October 24, 2001 01-42
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-026-2, Bamboo Shoots in flexible plastic bags, net wt. 14 oz. (400 g). Product of China. Codes: Barcode # 6 915531 280224 and no other coding. REASON: The product contained undeclared sulfites. MANUFACTURER/RECALLING FIRM: Yeung Kong Food Co., Ping Shan, N.T. Hong Kong RECALLED BY: Advance Imports Inc. Brooklyn, NY, by letter, telephone and visit on 11/14/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: Flushing, NY QUANTITY: 34 cases (20 -14 oz. bags per case) were distributed.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-019-2, Royale Dark Chocolate Covered Peppermint Patties F-020-2, Royale Dark Chocolate Coconut Patties F-021-2, Royale Dark Chocolate Vanilla Cremes F-022-2, Royale Dark Chocolate Dipped Fruit Cremes (Tropical Pina Colada) F-023-2, Royale Dark Chocolate Dipped Fruit Cremes (Tropical Key Lime) F-024-2, Royale Dark Chocolate Dipped Fruit Cremes (Tropical Mango) F-025-2, Eddyleon Jelly Graham Cookies Codes: Lot 1 474 08-00. This lot number is for the box only since the recalling firm does not use lot or batch numbers. REASON: The products contain undeclared milk residue. MANUFACTURER/RECALLING FIRM: Eddyleon Chocolate Company Moosic, PA RECALLED BY: The recalling firm by letter dated 9/10/01 FIRM INITIATED RECALL: Complete DISTRIBUTION: CT, FL, GA, MI, NY, and PA. QUANTITY: 45,108 boxesRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1779-1, Corneas, Units C-01-109-OS, C-01-109-OD REASON: Corneas, collected from a donor who tested repeat reactive for HIV 1/2, and was confirmed positive by Western Blot, were distributed. MANUFACTURER/RECALLING FIRM: Lions Eye and Tissue Bank, Inc., Seabrook, MD RECALLED BY: The recalling firm by telephone on February 8, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: MO QUANTITY: 1 unitRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
* Correction to Recall B-1301-1, reported in the ER of June 20, 2001. The "Reason" is corrected to read as follows: “Corneas, that were collected from a donor who tested repeatedly reactive for the antibody to the Hepatitis B core antigen (anti-HBc), and non reactive for hepatitis B core IgM, were distributed.” _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1915-1, Platelets, Unit 24GJ44021 REASON: Blood product, collected from a donor who had taken Feldene, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Louisville, KY RECALLED BY: Recalling firm, by letter dated May 22, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IN QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1977-1, Platelets, Unit 1486289 REASON: Blood product, collected from a donor who had body piercing within twelve months of donation, was distributed. MANUFACTURER/RECALLING FIRM: New York Blood Center (Center West), New York, NY RECALLED BY: Recalling firm by letter dated May 25, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: NY QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0003-2, Recovered Plasma, Unit 21GW22390 REASON: Blood products, collected from a donor with a history of hepatitis, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross, Portland, OR RECALLED BY: Recalling firm by letter on December 15, 2000 FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0004-2, Red Blood Cells, Units BB150871 B-0005-2, Red Blood Cells, Leukoreduced, Unit 4160632 B-0006-2, Platelets, Unit 4160632 REASON: Blood products, collected from a donor with a history of hepatitis, were distributed. MANUFACTURER/RECALLING FIRM: Blood Bank of Alaska, Anchorage, AK RECALLED BY: Recalling firm by letter dated March 29, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: AK QUANTITY: 3 units ______________________________ RECALL NUMBER,PRODUCT AND CODE: B-0007-2, Red Blood Cells Units 20E22322, 20J19751, 20J33942, 20W05141 B-0008-2, Fresh Frozen Plasma, Unit 20W05141 B-0009-2, Recovered Plasma, Units 20E22322, 20J19751, 20J33942 REASON: Blood products, collected from a donor with a history of having tested positive for HCV, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Salt Lake City, Utah RECALLED BY: American Red Cross Blood Services, Boise, ID, by telephone on August 28, 2000 and by letter dated August 29, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA and UT QUANTITY: 8 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0011-2, Red Blood Cells, Units 21GW24159, 21GW21039 B-0012-2, Recovered Plasma, Units 21GW24159, 21GW21039 REASON: Blood products, collected from a donor with a history of jaundice, were distributed. MANUFACTURER/RECALLING FIRM: American National Red Cross, Portland, OR RECALLED BY: The recalling firm by letter dated December 12, 2000 and December 20, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA and OR QUANTITY: 4 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0015-2, Source Plasma for Manufacturing Use Only, Unit 76187308 REASON: Blood product, which tested repeat reactive for anti-HCV, was distributed. MANUFACTURER/RECALLING FIRM: Interstate Blood Bank, Inc., Milwaukee, WI RECALLED BY: Interstate Blood Bank, Inc., Memphis, TN, by telephone and fax on April 7, 1997 FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0018-2, Red Blood Cells, Leukoreduced, Irradiated, Unit 33GE30491 B-0019-2, Platelets, Leukoreduced, Unit 33GE30491 B-0020-2, Recovered Plasma, Frozen, Unit 33GE30491 REASON: Blood products, which tested negative for the antibody to the human immunodeficiency virus type 1 (HIV-1), but were collected from a donor who previously tested repeatedly reactive for the antibody, with a negative confirmatory test, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross, Farmington, CT RECALLED BY: The recalling firm by letter dated April 20, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: CT and CA QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0021-2, Source Plasma, Units 38700088, 38697456, 38688492, 38686153, 38681226, 38678806, 38673689, 38671548, 38666735, 38664281 REASON: Blood products, collected from a donor who had a tattoo within twelve months of donation, were distributed. MANUFACTURER/RECALLING FIRM: Nabi BioMedical Center, Corpus Christi, Texas RECALLED BY: The recalling firm by fax dated October 18, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 10 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0022-1, Red Blood Cells, Unit 0669878 REASON: Blood product, which was stored at unacceptable temperatures, was distributed. MANUFACTURER/RECALLING FIRM: Memorial Blood Center, Minneapolis, MN RECALLED BY: The recalling firm by telephone on or about August 6, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: MN QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0029-2, Red Blood Cells, Unit 21G96538 B-0030-2, Platelets, Unit 21G96538 REASON: Blood products, which tested reactive for anti-HCV, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross, Portland, OR RECALLED BY: The recalling firm by letter dated October 19, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: WA and OR QUANTITY: 2 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0031-2, Red Blood Cells, Unit 2012772 B-0032-2, Platelets, Unit 2012772 B-0033-2, Recovered Plasma, Unit 2012772 REASON: Blood products, collected from a donor with a history of having tested positive for HCV, were distributed. MANUFACTURER/RECALLING FIRM: The Community Blood Center, Inc., Appleton, Wisconsin RECALLED BY: The recalling firm by letter dated March 28, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: WI and FL QUANTITY: 3 units ______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0034-2, Red Blood Cells, Unit 20J15089 B-0035-2, Platelets, Unit 20J15089 B-0036-2, Fresh Frozen Plasma, Unit 20J15089 REASON: Blood products, collected from a donor with a history of testing positive for hepatitis C, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Salt Lake City, UT RECALLED BY: American Red Cross, Boise, ID, by letter dated March 16, 2000 FIRM INITIATED RECALL: Complete DISTRIBUTION: CA and UT QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0040-2, Source Plasma, Unit number YP26790 REASON: Blood product, collected from a donor that subsequently tested repeatedly reactive for the antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), was not properly quarantined and was distributed. MANUFACTURER/RECALLING FIRM: Interstate Blood Bank, Inc., Milwaukee, WI RECALLED BY: Interstate Blood Bank, Inc., Memphis, TN, by telephone on February 3, 1997 FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0041-2, Red Blood Cells, Leukocytes Reduced, unit numbers 40GJ36723, 40GF41207, and 40GC58691 REASON: Blood products, that tested positive for the Jkb antigen, but were labeled Jkb antigen negative, were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Peoria, IL RECALLED BY: The recalling firm by telephone on July 16, 2001, and by letter dated August 7, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0042-2, Platelets, unit number 13FC15728 B-0043-2, Fresh Frozen Plasma, unit number 13FC15728 REASON: Blood products, corresponding to a unit of Red Blood Cells that was possibly contaminated with coagulase negative Staphylococcus sp. bacteria, were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Detroit, MI RECALLED BY: The recalling firm by telephone on February 27, 2001, and by letter dated March 2, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: MI QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0044-2, Red Blood Cells, unit number 0733009 REASON: Blood product, manufactured in a manner that may have compromised the sterility of the unit, was distributed. MANUFACTURER/RECALLING FIRM: Memorial Blood Centers of Minnesota, Minneapolis, MN RECALLED BY: The recalling firm by telephne on October 13, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MN QUANTITY: 1 unit RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-889-1, Source Plasma, unit numbers 1941V045A and 1941V140A REASON: Blood products, collected from an ineligible donor due to a history of the disease Lupus, were distributed. MANUFACTURER/RECALLING FIRM: Aventis Bio-Services, Inc., Fort Worth, TX RECALLED BY: The recalling firm by letter on April 6, 1999 FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1789-1, Red Blood Cells, Leukoreduced, Units 49W35857, 49W35858, 49W35859 REASON: Blood products, collected in expired blood collection bags, were distributed. MANUFACTURER/RECALLING FIRM: American National Red Cross, Tulsa, OK RECALLED BY: The recalling firm by telephone on March 30, 2001 and by letters dated April 11, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: TX and OK QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0016-2, Red Blood Cells, Leukoreduced, Unit 53FP37527 B-0017-2, Platelets, Unit 53FP37527 REASON: Blood products, which were not quarantined after receiving information concerning a post donation illness, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Baltimore, Maryland RECALLED BY: The recalling firm by telephone or by letter on May 30, 2001 or June 11, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: MD and DC QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0023-2, Source Plasma for manufacturing use only Units 99SWIA0082 99SWIA0503 99SWIA0592 99SWIA0717 99SWIA9566 99SWIA1029 99SWIA1035 99SWIA1998 99SWIA2401 99SWIA9686 99SWIA2920 99SWIA3032 99SWIA3415 99SWIA4095 99SWIA9693 99SWIA4096 99SWIA4182 99SWIA4283 99SWIA4290 99SWIA9855 99SWIA4361 99SWIA4902 99SWIA5134 99SWIA5236 99SWIA5481 99SWIA5307 99SWIA5884 99SWIA6306 99SWIA6500 99SWIA6449 99SWIA6674 99SWIA7580 99SWIA8031 99SWIA8218 99SWIA8325 99SWIA8372 99SWIA8389 99SWIA8630 99SWIA8702 99SWIA8748 99SWIA8884 99SWIA8919 99SWIA8931 99SWIA5672 99SWIA5695 99SWIB0345 99SWIB0438 99SWIB0503 99SWIB0525 99SWIB0799 99SWIB1237 99SWIB1338 99SWIB1351 99SWIB1441 99SWIB1505 99SWIB1590 99SWIB1697 99SWIB1802 99SWIB1823 99SWIB1850 99SWIB1860 99SWIB1886 99SWIB1960 99SWIB2115 99SWIB2252 99SWIB2364 99SWIB2380 99SWIB2558 99SWIB2813 99SWIB2850 99SWIB3011 99SWIB3049 99SWIB3486 99SWIB3503 99SWIB3548 99SWIB3860 99SWIB4049 99SWIB4133 99SWIB4706 99SWIB4734 99SWIB4845 99SWIB5100 99SWIB5483 99SWIB5721 99SWIB5774 99SWIB5976 99SWIB6282 99SWIB6506 99SWIB6533 99SWIB6853 99SWIB6875 99SWIB7433 99SWIB7460 99SWIB7487 99SWIB7928 99SWIB7978 99SWIB8333 99SWIB8434 99SWIB9033 99SWIC0170 REASON: Blood products, collected from a donor whose health screening was not adequately performed, were distributed MANUFACTURER/RECALLING FIRM: Community Bio-Resources, Inc., Sheboygan, WI RECALLED BY: Community Bio-Resources, Inc., Hoover, AL by fax on December 9, 1999 FIRM INITIATED RECALL: Complete DISTRIBUTION: MI and Australia QUANTITY: 100 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0024-2, Source Plasma for Manufacturing Units 98LWIA5125 98LWIA6216 98LWIA7000 98LWIA7030 98LWIA7122 98LWIA8207 98LWIA8527 98LWIA8585 98LWIA8588 98LWIA9513 99LWIA0107 99LWIA0773 99LWIA1642 99LWIA1648 99LWIA2805 99LWIA2834 99LWIA2850 99LWIA3531 99LWIA4661 99LWIA6061 99LWIA6433 99LWIA6705 99LWIA6801 99LWIA6938 99LWIA8336 99LWIA9173 98LWIB0255 98LWIB0496 98LWIB0508 98LWIB0579 98LWIB0595 98LWIB0650 98LWIB1209 98LWIB1661 98LWIB1820 98LWIB1841 98LWIB1875 98LWIB2893 98LWIB2931 98LWIB3285 98LWIB3297 98LWIB3301 98LWIB3321 98LWIB3322 98LWIB3605 98LWIB3659 98LWIB3806 98LWIB4110 98LWIB4316 98LWIB4340 99LWIB0513 99LWIB0906 99LWIB1085 99LWIB1167 99LWIB1393 99LWIB2117 98LWIB2382 99LWIB2548 99LWIB4701 99LWIB4707 99LWIB4764 99LWIB5551 99LWIB5555 99LWIB5564 99LWIB5567 99LWIB5952 99LWIB5984 99LWIB6113 99LWIB6117 99LWIB6123 99LWIB6174 99LWIB6184 99LWIB6114 99LWIB6512 99LWIB6517 99LWIB6552 99LWIB6568 99LWIB6584 99LWIB6706 99LWIB6711 99LWIB6733 99LWIB6762 99LWIB6765 99LWIB6981 99LWIB7029 99LWIB7802 99LWIB8194 99LWIB8204 99LWIB8542 99LWIB8545 99LWIB8667 99LWIB9749 99LWIC1005 99LWIC1063 99LWIC3340 99LWIC4553 99LWIC5567 99LWIC5614 99LWIC5624 99LWIC6987 99LWIC8702 99LWIC8737 99LWIC8753 99LWID0341 99LWID1981 99LWID2701 99LWID3765 99LWID4205 99LWID5538 99LWID5627 99LWID6173 99LWID6454 99LWID7345 99LWID7446 99LWIC8738 REASON: Blood products, collected from a donor whose health screening was not adequately performed, were distributed MANUFACTURER/RECALLING FIRM: Community Bio-Resources, Inc., Onalaska, WI RECALLED BY: Community Bio-Resources, Inc., Hoover, AL, by fax on December 9, 1999 FIRM INITIATED RECALL: Complete DISTRIBUTION: MI and Austria QUANTITY: 115 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0025-2, Source Plasma for Manufacturing Use Only, Unit 00MMNC4820 REASON: Blood product, collected under conditions where the sterility may have been compromised, was distributed. MANUFACTURER/RECALLING FIRM: Community Bio-Resources, Inc., Mankato, MN RECALLED BY: Community Bio-Resources, Inc., Hoover, AL, by fax dated August 8, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: Austria QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0026-2, Red Blood Cells, Units L19344, L22228, L23295, L26460 B-0027-2, Platelets, Unit L26460 B-0028-2, Recovered Plasma, Units L19344, L22228, L23295, L26460 REASON: Blood products, collected from a donor whose arm inspection was not documented, were distributed. MANUFACTURER/RECALLING FIRM: Central Illinois Community Blood Bank, Springfield, IL RECALLED BY: The recalling firm by letter dated May 22, 2001 or July 9, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: IL, MO and Switzerland QUANTITY: 9 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0037-2, Red Blood Cells, unit number 21KH31172 B-0038-2, Cryoprecipitated AHF, unit numbers 21KJ35675 and 21KH31172 B-0039-2, Recovered Plasma, unit numbers 21KJ35675 and 21KH31172 REASON: Blood products, collected from an ineligible donor due to a history of receipt of clotting factor concentrates, were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Pacific Northwest Region, Portland, OR RECALLED BY: The recalling firm by telephone on October 16, 2000, by letter dated October 30, 2000, and by facsimile on October 21, 2000 FIRM INITIATED RECALL: Complete DISTRIBUTION: OR, CA and Switzerland QUANTITY: 5 units h3>E FIELD CORRECTIONS: DEVICES -- CLASS II _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1079-1/Z-1081-1 Codes: A) Stryker Zoom Patient Transport Frame. Model 2040; Serial numbers 0012036662, 0012036663 and 010215001 through 0107037043. B) Stryker Epic II Critical Care bed with Zoom. Model 2030; Serial numbers 010215606 through 0106036627. C) Stryker Secure II Med/Surg bed with Zoom. Model 3002; Serial numbers 0101035906 through 010515421. REASON: Inverter/charger board may catch fire when unplugged from power source. MANUFACTURER/RECALLING FIRM: Stryker Corp. Kalamazoo, MI RECALLED BY: Recalling firm by letter dated July 20, 2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, Brazil and Korea QUANTITY: 271 beds _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0005-2/Z-0006-2, IMMULITE Turbo Troponin I Kit. An in-vitro diagnostic kit for the quuantitative measurement of Troponin I in serum or plasma. Models affected are 100 test kit (LSKTI1 lot 118) and 500 test kit (LSKTI5 lot 118). REASON: Component mix-up in diagnostic kit MANUFACTURER/RECALLING FIRM: Diagnostic Products Corp., Los Angeles, CA RECALLED BY: Manufacturer, by letter dated August 8, 2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Worldwide QUANTITY: 318 100 test kits; 6 500 test kits _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0007-2, Cryocyte Freezing Containers, 250 ml with Label Pocket. Labeled in part, "Immunotherapy Code XXXXXX Cryocyte Freezing Container with Label Pocket 250 ml Capacity*** Baxter Healthcare Corporation, Deerfield IL 60015" Codes: Codes: 4R9953 4R9959 R4R9951 R4R9955 Lots: H98G14462R H98G23463R REASON: Cracking of fill tubing. MANUFACTURER/RECALLING FIRM: Nexell Therapeutics, Inc., Irvine, CA RECALLED BY: Recalling firm sent letters dated 9/10/1998 FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide and Canada. QUANTITY: 103 cases _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0013-2, Behring Coagulation System (BCS) Coagulation Analyzer. Codes: Software Version 2.2 Code OVIO03 REASON: Falsely shortened APTT value. MANUFACTURER/RECALLING FIRM: Dade Behring Marburg GMBH, Marburg, Germany RECALLED BY: Dade Behring, Inc., Newark, DE, by letter on 6/25/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 167 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0016-2, American Medical System Cavernotome C&R Disposable Dilators; set includes 4 sizes of dilators. Codes: Lot Numbers: R11,584/5/6/7 Part Number: 72403293 REASON: Sterile disposable dilators punctured sterile packaging in transit. MANUFACTURER/RECALLING FIRM: Uroan XXI Electromedicina Palma De Mallorca, SP RECALLED BY: American Medical Systems, Inc., Minnetonka, MN, by letter dated September 10, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: 107 Units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0017-2, Chamberlite Emergency Portable Hyperbaric Chamber Labeled: Operation Pressure 15 PSI Codes: Serial numbers: 10, 14, 51, 52, 170, 205, 311, 312, 313, 314, 504, 538, 539, 657, 752, 753, 755, 756, 817, 818, and 820 REASON: Firm is distributing device at a higher psi level than it is approved for. MANUFACTURER/RECALLING FIRM: Hyperbaric Technologies, Inc. Amsterdam, NY RECALLED BY: The firm issued recall letters dated 9/13/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 21 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0018-2, Premier brand Chagas IgG EIA test kits. Codes: Lot # TCE100.012, Exp Date: 4/5/02 REASON: False positive test results. MANUFACTURER/RECALLING FIRM: Meridian Bioscience, Inc., Cincinnati, OH RECALLED BY: Meridian Diagnostics, Inc., Cincinnati, OH, by fax and letter on 8/16/2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: IA, MN, TX and Brazil and Panama Republic. QUANTITY: 859 kits _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0019-2/Z-0023-2, Nipro Safe Touch Safety Fistula Needle Codes: All model numbers and lot numbers are included in this recall. model( Reorder or Catalog numbers) and lot numbers below: REORDER NUMBER LOT NUMBERS FS 152530BC 01B22, 01B26, 01C01, 01C09, 01C16, 01C21,01C17, 01C18, 01C22, 01C24, 01D04, 01D05, 01C30 FS 152530BCR 01C28, 01C30, 01C29, 01D01 FS 162530BC 01B25, 01B26, 01C18, 01C12, 01C14, 01C15, 01C16, 01C17 FS 142530BC 01C27, 01C26, 01C28 FS 172530BC 01C24, 01C23, 01C26 REASON: Needle may separate from the hub of the fistula needle MANUFACTURER/RECALLING FIRM: Nissho Nipro Corp., LTD., Ayuthaya RECALLED BY: Nipro Medical Corporation Miami, FL, by telephone and letter on July 23, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: VA, IL, CO, TN and MA. QUANTITY: 696,500 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0024-2, Gamow Bag, a portable hyperbaric chamber, Codes: All Gamow Bags with S/N's between "31" and "1062" REASON: Unsubstantiated claims for HACE and HAPE MANUFACTURER/RECALLING FIRM: Hyperbaric Technologies, Inc. Amsterdam, NY RECALLED BY: The recalling firm by letters dated 7/20/01 and 8/15/01 to direct accounts. Recall involves removing and replacing pages in the User's Manual. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: CO and Japan, India and NYS QUANTITY: 86 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0028-2, Pediatric Pallet, part number 5239715; an accessory used with the E.CAM Emission Imaging Computed Tomography Systems to adapt the unit for pediatric use for all common nuclear medicine procedures. Codes: All Pediatric Pallets sold as accessories to the following E.CAM Systems: Model 4380221 - E.CAM Gantry Dual Head Variable, serial numbers 0005 through 1215 Model 5242826 - E.CAM Gantry Dual Head Variable, serial numbers 1001 through 3141 and 4001 through 4111 Model 5977066 - E.CAM Gantry Dual Head Variable, serial numbers 4100 through 4178 Model 4380213 - E.CAM Gantry Single Head, serial numbers 0001 through 4016 Model 5977074 - E.CAM Gantry Single Head, serial numbers 4001 through 4031 REASON: Pediatric Pallet plunger end pin may break MANUFACTURER/RECALLING FIRM: Siemens Medical Systems, Inc., Hoffman Estates, IL RECALLED BY: Firm's servicemen replaced defective plunger assembly under Service Bulletin NM010/00/R issued 5/9/00. No end user notification was made. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide. QUANTITY: 28 pallets _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0029-2/Z-0030-2, AccuSync 7 ECG Gating Device/Monitor used as an accessory to the E.CAM family of Emission Imaging Computed Tomography Systems to monitor the patients' cardiac output and act as a trigger during gated cardiac acquisitions; Siemens Medical Systems Inc., Hoffman Estates, IL; two models of monitor were affected by the recall: a) ECG Monitor without Chart Recorder, part 5220327 b) ECG Monitor with Chart Recorder, part 5220335 Codes: Accusync 7 ECG Monitors, Models 7000-3 and 7000-3P, part numbers 5220327 and 5220335 respectively, shipped as accessories with the following cameras: Model 4380221 - E.CAM Gantry Dual Head Fixed, serial numbers 9, 13, 1005 through 1215 Model 5242826 - E.CAM Gantry Dual Head Variable, serial numbers 1001 through 1131 and 2001 through 2082 Model 4380213 - E.CAM Gantry Single Head Fixed, serial numbers 1, 2, 1002 through 1022 and 2002 through 2022 Model 3562357 - Multispect 2 HD3 Gantry, serial numbers 1017, 1028, 1039, 1044, 1046, 1047, 1048 Model 3562332 - Diacam HD3 Gantry Integrated, serial numbers 1001 through 1106 REASON: Monitor generates ECG patterns & traces when not connected to patient MANUFACTURER/RECALLING FIRM: AccuSync Medical Research Corp. Milford, CT RECALLED BY: Siemens Medical Systems, Inc., Hoffman Estates, IL, issued Service Bulletin FMI-281 on 9/30/99 FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide and Worldwide QUANTITY: 432 monitors _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0032-2/Z-0036-2, Boston Scientific Corporation’s Viper Small Vessel Peripheral (Balloon) Dilatation Catheters with Bioslide Hydrophilic Coating, Model Lot Numbers M001192060 4009868 M001192130 4006308 M001192150 4003520, 4009870 M001192020 4003569 M001192110 4003574 REASON: Some units have mid-shaft bond strengths below specifications making it is possible that a distal segment of the catheter may become detached. MANUFACTURER/RECALLING FIRM: Boston Scientific SciMed, Inc., Maple Grove, MN RECALLED BY: Firm issued letters dated 8/2/01 with follow-up visit FIRM INITIATED RECALL: Ongoing DISTRIBUTION: FL, GA, IL, NY, WA and Germany QUANTITY: 22 catheters _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0037-2/Z-0056-2, Airlife Manual Resuscitation Bags, Latex Free; a disposable single patient use device used for pulmonary resuscitation; the immediate container has the warning "IMPORTANT Perform functional test on Resuscitator by squeezing the bag and verifying proper valve action PRIOR TO PLACING IN SERVICE"; Manufactured for Allegiance Healthcare Corporation, IL Codes: Catalog # 2K8001, 2K8005 and 2K8017: all lots beginning with Y9, Y0, Y1A and 04440, 04401, 04634, and all lots between Y1B0000 through Y1B0257 Catalog #2K8008 and 2K8010: Any lot number where the last six digits are prior to 001216, where the digits represent the year, the month and the day, i.e. 2000, DEC 16 and prior Catalog #2K8000, 2K8004, 2K8018, 2K8019, 2K8020, 2K8021, 2K8032, 2K8033, 2K8034, 2K8035, 2K8036, 2K8037, 2K8038, 2K8039 and 2K8040: Any lot number where the last six digits are prior to 010115, i.e. prior to 2001 JAN 15 Custom Sterile kit product numbers packaged with the above listed resuscitation bags include: Kits containing adult resuscitation bags: a) BLK675361A, manufacture dates 03/03/1999, 03/24/1999, 04/12/1999, 05/25/1999 b) BLKOC1026B, manufacture dates 03/02/2001, 03/20/2001 c) PC12CG15A, manufacture date 11/05/1999 d) PC12CG15B, manufacture dates 11/11/1999, 12/21/1999 e) PC12CG15C, manufacture dates 12/21/1999, 01/19/2000, 01/31/2000, 02/08/2000, 02/22/2000, 03/24/2000, 04/13/2000, 04/18/2000, 04/20/2000 f) PC12CG15D, manufacture dates 05/08/2000, 05/10/2000, 05/12/2000 g) PC12CG15E, manufacture date 05/26/2000 h) PC12CG15F, manufacture dates 06/15/2000, 06/20/2000, 06/30/2000, 07/19/2000, 07/25/2000, 08/09/2000, 08/17/2000, 08/23/2000, 08/31/2000, 09/09/2000, 10/02/2000, 10/20/2000, 10/24/2000, 10/31/2000, 11/20/2000, 11/29/2000, 12/02/2000, 12/26/2000, 01/23/2001, 02/02/2001, 02/16/2001, 03/14/2001 i) PC12CGFFZ, manufacture dates 10/22/1999, 11/02/1999 j) PC12VR15A, manufacture dates 12/10/1999, 01/11/2000, 01/31/2000, 03/24/2000, 04/20/2000 k) PC12VR15B, manufacture dates 05/05/2000, 05/20/2000 l) PC12VR15C, manufacture date 05/25/2000 m) PC12VR15D, manufacture dates 06/20/2000, 07/03/2000, 08/02/2000, 08/25/2000, 09/26/2000, 09/28/2000, 11/03/2000, 11/19/2000, 11/29/2000, 12/28/2000, 01/23/2001, 02/02/2001, 02/21/2001, 03/09/2001, 05/14/2001 n) PC12VRFFZ, manufacture date 10/04/1999 o) PC21CGMMQ, manufacture dates 08/16/2000, 10/03/2000 p) PC21CGMMR, manufacture date 11/09/2000 q) PC21CGMMS, manufacture dates 11/17/2000, 11/20/2000 r) PC21CGMMT, manufacture date 01/08/2001 s) PC21CGMMU, manufacture dates 02/08/2001, 03/09/2001 t) PC21HTMMF, manufacture date 07/14/2000 u) PC21HTMMG, manufacture dates 07/17/2000, 08/28/2000, 10/04/2000 v) PC21HTMMH, manufacture date 10/06/2000 w) PC21HTMMI, manufacture dates 11/30/2000, 01/08/2001, 01/30/2001, 03/09/2001 x) PC21HTMMJ, manufacture date 03/22/2001 y) PC21HTMMK, manufacture date 04/25/2001 z) PC21VRMMM, manufacture dates 09/01/2000, 10/11/2000, 11/17/2000, 12/13/2000 aa) PC21VRMMN, manufacture dates 12/20/2000, 12/22/2000 bb) PC23OHAKJ, manufacture dates 12/20/1999, 01/26/2000, 02/16/2000, 03/21/2000, 05/12/2000 cc) PC23OTMUB, manufacture dates 01/11/2000, 01/20/2000, 02/22/2000, 03/13/2000, 04/25/2000, 05/17/2000, 06/07/2000, 07/18/2000, 08/09/2000, 08/22/2000, 10/04/2000, 11/21/2000, 11/27/2000, 11/29/2000, 12/08/2000, 01/05/2001, 12/22/1999R dd) PC43CGSPB, manufacture date 05/09/2000 ee) PC73OHASJB, manufacture date 05/11/2001 ff) PC73OHSJA, manufacture dates 04/03/2001, 04/16/2001 gg) PC73OHSJB, manufacture dates 05/04/2001, 05/07/2001 hh) PV12AAFFJ, manufacture dates 08/06/1999, 09/08/1999, 09/27/1999, 12/14/1999, 01/14/2000, 02/02/2000, 02/25/2000, 04/11/2000, 04/21/2000 ii) PV12AAFFK, manufacture date 05/24/2000 jj) PV12AAFFL, manufacture dates 06/07/2000, 07/27/2000, 11/20/2000, 01/17/2001, 02/23/2001 kk) PV12AAFFM, manufacture date 05/09/2001 ll) PV12CVUME, manufacture dates 10/22/1999, 10/28/1999, 11/10/1999, 11/15/1999 mm) PV12CVUMF, manufacture dates 12/09/1999, 01/11/2000 nn) PV12CVUMG, manufacture dates 02/01/2000, 02/24/2000, 02/25/2000, 03/08/2000 oo) PV12CVUMH, manufacture dates 03/28/2000, 04/15/2000, 04/26/2000, 05/01/2000, 05/11/2000, 05/13/2000, 05/18/2000, 06/01/2000, 06/14/2000, 06/26/2000 pp) PV12CVUMI, manufacture dates 07/11/2000, 08/04/2000, 08/25/2000, 09/26/2000, 10/09/2000, 10/12/2000, 10/20/2000, 11/07/2000, 12/18/2000, 12/23/2000, 01/12/2001, 02/13/2001, 02/22/2001, 03/19/2001, 04/23/2001, 05/23/2001, 05/31/2001 qq) RE1239086A, manufacture date 06/08/2000 rr) RES131431A, manufacture dates 12/17/1998, 12/17/1998, 12/17/1998 ss) RES215902D, manufacture dates 09/14/2000, 12/09/2000 tt) RES232917A, manufacture dates 12/08/1999, 03/08/2000, 04/29/2000 uu) RES235488B, manufacture dates 04/06/1999, 04/09/1999, 06/03/1999, 08/19/1999, 10/27/1999, 12/01/1999, 12/27/1999, 02/17/2000, 05/03/2000, 09/20/2000, 12/26/2000, 01/11/2001, 03/13/2001, 05/14/2001 vv) RES361278A, manufacture dates 11/12/1998, 11/25/1998, 12/11/1998, 03/09/1999, 04/20/1999, 06/02/1999, 07/19/1999, 08/19/1999, 10/01/1999, 10/27/1999, 11/15/1999, 12/09/1999 ww) RES365784A, manufacture dates 03/01/1999, 03/26/1999, 04/26/1999, 05/12/1999, 06/10/1999, 08/06/1999, 08/19/1999, 09/02/1999, 10/28/1999, 12/08/1999, 07/12/2001 xx) RES377177C, manufacture dates 11/24/1998, 01/06/1999, 01/06/1999, 07/12/1999, 08/12/1999, 09/15/1999, 10/21/1999, 12/10/1999, 01/25/2000, 01/28/2000, 03/29/2000 yy) RES411065A, manufacture dates 12/01/1998, 12/01/1998, 01/05/1999, 01/05/1999, 01/05/1999, 01/11/1999, 01/11/1999, 01/11/1999, 02/16/1999, 02/16/1999, 02/16/1999, 03/26/1999, 03/26/1999, 03/26/1999, 05/01/1999, 05/13/1999, 05/13/1999 zz) RES413580A, manufacture date 11/30/1998 aaa) RES459293A, manufacture date 03/02/2001 bbb) RES459293B, manufacture date 03/02/2001 ccc) RES731619B, manufacture dates 06/20/2001, 07/12/2001 ddd) RES90RESUB, manufacture dates 04/13/1999, 04/23/1999 eee) RESOC1026A, manufacture dates 12/15/1998, 01/08/1999, 02/09/1999 fff) RESOC1431B, manufacture dates 01/14/1999, 03/09/1999, 05/12/1999, 07/09/1999, 10/01/1999, 12/20/1999 ggg) RESOC5849A, manufacture dates 11/16/1998, 11/16/1998, 12/15/1998, 12/15/1998, 01/11/1999, 01/11/1999, 02/23/1999, 02/23/1999, 04/01/1999, 04/01/1999, 05/14/1999, 05/14/1999, 06/24/1999, 06/24/1999, 09/13/1999, 09/13/1999 hhh) RESOC-6120, manufacture dates 11/20/1998, 01/07/1999, 02/02/1999 iii) RESOC6120C, manufacture dates 04/27/1999, 06/02/1999, 06/02/1999, 07/15/1999, 07/15/1999, 08/25/1999, 08/25/1999, 10/12/1999, 10/12/1999, 11/11/1999, 11/11/1999, 02/02/2000, 02/02/2000 jjj) RESOC7180A, manufacture dates 04/07/1999, 05/12/1999, 06/18/1999 kkk) RESOC7692A, manufacture dates12/09/1998, 12/09/1998 lll) RPK218814A, manufacture dates 11/02/2000, 11/16/2000, 11/30/2000, 01/02/2001, 01/17/2001, 02/07/2001, 02/21/2001, 03/27/2001 mmm) RPS411211B, manufacture dates 11/16/2000, 11/28/2000 nnn) RPS670132B, manufacture date 09/12/2000 ooo) SPK218814A, manufacture dates 07/13/2000, 08/07/2000 ppp) SPK417242A, manufacture dates 06/21/2000, 06/30/2000 kits containing pediatric resuscitation bag a) PRES461932, manufacture dates 11/10/1998, 11/30/1998, 03/04/1999, 03/09/1999 b) RE1365784A, manufacture dates 03/31/2000, 03/31/2000, 03/28/2001, 03/28/2001 c) RE1OC5445A, manufacture date 07/13/2001 d) RE1VF0326A, manufacture dates 03/12/2001, 03/12/2001 e) RES239086A, manufacture dates 02/11/2000, 03/10/2000, 05/25/2000, 06/08/2000, 11/03/2000 f) RESOC7004A, manufacture date 03/12/2001 g) SP1215902C, manufacture dates 06/14/2000, 08/02/2000, 09/19/2000, 10/31/2000, 11/13/2000, 01/15/2001, 03/07/2001, 06/30/2001 REASON: Resuscitation bags may not allow proper duck bill valve action MANUFACTURER/RECALLING FIRM: Engineered Medical Systems, Inc. Indianapolis, IN RECALLED BY: Allegiance Healthcare Corporation McGaw Park, IL, by Federal Express, on 8/6/01 FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: 2,076,594 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0058-2, Laser Doppler Flowmeter, PF 5001 Main Unit; a Blood Flow Meter. Used for housing Laser Doppler Blood Perfusion modules: PF 5010 Laser Doppler Module, or PF 5040 Transcutaneous Oxygen Module. Codes: Serial Numbers: 1196 and 1199 REASON: A low output level from the laser light will result in device failure during use MANUFACTURER/RECALLING FIRM: Perimed AB Jarfalla - Sweden RECALLED BY: PeriMed, Inc., North Royalton, OH, by telephone on 1/25/2001, and letter on 2/2/2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ and IL QUANTITY: 2 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0060-2, Constellation brand Multiple Electrode Recording and Pacing Catheter. Codes: All lots affected. REASON: Product may be contaminated with small fibers on the distal tip of the catheter. MANUFACTURER/RECALLING FIRM: Boston Scientific Corp. San Jose, CA RECALLED BY: Recalling firm, via telephone on July 5, 2001 and letter on July 13, 2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and worldwide QUANTITY: 4,416 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0061-2, IsoMed Constant-Flow Infusion System Clinical Reference Guide for Pain Therapy, Product Catalog Number 182369-102/UC1999901594a EN NP3821 Codes: Lot number: None (clinical guides do not have lot numbers) REASON: Clinical guides given to physicians to aid their management of patients with IsoMed pumps lack a warning statement. MANUFACTURER/RECALLING FIRM: Medtronic, Inc., Neurological Division, Minneapolis, MN RECALLED BY: Recalling firm by letter dated July 26, 2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 102 Reference Guides _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0062-2, AxSYM Total T4 Reagent AxSYM Total T4 is a Fluorescence Polarization Immnunoassay (FPIA) for the quantitative determination of thyroxine (T4) in human serum or plasma. This include both protein-bound and unbound forms of thyroxine. The AxSYMm Total T4 assay is used as an aid in the assessment of thyroid status. Codes: List No.: 7A55-20 Lot No.: 70892Q100, 70892Q101 and 70892Q102 Exp. Date: 10/12/2001 REASON: Failure to calibrate the assay when using these reagents lots MANUFACTURER/RECALLING FIRM: Abbott Health Products, Inc., Barceloneta, PR RECALLED BY: Recalling firm by letter dated 8/2/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Worldwide QUANTITY: 11,259 kits _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0067-2, NORMOCARB (Sterile Bicarbonate Renal Dialysis Concentrate). Lots 1A530, 1A620, 1A940, 1B270, 1B280, 1C330, GA0951, GA1188, GA1190 and GA2889 Codes: REASON: Contaminated with microorganism MANUFACTURER/RECALLING FIRM: Dialysis Solutions, Inc. Richmond Hills, Ontario, Canada RECALLED BY: Novex Pharma Richmond Hills, Ontario, Canada, FIRM INITIATED RECALL: Ongoing DISTRIBUTION: AL, CA, MA, MS, NY, NC, PA QUANTITY: Approx. 330 cases _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0068-2, Depuy brand PFC Sigma Knee System fluted femoral stem, 18 mm x 175 mm. Catalog number 96-1713, Lot 099495. Codes: Depuy brand PFC Sigma Knee System fluted femoral stem, 18 mm x 175 mm. Catalog number 96-1713, Lot 099495. REASON: Mislabeled as to size MANUFACTURER/RECALLING FIRM: Depuy Orthopaedics, Inc., Warsaw, IN RECALLED BY: Recalling firm by telephone on February 5, 2001 and letter dated February 19, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: FL, LA, ME, MO, NV and England QUANTITY: 20 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0069-2/Z-0072-2, Junction Box, a component of Invacare Electric Beds, AC-Powered Adjustable Hospital. Codes: All affected junction boxes are identified with the date of manufacture from 8/1/1998 thru 10/31/2000. REASON: A faulty junction box may overheat, and result in electrical failure with potential fire hazard. MANUFACTURER/RECALLING FIRM: Invacare Corp. Sanford, FL RECALLED BY: Invacare Corp. Elypia, OH, by letter on 8/31/2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Worldwide QUANTITY: 222,022 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0074-2/Z-0087-2, COBE Cardioplegia Delivery Sets (may also be labeled as the Sorin brand, the Dideco brand or be contained in COBE Heart Lung packs). Codes: Part # Lot # 032746002 11FO147, 12F0392,0101100069, 0106900012 020947601 12F0811MP 027812201 03F0641, 05F0502, 07F0610, 09F0729, 10F0678, 10F0679, 12F0585, 12F0584, 0102900082, 0108900150 027819201 03F0607, 07F0563, 09F0571, 10F0640, 11F0536, 12F0575, 12F0623, 12F0735, 0100300115, 0102200123, 0103600060, 0104000060, 0104600104 0109500149, 0111000065, 0111600084. 067239001 0109300036 078722004 0107400098, 0109500184, 0113000058, 0100300153 078838003 09F0002, 11F0003, 0103600100, 0105700186, 0107400102. 078860004 01G0087, 01G0001. 078920001 0105700236 078939001 0110100019 078722002 03F0232, 06F0159, 08F0011, 08F0348, 10F0368, 11F0348. 027816201 05F0571, 07F0565, 08F0654, 09F0631. 027840201 01F0595, 02F0715. 025735403 10F0529MP. REASON: Tubing subassembly assembled with wrong size tubing. MANUFACTURER/RECALLING FIRM: COBE CARDIOVASCULAR, INC. ARVADA, CO RECALLED BY: Recalling firm, by letter on 5/24/2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, Canada and Italy QUANTITY: 2566 sets _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0088-2, Human Dura Mater Allograft, packaged in bottles, and labeled in part: "HUMAN FREEZE DRIED ETHYLENE OXIDE STERILIZED DURA MATER" Codes: This code is on the label as "Deposit Number:", front face. D-17048-000-1998 D-17049-000-1998 D-17050-000-1998 D-17051-000-1998 D-17053-000-1998 D-17126-000-1998 D-17131-000-1998 D-17212-000-1998 D-17213-000-1998 D-17214-000-1998 D-17216-000-1998 D-17217-000-1998 D-17218-000-1998 D-17219-000-1998 D-17220-000-1998 D-17230-000-1998 D-17231-000-1998 D-17232-000-1998 D-17233-000-1998 D-17282-000-1998 D-17283-000-1998 D-17284-000-1998 D-17285-000-1998 D-17286-000-1998 D-17287-000-1998 D-17307-000-1998 D-17308-000-1998 D-17309-000-1998 D-17346-000-1998 D-17347-000-1998 D-17348-000-1998 D-17349-000-1998 D-17350-000-1998 D-17359-000-1998 D-17360-000-1998 D-17361-000-1998 D-17362-000-1998 D-17363-000-1998 D-17364-000-1998 D-17387-000-1998 D-17388-000-1998 D-17389-000-1998 D-17390-000-1998 D-17391-000-1998 D-17530-000-1998 D-17531-000-1998 D-17532-000-1998 D-17533-000-1998 D-17534-000-1998 D-17535-000-1998 D-17536-000-1998 D-17551-000-1998 D-17552-000-1998 D-17553-000-1998 D-17554-000-1998 D-17555-000-1998 D-17556-000-1998 D-17557-000-1998 D-17558-000-1998 D-17559-000-1998 D-17579-000-1998 D-17580-000-1998 D-17581-000-1998 D-17582-000-1998 D-17612-000-1998 D-17613-000-1998 D-17614-000-1998 D-17615-000-1998 D-17625-000-1998 D-17626-000-1998 D-17627-000-1998 D-17628-000-1998 D-17629-000-1998 D-17630-000-1998 D-17675-000-1998 D-17676-000-1998 D-17677-000-1998 D-17678-000-1998 D-17679-000-1998 D-17680-000-1998 D-17699-000-1998 D-17700-000-1998 D-17701-000-1998 D-17707-000-1998 D-17708-000-1998 D-17709-000-1998 D-17710-000-1998 D-17730-000-1998 D-17731-000-1998 D-17756-000-1998 D-17761-000-1998 D-17762-000-1998 D-17763-000-1998 D-18320-000-1998 D-18321-000-1998 D-18322-000-1998 D-18323-000-1998 D-18325-000-1998 D-18326-000-1998 D-18327-000-1998 D-18593-000-1999 D-18594-000-1999 D-18595-000-1999 D-18596-000-1999 D-18599-000-1998 D-18600-000-1998 D-18601-000-1998 D-18602-000-1998 D-18603-000-1998 D-18607-000-1998 D-18608-000-1998 D-18609-000-1998 D-18610-000-1998 D-18611-000-1998 D-18612-000-1998 D-18613-000-1998 D-18615-000-1998 D-18616-000-1998 D-18618-000-1998 D-18619-000-1998 D-18621-000-1998 D-18622-000-1998 D-18636-000-1998 D-18637-000-1998 D-18638-000-1998 D-18639-000-1998 D-18640-000-1998 D-18642-000-1998 D-18643-000-1998 D-18644-000-1998 D-18645-000-1998 D-18646-000-1998 D-18756-000-1998 D-18757-000-1998 D-18758-000-1998 D-18759-000-1998 D-18760-000-1998 D-18761-000-1998 D-18762-000-1998 D-18764-000-1998 D-18765-000-1998 D-18766-000-1998 D-18767-000-1998 D-18768-000-1998 D-18769-000-1998 D-18771-000-1998 D-18772-000-1998 D-18773-000-1998 D-18774-000-1998 D-18775-000-1998 D-18789-000-1998 D-18790-000-1998 D-18791-000-1998 D-18792-000-1998 D-18793-000-1998 D-18809-000-1998 D-18810-000-1998 D-18811-000-1998 D-18812-000-1998 D-18813-000-1998 D-18814-000-1998 D-18820-000-1999 D-18822-000-1999 D-18823-000-1999 D-18824-000-1999 D-18825-000-1999 D-18826-000-1999 D-18896-000-1999 D-18897-000-1999 D-18898-000-1999 D-18899-000-1999 D-19012-000-1999 D-19013-000-1999 D-19014-000-1999 D-19015-000-1999 D-19030-000-1999 D-19031-000-1999 D-19032-000-1999 D-19033-000-1999 D-19034-000-1999 D-19035-000-1999 D-19037-000-1998 D-19038-000-1998 D-19039-000-1998 D-19040-000-1998 D-19041-000-1998 D-19057-000-1998 D-19059-000-1998 D-19078-000-1998 D-19079-000-1998 D-19080-000-1998 D-19081-000-1998 D-19082-000-1998 D-19545-000-1999 D-19546-000-1999 D-19547-000-1999 D-19548-000-1999 D-19549-000-1999 D-19850-000-1999 D-19851-000-1999 D-19852-000-1999 D-19853-000-1999 D-19854-000-1999 D-19861-000-1999 D-19862-000-1999 D-19863-000-1999 D-19864-000-1999 D-19874-000-1999 D-19875-000-1999 D-19878-000-1999 D-19879-000-1999 D-19880-000-1999 D-19882-000-1997 D-19883-000-1997 D-19893-000-1999 D-19894-000-1999 D-19895-000-1999 D-19900-000-1999 D-19901-000-1999 D-19902-000-1999 D-19903-000-1999 D-20394-000-2000 D-20395-000-2000 D-20396-000-2000 D-20397-000-2000 D-20408-000-1999 D-20409-000-1999 D-20410-000-1999 D-20411-000-1999 D-20412-000-1999 D-20413-000-1999 D-20414-000-1999 D-20416-000-1999 D-20417-000-1999 D-20464-000-1999 D-20465-000-1999 D-20466-000-1999 D-20467-000-1999 D-20468-000-1999 D-20470-000-1999 D-20471-000-1999 D-20472-000-1999 D-20473-000-1999 D-20475-000-1999 D-20476-000-1999 D-20477-000-1999 D-20484-000-1999 D-20485-000-1999 D-20486-000-1999 REASON: Dura Mater with Residual Endotoxin level above 0.06EU/ml MANUFACTURER/RECALLING FIRM: University of Miami Tissue Bank Miami, FL RECALLED BY: Transportation Research Foundation, Bellaire, TX, by letter dated 7/2/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 249 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0089-2, Profile MD V-186HV3 Implantable Cardioverter Defibrillator Codes: Profile MD Model V186HV3, Implantable defibrilator. REASON: Capacitor may short MANUFACTURER/RECALLING FIRM: St. Jude Medical, Inc., Sylmar, CA RECALLED BY: Recalling firm by FEDEX FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, Europe, Latin America, Australia and Canada QUANTITY: 771 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0090-2/Z-0176-2, All lots of all cassettes for the listed products that do not bear a green or white sticker with arrows pointing up and the words "store upright" on the sticker are under recall. Codes: Roche COBAS Integra Invitro diagnostics for use on Roche COBAS Integra 400, 700 or 800 clinical chemistry analyzers, as follows: 1. AAGP [Alpha-1-Acid Glycoprotein], Ref 2 0750913 2. AAT [Alpha-1-Antitrypsin], Ref 2 0750921 3. ACETA [Acetaminophen], Ref 2 0767174 4. ACPP [Acid/Prostatic Phosphatase], Ref 20737321 5. ALB [Albumin], Ref 2 0737461 6. ALB-T[ Albumin] Ref 2 0737674 7. ALPL6 [Alkaline Phosphatase], Ref 2 0759961 8. ALTL [Alanine Transaminase], Ref 2 0764957 9. ALPL2 [Alk Phosphatase], Ref 2 0766739 10. AMIKM [Amikacin], Ref 2 0767166 11. AMYLL [Amylase], Ref 2 0759988 12. AMY-P [Amylase Pancreatic], Ref 2 0766623 13. APOA [Apolipoprotein A-1], Ref 2 0737682 14. APOB [Apolipoprotein B], Ref 2 0737690 15. ASO [Anti-Streptolysin O], Ref 2 0750948 16. ASTL [Aspartate Aminotransferase], Ref 2 0764949 17. AT3 [Antithrombin III], Ref 2 0751731 18. BIL-D [Direct Bilirubin], Ref 2 0737496 19. BIL-T [Total Bilirubin], Ref 2 0737488 20. C3C [Complement C3c], Ref 2 0737712 21. C4 [Complement C4], Ref 2 0737720 22. CA [Calcium], Ref 2 0763128 23. CARB [Carbamazepine], Ref 2 0737828 24. CERU [Ceruloplasmin], Ref 2 0764663 25. CHE [Cholesterase], Ref 2 0737380 26. CHECK [Check Cassette], Ref 2 0757136 27. CHOLL [Cholesterol], Ref 2 0763012 28. CKL [Creatine Kinase], Ref 2 0759236 29. CKMBL [Creatine Kinase-MB], Ref 2 0759244 30. CLEAN [Cleaner Cassette], Ref 2 0764337 31. CO2-S [Carbon dioxide] Ref 2 0766763 32. CREAE [Creatinine Enzymatic], Ref 2 0763144 33. CREAJ [Creatinine Jaffee], Ref 2 0764345 34. CREAP [Creatinine Plus], Ref 2 3029565 35. CRPLX [C-Reactive Protein (Latex)], Ref 2 0764930 36. CSA [Cyclosporine], Ref 2 0753564 37. D-DI [Tina-quant, D-Dimer], Ref 2 3001245 38. DIG [Digoxin], Ref 2 0737836 39. ETOH [Ethanol], Ref 2 0737550 40. FERR [Ferritin], Ref 2 0753556 41. FPCAL [Fp-Calibration], Ref 2 0755346 42. FRA [Fructosamine], Ref 2 0737569 43. GENT [Gentamicin], Ref 2 0737844 44. GGTL [Glutamyltransferase], Ref 2 0759996 45. GLUCL [Glucose HK liquid], Ref 2 0763020 46. HAPT [Haptoglobin], Ref 2 0737747 47. HBA1C [Hemoglobin A1c], Ref 2 0753521 48. HDL-D [HDL Cholesterol Direct], Ref 2 0764558 49. IGA [Immunoglobulin A], Ref 2 0737755 50. IGGT [Immunoglobulin G (turb.)], Ref 2 0766631 51. IGM [Immunoglobulin M], Ref 2 0737771 52. IRON [Iron], Ref 2 0737585 53. LACT [Lactate], Ref 2 0757225 54. LDHI [Lactate dehydrogenase], Ref 2 0759813 55. LDL-D [LDL Cholesterol Direct], Ref 2 0766747 56. LIDO [Lidocaine], Ref 2 0757241 57. LIPC [Lipase Colorimetric], Art 0759007 58. LIPL [Lipase], Ref 2 0763004 59. MG [Magnesium], Ref 2 0737593 60. MYO [Myoglobin], Ref 2 0753548 61. NAPA [N-Acetyl Procainamide], Ref 2 0737852 62. NH3L [Ammonia], Ref 2 0766682 63. PHNO [Phenobarbital], Ref 2 0737860 64. PHNY [Phenytoin], Ref 2 0737879 65. PHOS [Phosphate (inorganic)], Ref 2 0737607 66. PREA [Prealbumin], Ref 2 0764655 67. PRIM [Primidone], Ref 2 0737887 68. PROC [Procainamide], Ref 2 0737895 69. QUIN [Quinidine], Ref 2 0737909 70. RF II [Rheumatoid Factors II], Ref 2 0764574 71. SALI [Salicylate], Ref 2 0753580 72. SBARB [Barbiturates Reagent Kit], Ref 2 0766704 73. SBENZ [Benzodiazepines Reagent Kit], Ref 2 0766690 74. STFR [Tina-quant, soluble transferrin receptor], Ref 2 0763454 75. THEO [Theophylline], Ref 2 0737917 76. TOBR [Tobramycin], Ref 2 0737925 77. Total T4 [Thyroxine], Art 0739006 78. TP [Total Protein], Ref 2 0737615 79. TPU-C [Total Protein Urine/CSF], Ref 2 0757233 80. TRIGL [Triglycerides], Ref 2 0767107 81. TRSF [Transferrin], Ref 2 0737798 82. T-UP [T-Uptake], Art 0739014 83. UA [Uric Acid], Ref 2 0756296 84. UIBC [Unsaturated Iron-Binding Capacity], Ref 2 0737631 85. UREAL [Urea/BUN], Ref 2 0763039 86. VALP [Valproic Acid], Ref 2 0737933 87. VANC [Vancomycin], Ref 2 0737941 REASON: Bottles may leak and result in incorrect results MANUFACTURER/RECALLING FIRM: Roche Diagnostics GmbH Mannheim, Germany RECALLED BY: Roche Diagnostics Corp., Indianapolis, IN by urgent product removal bulletin dated 9/4/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 87 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0177-2/Z-0178-2, Procyon Bedside Monitors, Models BSM-4104A and BSM- 4114A. Codes: Models BSM-4104A and BSM-4114A Bedside Monitors. REASON: Software causes infusion rate 2.2 times proper rate. MANUFACTURER/RECALLING FIRM: Nihon Kohden, Inc., CA RECALLED BY: Recalling firm by telephone and letter on September 12, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 96,88 to hospitals and 8 to dealers for demonstration unitsRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0026-2, VITROS Chemistry Slides - BUN/UREA DT Slides 25 slides per box, Responsible firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, NY, Codes: Lot Number: 0154-0536-2869 REASON: Lot # and exp. date on some cartons is unreadable MANUFACTURER/RECALLING FIRM: Ortho-Clinical Diagnostics, Inc., Rochester, NY RECALLED BY: Recalling firm, by letter dated 8/10/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Australia, Canada, India, Japan and Singapore QUANTITY: 2,628 cartons _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0027-2, IVD Transferrin Receptor Assay (TfR)kit; In vitro enzyme immunoassay for quantifying the concentration of transferrin receptor in human serum or plasma to aid in the diagnosis of iron deficiency anemia. Codes: Catalog number TF-94, Kit Lot #s: TF-94-36 and TF-94-37, HRP- Conjugate (component) Lot #306149. REASON: IVD product for TfR with controls out of range MANUFACTURER/RECALLING FIRM: Ramco Laboratories, Inc., Stafford, TX RECALLED BY: Firm, by letter and telephone on 6/7/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: WA, MD, GA, IA, NY and Denmark, Italy, Hong Kong, Germany, Bangladesh, Netherlands and Switzerland QUANTITY: 99 kits _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0031-2, Motion Electronics Computer Chassis (MECC) Backplanes installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL Codes: MECC Backplane "2104938 REV C" -- a component in the following cameras a) Model 4380221 - E.CAM Gantry Dual Head, serial numbers 00005, 01007A, 01008A, 01141, 01181 through 01215 b) Model 5242826 - E.CAM Gantry Dual Head, serial numbers 01001 through 01075 c) Model 4380213 - E.CAM Gantry Single Head, serial numbers 01002 through 01014 REASON: Backplane traces become overheated, causing CT camera to become inoperable MANUFACTURER/RECALLING FIRM: Siemens Medical Systems, Inc., Hoffman Estates, IL RECALLED BY: Recalling firm issued Service Bulletin on 4/11/00. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Worldwide QUANTITY: 111 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0057-2, Marconi MX8000 Computed Tomography X-ray System. Codes: All Marconi MX8000 CT Scanners running with Version 2.0 sofware. REASON: A software anomaly in ver 2.0 software may result in improper patient diagnosis. MANUFACTURER/RECALLING FIRM: Marconi Medical Systems, Inc., Highland Heights, OH RECALLED BY: The firm by letter, dated 8/10/2000 FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide and Brazil QUANTITY: 76 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0059-2, Valleylab E6019 Bipolar Footswitch, Lot #498238. Codes: Catalog Number: E6019, Lot Number:498238 REASON: Footswitch will intermittently stick in the ON (activated) position. MANUFACTURER/RECALLING FIRM: Valleylab, Inc., Boulder, CO RECALLED BY: Recalling firm via letter on 06/08/2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: 80 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0063-2, Roche Tina-quant IgA. Catalog # 1931687; all lots. The product is an invitro diagnostic for the determination of human IgA. Z-0064-2, Roche Tina-quant IgE. Catalog # 1931725; all lots. The product is an invitro diagnostic for the determination of IgE. Z-0065-2, Roche Tina-quant IgG. Catalog # 1931695; all lots. The product is an invitro diagnostic for the determination of human IgG. Z-0066-2, Roche Tina-quant IgM. Catalog # 1929305; all lots. The product is an invitro diagnostic for the determination of human IgM. Codes: All lots of Tina-quant IgA (catalog # 1931687), IgE(catalog # 1931725), IgG(catalog # 1931695) and IgM(catalog # 1929305) in vitro diagnostic reagents. REASON: Monoclonal gammopathies may exhibit high dose hook effect below label conc. MANUFACTURER/RECALLING FIRM: Roche Diagnostics GmbH Mannheim, Germany, RECALLED BY: Roche Diagnostics Corp., Indianapolis, IN, sent an Urgent Product Bulletin dated 9/17/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: United States QUANTITY: Approximate 8000 kitsEND OF ENFORCEMENT REPORT FOR OCTOBER 24, 2001.
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