KF24781, 16KF24784, 16KF24787, 16KF24789, 16KF24790, 16KF24791, 16KF24792, 16KF24793, 16KF24794, 16KF24795, 16KF24797, 16KF24798, 16KF24799, 16KF24800, 16KF24801, 16KF24803, 16KF24804, 16KF24805, 16KF24806, 16KF24807, 16KF24808, 16KF24809, 16KF24811, 16KF24813, 16KF24814, 16KF24815, 16KF24816, 16KF24818, 16KF24819, 16KF24820, 16KF24821, 16KF24822, 16KF24823, 16KF24824, 16KF24826, 16KF24827, 16KF24828, 16KF24830, 16KF24831, 16KF24832, 16KF24833, 16KF24834, 16KF24835, 16KF24836, 16KF24837, 16KF24838, 16KF24839, 16KF24842, 16KF24843, 16KF24845, 16KF24846, 16KF24847, 16KF24848, 16KF24849, 16KF24851, 16KF24852, 16KF24853, 16KF24854, 16KF24855, 16KF24856, 16KF24858, 16KF24859, 16KF24860, 16KF24861, 16KF24862, 16KF24863, 16KF24864, 16KF24867, 16KF24869, 16KF24870, 16KF24871, 16KF24872, 16KF24873, 16KF24874, 16KF24875, 16KF24877, 16KF24878, 16KF24879, 16KF24880, 16KF24881, 16KF24882, 16KF24883, 16KF24884, 16KF24887, 16KF24888, 16KF24889, 16KF24890, 16KF24891, 16KF24892, 16KF24893, 16KF24894, 16KF24895, 16KF24896, 16KF24897, 16KF24898, 16KF24899, 16KF24900, 16KF24901, 16KF24902, 16KF24903, 16KF24904, 16KF24905, 16KF24907, 16KF24908, 16KF24909, 16KF24910, 16KF24911, 16KF24912, 16KF24913, 16KF24914, 16KF24915, 16KF24917, 16KF24918, 16KF24919, 16KF24920, 16KF24922, 16KF24923, 16KF24924, 16KF24925, 16KF24927, 16KF24928, 16KF24929, 16KF24930, 16KF24931, 16KF24932, 16KF24933, 16KF24934, 16KF24935, 16KF24937, 16KF24938, 16KF24939, 16KF24941, 16KF24943, 16KF24946, 16KF24947, 16KF24948, 16KF24949, 16KF24950, 16KF24952, 16KF24955, 16KF24956, 16KF24957, 16KF24958, 16KF24961, 16KF24962, 16KF24963, 16KF24965, 16KF24966, 16KF24968, 16KF24970, 16KF24971, 16KF24972, 16KF24973, 16KF24975, 16KF24976, 16KF24977, 16KF24978, 16KF24979, 16KF24982, 16KF24984, 16KF24985, 16KF24986, 16KF24987, 16KF24988, 16KF24990, 16KF24991, and 16KF24992. MANUFACTURER: The American National Red Cross, Columbus, Ohio. RECALLED BY: Manufacturer, by letters dated August 18, 2000, and September 26, 2000. Firm initiated recall complete. DISTRIBUTION: OH, AZ, GA, MI, WI. QUANTITY: 195 units. REASON: Blood products, collected in bags that have loose or missing tabs that cover the sterile ports, were distributed. _______ PRODUCT: Red Blood Cells. Recall #B-1235-1. CODE: Unit numbers Y66981 and Y90479. MANUFACTURER: Aurora Area Blood Bank, Aurora, IL. RECALLED BY: Manufacturer, by letter dated February 13, 2001. Firm-initiated recall complete. DISTRIBUTION: IL. QUANTITY: Two units. REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. _______ PRODUCT: Red Blood Cells. Recall #B-1236-1. CODE: Unit number Y62399. MANUFACTURER: Aurora Area Blood Bank, Aurora, IL. RECALLED BY: Manufacturer, by letter dated February 8, 2001. Firm-initiated recall complete. DISTRIBUTION: IL. QUANTITY: 1 unit. Reason: Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. _______ PRODUCT: Red Blood Cells. Recall #B-1237-1. CODES: Unit numbers X53545, X64272, Y16818, and Y26136 MANUFACTURER: Aurora Area Blood Bank, Aurora, IL. RECALLED BY: Manufacturer, by letter dated October 10, 2000. Firm-initiated recall complete. DISTRIBUTION: IL. QUANTITY: 5 units. REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. _______ PRODUCT: a) Red Blood Cells. Recall #B-1238-1; b) Platelets. Recall #B-1239-1; c) Platelets Pheresis, Leukocytes Reduced. Recall #B-1240-1; d) Platelets Pheresis, Leukocytes Reduced Irradiated. Recall#B-1241-1. CODES: a) Unit number Y40608; b) Unit number Y40608; c) Unit numbers Y38062 and Y38088; d) Unit number Y38088. MANUFACTURER: Aurora Area Blood, Bank Aurora, IL. RECALLED BY: Manufacturer, by letter dated October 10, 2000. Firm initiated recall is complete. DISTRIBUTION: Illinois. QUANTITY: 4 units. REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. _______ PRODUCT: Red Blood Cells, Leukocytes Reduced. Recall #B-1242-1. CODES: Unit number 54KE13702. MANUFACTURER: The American National Red Cross, Rio Piedras, PR. RECALLED BY: Manufacturer, by telephone on December 7, 2000, and by letter dated December 13, 2000. Firm-initiated recall complete. DISTRIBUTION: PR. QUANTITY: 1 unit. REASON: Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. _______ PRODUCT: a) Red Blood Cells, Leukocytes Reduced. Recall #B-1243-1; b) Platelets, Leukocytes Reduced. Recall #B-1244-1. CODE: a) Unit number 33GT08673; b) Unit number 33GT08673. MANUFACTURER: The American National Red Cross Farmington, CT. RECALLED BY: Manufacturer, by letter dated February 7, 2001. Firm initiated recall complete. DISTRIBUTION: CT. QUANTITY: 2 units. REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. _______ PRODUCT: Fresh Frozen Plasma. Recall #B-1245-1. CODES: Unit LN91124. MANUFACTURER: New Brunswick Affiliated Hospitals Blood Center NBAH) New Brunswick, NJ. RECALLED BY: Manufacturer, by telephone on October 10, 2000. Firm initiated recall complete. DISTRIBUTION: N.J. QUANTITY: 1 unit. REASON: Blood product, collected from an unsuitable donor due to a donor screening question concerning behavior found to increase the risk of infection with human immunodeficiency virus (HIV), was distributed. ________ PRODUCT: Platelets Pheresis. Recall #B-1269-1. CODES: Unit number 28GP10257. MANUFACTURER: American Red Cross Blood Services Savannah, GA. RECALLED BY: Manufacturer, by telephone on July 23, 1998. Firm-intiated recall complete. DISTRIBUTION: SC. QUANTITY: 1 unit. REASON: Platelets with a decreased platelet count were distributed. ________ PRODUCT: a) Platelets Pheresis, Leukocytes Reduced. Recall #B-1270-1; b) Platelets Pheresis, Leukocytes Reduced Irradiated. Recall #B-1271-1. CODES: a) Unit numbers 8795595 and 8795598; b) Unit numbers 8795619 and 1415048. MANUFACTURER: New York Blood Center, Inc. ,310 East 67th Street, New York, NY. RECALLED BY: New York Blood Center, Inc., NY, by letter on June 7, 2000. Firm- initiated recall complete. DISTRIBUTION: NY. QUANTITY: 4 units. REASON: Platelets with a decreased platelet count were distributed. ________ PRODUCT: Red Blood Cells, Leukocytes Reduced. Recall #B-1273-1. CODES: Unit number 7860632. MANUFACTURER: LifeSource, Glenview, IL. RECALLED BY: Manufacturer by telephone on October 4, 2000. Firm-initiated recall complete. DISTRIBUTION: IL. QUANTITY: 1 unit. REASON: Blood product, manufactured using a filter that was subject to a recall due to leakage that could compromise the sterility of the blood product, was distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-1274-1; b) Platelets. Recall #B-1275-1; c) Fresh Frozen Plasma. Recall #B-1276-1; d) Plasma. Recall Recall #B-1277-1; e) Recovered Plasma. Recall #B-1278-1. CODE: a) Unit numbers 03GT43747, 03GT43732, 03GT43702, 03GT43703, 03GT43706 03GT43711, 03GT43715, 03GT43720, 03GT43723, 03GT43729, and 03GT43735; b) Unit numbers 03GT43747 and 03GT43715; c) Unit number 03GT43732; d) Unit number 03GT43735; e) Unit number 03GT43712. MANUFACTURER: The American National Red Cross, Atlanta, GA. RECALLED BY: Manufacturer, by telephone on July 12, 1999, and by letter dated July 26, 1999. Firm-initiated recall ongoing. DISTRIBUTION: GA, CA. QUANTITY: 16 units. REASON: Blood products, collected from donors where the venipuncture site had been inadequately prepared, were distributed. ________ PRODUCT: Red Blood Cells. Recall #B-918-1. CODES: Unit 2204006. MANUFACTURER: LifeShare, Inc.,Elyria, OH. RECALLED BY: Manufacturer, by letter dated November 28, 2000. Firm-initiated recall complete. DISTRIBUTION: OH. QUANTITY: 1 unit. REASON: Blood product, collected from a donor taking Actonel, was distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-919-1; b) Recovered Plasma. Recall #B-920-1. CODE: a)Unit 82508; b) Unit 82508. MANUFACTURER: Lane Memorial Blood Bank, Eugene, OR. RECALLED BY: Manufacturer, by letters dated November 9, 2000. Firm-initiated recall complete. DISTRIBUTION: OR and FL. QUANTITY: 2 units. REASON: Blood products, collected from a donor with a history of rheumatoid arthritis and fibromyalgia, were distributed.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT: Infant Umbilical Clamp with Security Transponder Device. Recall #Z-296-1. CODE: None. MANUFACTURER: Prosec Protection Systems, Inc., Lakewood, NJ. RECALLED BY: Manufacturer, by telephone on September 1, 2000. Firm-initiated recall complete. DISTRIBUTION: Nationwide. QUANTITY: 4395 clamps. REASON: Device sometimes slips off and may lead to infection (skin and bacteria) and blood loss. ________ PRODUCT: Midas Rex MRIV Motor System Catalog #MRIVMO. Recall #Z-515-1. CODES: 9500 to 9523, 96064-2, 962012, 2259. MANUFACTURER: Midas Rex, Fort Worth, TX. RECALLED BY: Manufacturer, by letter March 12, 2001. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide and Japan, Germany, Israel, Norway, and Switzerland. QUANTITY: 27 REASON: The motor overheats when operating within the active MRI field. ________ PRODUCT: Res-Q Micron Automated Implantable cardioverter. a) Model No. 101-05. Recall #Z-516-1. b) Model No. 101-09. Recall #Z-517-1. c) Model No. 101-10. Recall #Z-518-1. CODES: All serial numbers. MANUFACTURER: Sulzer Intermedics Inc., Angleton, TX. RECALLED BY: Guidant Corporation, Cardiac Rhythm Management, St. Paul, MN, by visit and letter dated March 23, 2001. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide, worldwide. QUANTITY: 2271. REASON: The unit indicates an improper end of service message and enters into backup mode disabling defibrillation therapy. ________ PRODUCT: a) Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left #9 35mm, Catalog No. 6088-0935-300L. Recall #Z-520-1. b) Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left #11 40mm, Catalog No. 6088-1140-300L. CODE: a) Lot No. S00L127; b) Lot No. S00L128. MANUFACTURER: Howmedica Osteonics Corporation, Allendale, N.J. RECALLED BY: Manufacturer, by letter dated February 16, 2001. Firm-initiated recall ongoing. DISTRIBUTION: Maryland. QUANTITY: 6 units -- 3 units of S00L127 and 3 units of S00L128. REASON: The Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left #9 35mm was labeled as the Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left # 11 40mm, and the Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left # 11 40mm was labeled as the Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left #9 35mm. ________ PRODUCT: Optetrak Total Knee Augmentation Blocks. Recall #Z-0554-1. CODE: Part Description Catalog Number 5mm Tibial Augmentation 1/3 Block Sz.1 204-41-05 8mm Tibial Augmentation 1/3 Block Sz.1 204-41-08 11mm RL, LM Tibial Augmentation 1/3 Block Sz.1 204-41-88 11mm RM, LL Tibial Augmentation 1/3 Block Sz.1 204-41-89 5mm Tibial Augmentation 1/3 Block Sz.2 204-42-05 8mm Tibial Augmentation 1/3 Block Sz.2 204-42-08 11mm RL, LM Tibial Augmentation 1/3 Block Sz.2 204-42-88 11mm LL, RM Tibial Augmentation 1/3 Block Sz.2 204-42-89 5mm Tibial Augmentation 1/3 Block Sz.3 204-43-05 8mm Tibial Augmentation 1/3 Block Sz.3 204-43-08 11mm RL, LM Tibial Augmentation 1/3 Block Sz.3 204-43-88 11mm LL, RM Tibial Augmentation 1/3 Block Sz.3 204-43-89 5mm Tibial Augmentation 1/3 Block Sz.4 204-44-05 8mm Tibial Augmentation 1/3 Block Sz.4 204-44-08 11mm RL, LM Tibial Augmentation 1/3 Block Sz.4 204-44-88 11mm RM, LL Tibial Augmentation 1/3 Block Sz.4 204-44-89 5mm Tibial Augmentation 1/3 Block Sz.5 204-45-05 8mm Tibial Augmentation 1/3 Block Sz.5 204-45-08 11mm RL, LM Tibial Augmentation 1/3 Block Sz.5 204-45-88 11mm RM, LL Tibial Augmentation 1/3 Block Sz.5 204-45-89 1/2 Tibial Augmentation Block, Sz 0 X 5 mm 204-60-05 1/2 Tibial Augmentation Block, Sz 0 X 8 mm 204-60-08 5mm Tibial Augmentation 1/2 Block Sz.1 204-61-05 8mm Tibial Augmentation 1/2 Block Sz.1 204-61-08 11mm RL, LM Tibial Augmentation 1/2 Block Sz.1 204-61-88 11mm RM, LL Tibial Augmentation 1/2 Block Sz.1 204-61-89 5mm Tibial Augmentation 1/2 Block Sz.2 204-62-05 8mm Tibial Augmentation 1/2 Block Sz.2 204-62-08 11mm RL, LM Tibial Augmentation 1/2 Block Sz.2 204-62-88 11mm RM, LL Tibial Augmentation 1/2 Block Sz.2 204-62-89 5mm Tibial Augmentation 1/2 Block Sz 3 204-63-05 8mm Tibial Augmentation 1/2 Block Sz 3 204-63-08 11mm RL, LM Tibial Augmentation 1/2 Block Sz 3 204-63-88 11mm RM, LL Tibial Augmentation 1/2 Block Sz 3 204-63-89 5mm Tibial Augmentation 1/2 Block Sz 4 204-64-05 8mm Tibial Augmentation 1/2 Block Sz 4 204-64-08 11mm RL, LM Tibial Augmentation 1/2 Block Sz 4 204-64-88 11mm RM, LL Tibial Augmentation 1/2 Block Sz 4 204-64-89 5mm Tibial Augmentation 1/2 Block Sz 5 204-65-05 8mm Tibial Augmentation 1/2 Block Sz 5 204-65-08 11mm RL, LM Tibial Augmentation 1/2 Block Sz 5 204-65-88 11mm RM, LL Tibial Augmentation 1/2 Block Sz 5 204-65-89 Full Wedge Tibial Augmentation, Size 1 X 07 deg 204-81-07 Full Wedge Tibial Augmentation, Size 2 X 07 deg 204-82-07 Full Wedge Tibial Augmentation, Size 3 X 20ƒ 204-82-13 Full Wedge Tibial Augmentation, Size 2 X 20 deg 204-82-20 Full Wedge Tibial Augmentation, Size 3 X 07 deg 204-83-07 Full Wedge Tibial Augmentation, Size 3 X 13 deg 204-83-13 Full Wedge Tibial Augmentation, Size 3 X 20 deg 204-83-20 Full Wedge Tibial Augmentation, Size 4 X 07 deg 204-84-07 Distal 5mm Femoral Aug, Sz. 1 208-05-01 Distal 5mm Femoral Aug, Sz. 2 208-05-02 Distal 5mm Femoral Aug, Sz. 3 208-05-03 Distal 5mm Femoral Aug, Sz. 4 208-05-04 Distal 5mm Femoral Aug, Sz. 5 208-05-05 Distal 10mm Femoral Aug. Sz. 1 208-06-01 Distal 10mm Femoral Aug, Sz. 2 208-06-02 Distal 10mm Femoral Aug, Sz. 3 208-06-03 Distal 10mm Femoral Aug, Sz. 4 208-06-04 Distal 10mm Femoral Aug, Sz. 5 208-06-05 Posterior 5mm Femoral Aug, Sz. 1 208-07-01 Posterior 5mm Femoral Aug, Sz. 2 208-07-02 Posterior 5mm Femoral Aug, Sz. 3 208-07-03 Posterior 5mm Femoral Aug, Sz. 4 208-07-04 Posterior 5mm Femoral Aug, Sz. 5 208-07-05 Posterior 10mm Femoral Aug, Sz. 1 208-08-01 Posterior 10mm Femoral Aug, Sz. 2 208-08-02 Posterior 10mm Femoral Aug, Sz. 3 208-08-03 Posterior 10mm Femoral Aug, Sz. 4 208-08-04 Posterior 10mm Femoral Aug, Sz. 5 208-08-05 5mm Tibial Augmentation 1/3 Block Sz.1 204-41-05 8mm Tibial Augmentation 1/3 Block Sz.1 204-41-08 11mm RL, LM Tibial Augmentation 1/3 Block Sz.1 204-41-88 11mm RM, LL Tibial Augmentation 1/3 Block Sz.1 204-41-89 5mm Tibial Augmentation 1/3 Block Sz.2 204-42-05 8mm Tibial Augmentation 1/3 Block Sz.2 204-42-08 11mm RL, LM Tibial Augmentation 1/3 Block Sz.2 204-42-88 11mm LL, RM Tibial Augmentation 1/3 Block Sz.2 204-42-89 5mm Tibial Augmentation 1/3 Block Sz.3 204-43- 8mm Tibial Augmentation 1/3 Block Sz.3 204-43-08 11mm RL, LM Tibial Augmentation 1/3 Block Sz.3 204-43-88 11mm LL, RM Tibial Augmentation 1/3 Block Sz.3 204-43-89 5mm Tibial Augmentation 1/3 Block Sz.4 204-44-05 8mm Tibial Augmentation 1/3 Block Sz.4 204-44-08 11mm RL, LM Tibial Augmentation 1/3 Block Sz.4 204-44-88 11mm RM, LL Tibial Augmentation 1/3 Block Sz.4 204-44-89 5mm Tibial Augmentation 1/3 Block Sz.5 204-45- 8mm Tibial Augmentation 1/3 Block Sz.5 204-45-08 11mm RL, LM Tibial Augmentation 1/3 Block Sz.5 204-45-88 11mm RM, LL Tibial Augmentation 1/3 Block Sz.5 204-45-89 1/2 Tibial Augmentation Block, Sz 0 X 5 mm 204-60-05 1/2 Tibial Augmentation Block, Sz 0 X 8 mm 204-60-08 5mm Tibial Augmentation 1/2 Block Sz.1 204-61-05 8mm Tibial Augmentation 1/2 Block Sz.1 204-61-08 11mm RL, LM Tibial Augmentation 1/2 Block Sz.1 204-61-88 11mm RM, LL Tibial Augmentation 1/2 Block Sz.1 204-61-89 5mm Tibial Augmentation 1/2 Block Sz.2 204-62-05 8mm Tibial Augmentation 1/2 Block Sz.2 204-62-08 11mm RL, LM Tibial Augmentation 1/2 Block Sz.2 204-62-88 11mm RM, LL Tibial Augmentation 1/2 Block Sz.2 204-62-89 5mm Tibial Augmentation 1/2 Block Sz 3 204-63-05 8mm Tibial Augmentation 1/2 Block Sz 3 204-63-08 11mm RL, LM Tibial Augmentation 1/2 Block Sz 3 204-63-88 11mm RM, LL Tibial Augmentation 1/2 Block Sz 3 204-63-89 5mm Tibial Augmentation 1/2 Block Sz 4 204-64-05 8mm Tibial Augmentation 1/2 Block Sz 4 204-64-08 11mm RL, LM Tibial Augmentation 1/2 Block Sz 4 204-64-88 11mm RM, LL Tibial Augmentation 1/2 Block Sz 4 204-64-89 5mm Tibial Augmentation 1/2 Block Sz 5 204-65-05 8mm Tibial Augmentation 1/2 Block Sz 5 204-65-08 11mm RL, LM Tibial Augmentation 1/2 Block Sz 5 204-65-88 11mm RM, LL Tibial Augmentation 1/2 Block Sz 5 204-65-89 Full Wedge Tibial Augmentation, Size 1 X 07 deg 204-81-07 Full Wedge Tibial Augmentation, Size 2 X 07 deg 204-82-07 Full Wedge Tibial Augmentation, Size 3 X 20ƒ 204-82-13 Full Wedge Tibial Augmentation, Size 2 X 20 deg 204-82-20 Full Wedge Tibial Augmentation, Size 3 X 07 deg 204-83-07 Full Wedge Tibial Augmentation, Size 3 X 13 deg 204-83-13 Full Wedge Tibial Augmentation, Size 3 X 20 deg 204-83-20 Full Wedge Tibial Augmentation, Size 4 X 07 deg 204-84-07 Distal 5mm Femoral Aug, Sz. 1 208-05-01 Distal 5mm Femoral Aug, Sz. 2 208-05-02 Distal 5mm Femoral Aug, Sz. 3 208-05-03 Distal 5mm Femoral Aug, Sz. 4 208-05-04 Distal 5mm Femoral Aug, Sz. 5 208-05-05 Distal 10mm Femoral Aug. Sz. 1 208-06-01 Distal 10mm Femoral Aug, Sz. 2 208-06-02 Distal 10mm Femoral Aug, Sz. 3 208-06-03 Distal 10mm Femoral Aug, Sz. 4 208-06-04 Distal 10mm Femoral Aug, Sz. 5 208-06-05 Posterior 5mm Femoral Aug, Sz. 1 208-07-01 Posterior 5mm Femoral Aug, Sz. 2 208-07-02 Posterior 5mm Femoral Aug, Sz. 3 208-07-03 Posterior 5mm Femoral Aug, Sz. 4 208-07-04 Posterior 5mm Femoral Aug, Sz. 5 208-07-05 Posterior 10mm Femoral Aug, Sz. 1 208-08-01 Posterior 10mm Femoral Aug, Sz. 2 208-08-02 Posterior 10mm Femoral Aug, Sz. 3 208-08-03 Posterior 10mm Femoral Aug, Sz. 4 208-08-04 Posterior 10mm Femoral Aug, Sz. 5 208-08-05. MANUFACTURER: EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL. RECALLED BY: Manufacturer, by telephone beginning on March 21, 2001 and by letter dated April 12, 2001. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 1440. REASON: Sterility barrier failure ________ PRODUCT: OncoSeed Iodine-125 Seeds; a welded titanium capsule containing Iodine- 125 adsorbed onto a silver rod; Medi-Physics, Inc., Arlington Heights, IL 60004 U.S.A. Recall #Z-0555-1. CODE: 6711 MANUFACTURER: Medi-Physics, Inc. dba Nycomed Amersham Imaging, Arlington Heights, IL. RECALLED BY: The manufacturer, by telephone on 4/6/01, on 4/10/01 and again on 4/11/01. Firm-initiated recall ongoing. DISTRIBUTION: Ottawa Regional Cancer Centre, Ottawa, Canada. QUANTITY: 165 seeds. REASON: Seeds have a higher radioactivity than stated on the label ________ PRODUCT: Efica CC (Dynamic Air Therapy Unit). Recall #Z-560-1. CODE: Serial Numbers *LA700023-LA708141 (*not all inclusive) Manufactured 7/94 - 5/98 MANUFACTURER: Hill-Rom, Inc., Charleston, SC. RECALLED BY: Manufacturer, by letter on 10/6/00. Further modification by field service in April, 2001. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide and to Brazil, Egypt, Japan, Malaysia, Mexico, Poland, Taiwan and United Arabia Emerance. There was also government distribution. QUANTITY: 2450 units REASON: Device batteries were alleged to have given off a strong odor. ________ PRODUCT: a) NexGen Knee Threaded Fixation Pin. Recall #Z-558-1; b) NexGen Knee Threaded Fixation Pin. Recall #Z-559-1. CODE: a) Lot No. 71350300, Catalog No. 00-5978-013-00; b) Lot No. 71915000, Catalog No. 00-5978-013-00. MANUFACTURER: Zimmer, Inc., Warsaw, IN. RECALLED BY: Manufacturer, by letter on April 2, 2001. Firm-initiated recall ongoing. DISTRIBUTION: United States, Australia, Belgium, Canada Germany, Italy, Japan and the United Kingdom. QUANTITY: 708 REASON: The hex end of the pin will not assemble with the driver to secure the Micro-Mill femoral mounting base instrumentation to the surgical site. ________ PRODUCT: Thermo Labsystemís DSX Automated System. a) Recall #Z-561-1; b) Recall #Z-562-1; c) Recall #Z-563-1; d) Recall #Z-564-1; e) Recall #Z-565-1; f) Recall #Z-566-1; g) Recall #Z-567-1. CODE: a) Model No. 61500; b) Model No. 65200; c) Model No. 65210; d) Model No. 65300; e) Model No. 65400; f) Model No. 65410; and g) Model No. 65500. MANUFACTURER: DYNEX TECHNOLOGIES (THERMO LABSYSTEMS), Chantilly, VA. RECALLED BY: Manufacturer, by letter on 4/18/2001. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide, and Spain, Hong Kong, United Kingdom, Australia, Korea, and Italy. QUANTITY: 73. REASON: Incorrect sample volume may be dispensed and therefore produce erroneous test results. In addition, an Electro Magnetic incompatibility in the instrument may cause instrument to report an error and lock-up. ________ PRODUCT: MedComp 14F Ash Split Cath Long Term, Duo-Flow 400XL, and Duo-Split Cath Short Term Hemodialysi or Apheresis Catheters. Recall #Z-0549-1. CODE: Catalog Numbers: ASPC24 (14F x 24 cm Ash Split Cath), ASPC28 (14F x 28cm Ash Split Cath), ASPC28I (14F x 28cm Ash Split w/Introducer), ASPC32 (14F x 32cm Ash Split Cath Set), ASPC32I (14F x 32cm Ash Split w/Introducer), ASPC32MP (14F x 32cm Ash Split w/MP4), ASPC36 (14F x 36 cm Ash Split Cath Set), ASPC55 (14F x 558cm Ash Split Cath), DFXL146CT (14F x 15cm Duo-Flow 400XL Cath), DFXL146MTB (14F x 15cm Duo-Flow 400XL Cath), DFXL146IJS (14F x 15cm Duo-Flow 400XL IJ), DFXL148 (14F x 20cm Duo-Flow XL Tray), DFXL148CT (14F x 20cm Duo-Flow 400XL Cath), DXFL148MT (14F x 20cm Duo-Flow 400XL Set), DXFL148MTB (14F x 20cm Duo-Flow 400XL Set), DFXL149CT (14F x 24cm Duo-Flow 400XL Cath), DSP128M (12.5F x 20cm Duo-Split), Tray #552 (14F x 28cm Ash Split Cath), Tray #553 (14F x 32 cm Ash Split Cath), and Tray #594 (14F x 36cm Ash Split Cath Set). MANUFACTURER: MEDICAL COMPONENTS, INC., Harleysville, PA. RECALLED BY: Manufacturer, by fax on September 22, 2000. Firm-initiated recall complete. DISTRIBUTION: Canada and South Korea. The following are government/military accounts: CALM VA in Dallas and Houston, TX; Defense Fin, San Antonio, TX; DFAS, Fort Sam Houston, TX; Fort Atkinson Memorial, Fort Atkinson, WI; VA, Miami, Fl; NNMC, Bethesda, Md; Naval Med Ctr, Portsmouth, VA; Naval Med Ctr, San Diego, CA; and the VA Hospitals in San Juan, PR; Austin, TX; Philadelphia, PA; Cincinnati, OH; Indianapolis, IN; Minneapolis, MN; Asheville, NC; Loma Linda, CA; Los Angeles, CA; San Diego, CA; Long Beach, CA; Salem, VA; Iowa City, IA; St. Louis, MO; Tampa, Fl; Durham, NC; West Haven, CT; and Gainesville, FL. QUANTITY: 5930 units. REASON: Pinch/line clamp not fully occluding tubing when engaged.RECALLS AND FIELD CORRECTIONS: VETMED -- CLASS II
RECALL NO.ID NO.PRODUCT V-033-1 1186 OMOLENE #300 V-034-1 4987 PURINA HORSE PELLET 14 V-035-1 27690 CATTLE COMPLETE #4 V-036-1 10602 HORSEMAN'S EDGE 12 COARSE V-037-1 5541 GRAIN LND CRS CRKD CRM V-038-1 1194 HORSE CHOW #100 V-039-1 27313 SHOWCHOW LEAN 50 L160 V-040-1 1199 HORSE CHARGE V-041-1 6214 CALF STARTER (COARSE) OTC 6 V-042-1 1384 GAME FLIGHT CONDÖÖ-- V-043-1 14971 PREPARE COMP II 18% V-044-1 28493 CU BRND A/L PLT PK V-045-1 1381 GAME BIRD STARTENA W/O ETTS V-046-1 27459 LN GN ST S2 CPSTZ V-047-1 7375 SHOW CHOW PREMIUM DEV DTC 7 V-048-1 28394 CU 1 CATTLE HOLDING V-049-1 28383 RANGE CAKE 20.SM CKR V-050-1 1505 START & GROW W/O ETTS V-051-1 39335 ACCURATION CTL DEV- V-052-1 28515 CU CAKE CUBE N V-053-1 38056 COMM CATTLE ST CTC140 V-054-1 37883 RANGE CAKE 20N 5/32 V-055-1 36668 CATTLE GROWER 32 RM 175 V-056-1 28450 WILD TURKEY CON MP.025% V-057-1 28443 PURINA ELK CHECKERS 20% V-058-1 28452 BB SCRATCH GRAIN V-059-1 39356 ACCURATION CTL COND. V-060-1 39747 NATURAL BEEF BUILDER COARSE V-061-1 26753 HORSEMAN'S EDGE PELLET 14% V-062-1 1506 START & GROW MP 0.0125% 50# V-063-1 1386 GAMEBIRD BRDR LAYENa ETTS V-064-1 27917 SWEET GRAIN MIX 9 V-065-1 19283 COMM CATTLE ST CTSM V-066-1 27310 SHWCHPIG G17-XL L160 V-067-1 18346 COMP SOW OVAL V-068-1 28255 HOG FINISHER LND W/O V-069-1 27140 CALF GROWENA 16% BVT 60 V-070-1 27460 SH CH PIG ST20-XL L140 V-071-1 28103 MAZ OSTRICH BREEDER V-072-1 5540 GRAIN LAND WHOLE CORN V-073-1 1195 HORSE CHOW #200 V-074-1 28340 LAMB SHOW RATION CTC50 V-075-1 43289 OMOLENE #300 GROWTH V-076-1 28387 FORAGE BALANCER 20N 3/8 V-077-1 43771 HFC SHOW PIG 20% T 100 V-078-1 28863 CS ACU-MN VEG PS#1, 2 RM300 V-079-1 28555 CU STANDRIDGE GRW RM700 V-080-1 43660 HF&C SHOW CHOW PIG STR W/O V-081-1 38255 PHEASANT FLIGHT COND HM BMD50 V-082-1 37504 COMM TX CATTLE STR CTSM 77.7 V-083-1 28451 BB WHOLE MILO V-084-1 28448 WILD TU COND. MP-BMD V-085-1 28441 HI-PRO DEER CHECKERS V-086-1 43661 HF&C SHOW CHOW PIG STR T100 V-087-1 39357 HI-ENERGY BEEF CKR V-088-1 40849 NATURAL BEEF BREEDER V-089-1 16647 PHEAS FLIGHT COND BMD 50 V-090-1 1822 EQUINE ADULT V-091-1 16645 PHEASANT FLIGHT COND W/O V-092-1 11040 ACCU CONCENTRATE V-093-1 9798 CATTLE FINISHER 40 W/O.. V-094-1 23778 ACCU - CREEP V-095-1 19353 CATTLE FIN 40 RM1200 V-096-1 19293 LAMB SHOW GRO/FIN CRS V-097-1 26720 SW DROUGHT CUBE V-098-1 6912 PURINA ELK CHECKERS 20% 5/32 V-099-1 24566 FOR BAL ML4 1:3 CTC70 V-100-1 28310 SOUTHWEST 14N BVT 80 V-101-1 28304 SOUTHWEST 12N HI - F V-102-1 28296 SOUTHWEST 14 N CTC28 V-103-1 44627 SHOW CH PIG ST/GR L1 200 V-104-1 28332 SOUTHWEST 12N RM 25 V-105-1 27357 FORAGE BALANCER 20M 3/4 V-106-1 28292 SOUTHWEST 14N 3/8" V-107-1 28291 SOUTHWEST 14N 1/4" V-108-1 25035 STABLE STAR SWEET 12 V-109-1 9803 RABBIT COMP BLEND 50 % V-110-1 27923 STABLE STAR SWEET GRAIN 9 V-111-1 5639 LAYENA CRUMBLES LG ETT V-112-1 1185 OMOLENE #200 V-113-1 1209 EQUINE SENIOR V-114-1 27354 RANGE CAKE 20 3/4 V-115-1 9732 SHOW CHOW PREMIUM GLD FN CTC7 V-116-1 28293 SW 14N 3/4" W/O V-117-1 27312 LEAN GEN 110 L140 V-118-1 4701 PRE - COND - REC CHOW DO .0025% V-119-1 28021 FEEDLOT 40 W/O MEAL V-120-1 11415 WHOLE CORN V-121-1 16283 ACCU CONCENTRATE RM150 V-122-1 19383 ACCU - CHICKEN BLEND GSÖ V-123-1 17632 STOCKYARDS CHOW V-124-1 24544 FORAGE BAL ML 4 1:3 V-125-1 25064 MAZ OSTRICH GR/MAINT V-126-1 24745 WILD TU STARTER MP - BMD V-127-1 28106 HI - PRO DEER CHRS - WC V-128-1 28308 SOUTHWEST 38N V-129-1 28299 BB STEER RATION V-130-1 28311 SOUTHWEST 38N RM 200 V-131-1 28338 SOUTHWEST 14N BVT 60 V-132-1 27352 RANGE CAKE 20N 3/4 V-133-1 4998 STRATEGY - GX V-134-1 1102 PRECONDITION/RECEIVING CTSM 1/4 V-135-1 28405 STABLE STAR SWEET GRAIN 14 V-136-1 1206 EQUINE JUNIOR V-137-1 28348 CATTLE COMPLETE #3ÖÖ V-138-1 1184 OMOLENE #100 V-139-1 5628 LAYENA PELLETS V-140-1 28376 RANGE CAKE 20N 3/8" V-141-1 388 COMPLETE SOW III W/O V-142-1 5887 SHOW CHOW LAMB G/F CRSE CTC50 V-143-1 10603 HORSEMAN'S EDGE 14% COARSE V-144-1 1403 GOAT CHOW V-145-1 1560 SCRATCH GRAINS V-146-1 19319 HORSE & MULE V-147-1 28245 HOG GROWER OTC50 V-148-1 28321 SOUTHWEST 14N DO.0037% V-149-1 28236 LN GN STR S1 CPSTZ - 250 V-150-1 28207 PREP PLUS COMP HL 18 V-151-1 28240 SHOW CHOW PIG ST.20-XL V-152-1 28290 SOUTHWEST 14N 5/32" V-153-1 1480 MAZURI EMU STARTER V-154-1 1189 PURE PRIDE #200 V-155-1 1508 MEATBUILDER MP 0.0125% V-156-1 27921 SWEET GRAIN MIX 12 V-157-1 26671 GOLDEN MILK B16 V-158-1 28397 B.B. HORSE & MULE V-159-1 28456 BB WHOLE OATS V-160-1 1371 ADV- NUT PROF FORM RABBIT V-161-1 40996 MAZURI PRIMATE MAINTENANCE BISCUIT V-162-1 43288 OMOLENE #200 PERFORMANCE V-163-1 28601 HORSEMAN'S EDGE 14% V-164-1 28612 BEEF PROMIX#100 CTSM V-165-1 28419 SOUTHWEST 12N RM 150 V-166-1 28371 GRASS STR 16 NÖÖÖ. V-167-1 28361 CTL LIM RTN #4 RM110 V-168-1 28360 CTLE LIM RTN #3 RM70 V-169-1 27326 PUR-LYX 21 V-170-1 672 HOG CHOW 40 MEAL V-171-1 28287 COMM CATTLE ST W/O V-172-1 28322 CS SW 14 N, TRM V-173-1 28239 MEAL V-174-1 28235 PIG STARTENA - 61900 V-175-1 1488 MAZ EMU MAINTENANCE V-176-1 1165 ACCURATION 2 HL MEAL V-177-1 1461 GRAIN LAND WHOLE OATS V-178-1 28241 SHOW CHOW PIG GROW-17-XL V-179-1 1493 PURINA OSTRIGRO COMPLETE V-180-1 28246 PIG STARTENA CP-STZ V-181-1 1190 PURE PRIDE #300 V-182-1 26957 CTLE LIM RAT #1 RM40 V-183-1 26860 COM CALF S/G CRS BVT60 V-184-1 27325 COMM CATTLE ST DO V-185-1 12837 CATTLE FINISHER 50 W/O.. V-186-1 43287 OMOLENE #100 PLEASURE V-187-1 43770 HFC SHOW PIG 20% V-188-1 28615 SOUTHWEST 12N V-189-1 28616 SOUTHWEST 12N V-190-1 28408 BEEF PRO MIX 50 V-191-1 28363 CTLE LIM TRN #5 RM180 V-192-1 43337 HF&C SHOW CHOW PIG STR CDX 50 V-193-1 28372 FRG BAL ML4 1:3 CTC750 CODE: 70YY-99, 69YY-99. MANUFACTURER: Purina Mills, Oklahoma City, OK 73106. RECALLED BY: The manufacturer initiated the recall by letter dated 2/16/01 flagged "URGENT RECALL" to all direct accounts. Firm-initiated recall ongoing. DISTRIBUTION: OK, AR, KA. QUANTITY: 161 Units. REASON: The products have missing or incomplete labeling; items lacking include statement of ingredients, lot number, place of manufacture, percent fat & protein, etc. Most products are bagged into bags with a pre-printed unique product name, less than 5% are not.END OF ENFORCEMENT REPORT FOR MAY 23, 2001. ####
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