September 19, 2001 01-37
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-547-1, Fresh, halved and seeded Red Bell Peppers in 5 pound plastic bags, Codes: Use by date of 2/11/01 or before. REASON: The product was contaminated with Listeria monocytogenes. MANUFACTURER/RECALLING FIRM: Farmer's Best International LLC Rio Rico, RECALLED BY: Boskovich Fresh Cut Oxnard, CA, by telephone on February 8, 2001 FIRM INITIATED RECALL Completed DISTRIBUTION: Southern CA QUANTITY: 20 cases equaling 200 pounds
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-546-1, Snack bar in a metalized/poly film candy wrapper labeled in part: "BUMBLE BAR ORGANIC ENERGY Chocolate Crisp Net Wt 1.6oz*** Ingredients:***Organic dairy-free chocolate***" Codes: The following affected lot codes are printed on the exterior of the case near the label, on the carton bottom or inside the flap of the carton: 21802, 22302, 31402, 31702, 32202, 32402, 32902, 40602, 41202, 41902,42302, 42602,51602, and 52302. REASON: Product contains undeclared milk. MANUFACTURER/RECALLING FIRM: Golden Temple, Inc. Eugene, OR RECALLED BY: Manufacturer, by letter, telephone, and press release on 8/7/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: WA, CA, CO, FL, IN, AZ> QUANTITY: 83 cases, 19,920 individual units _________________________________ RECALL NUMBER, PRODUCT AND CODE: F-548-1, Vitarroz Naranja Agria Bitter Orange in 24 oz. bottles, REASON: The product contained undeclared FD&C Yellow No. 6. MANUFACTURER/ RECALLING FIRM: Roduvisa-Cagua, Venezuela RECALLED BY: Vitarroz Corp., Jersey City, NJ, by telephone on March 20, 2001 FIRM INITIATED RECALL: Completed DISTRIBUTION: NY, NJ, PA, MA QUANTITY: 421 cs. x 12/24oz bottles ______________________________ RECALL NUMBER, PRODUCT AND CODE: a) F-549-1, Uncle Ray's Sour Cream & Onion Flavored Puffs packaged in 2.0 oz. and 5.0 oz. bags. b) F-550-1, Cabana Onion Flavored Rings packaged in 4.5 oz. bag. Codes: All lots manufactured from 1/1/01 to 7/12/01. REASON: The products contained undeclared FD&C Yellow No. 5. MANUFACTURER/RECALLING FIRM: Jenkins Foods, LLC Dearborn, MI RECALLED BY: Jenkins Foods, LLC, Detroit, MI recalled the product by telephone beginning on 7/12/01 followed by a letter on the same date. FIRM INITIATED RECALL: Completed DISTRIBUTION: IN, KY, MI, OH, TN, and Canada QUANTITY: a) 2,760 bags, 2.0 oz each; b) 3,630 bags, 5.0 oz each; c) 390 bags, 4.5 oz eachRECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
______________________________ RECALL NUMBER, PRODUCT AND CODE: F-551-1, Ritchey's Strawberry Ice Cream; F-552-1, Black Raspberry Ice Cream. The products are sold in 5 quart, one half gallon, and one pint sizes. Codes: The product is not coded so all products shipped between April 1, 2001 and June 11, 2001 are included in the recall. REASON: Strawberry ice cream contains undeclared Red #3 and Red #40. Black raspberry contains undeclared Red #40 and Blue #1. MANUFACTURER/RECALLING FIRM: Ritchey's Dairy, Inc. Martinsburg, PA RECALLED BY: Recalling Firm, by visit on June 12, 2001 and by letteron June 18, 2001 FIRM INITIATED RECALL: Completed DISTRIBUTION: PA QUANTITY: 209 units
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
_______________________________ RECALL NUMBER, PRODUCT AND CODE: D-299-1 a) Good Sense brand Children's Pain Reliever, acetaminophen suspension liquid, great tasting rich cherry flavor, 4 fl oz (118 mL), 80mg per 1/2 teaspoon, OTC, NDC #01130-175-26, Perrigo, Allegan, MI b) Kroger brand Children's Pain Reliever, Acetaminophen Pain Reliever, Fever Reducer, Suspension Liquid, Rich Cherry Flavor, 4 FL OZ (118 mL), 80 mg per 1/2 teaspoon, OTC, NDC #30142-175-26, Distributed by the Kroger Co., Cincinnati, Ohio c) Hy-Vee brand Children's Non-Aspirin, Pain Relief Suspension Liquid, Acetaminophen, Rich Cherry Flavor, 80 mg per 1/2 teaspoon (160 mg per 5 ml), 4 FL OZ (118 mL), OTC, NDC #42507-175-26, Distributed by Hy-Vee, Inc., West Des Moines, IA Codes: a), b) and c) Lot #1AD0228 REASON: SUPER-POTENT (ACETAMINOPHEN) MANUFACTURER/RECALLING FIRM: Perrigo Company Allegan, MI RECALLED BY: Manufacturer, by letter on 6/25/01 and press release on 8/15/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: United States QUANTITY: a), b) and c) 7,788 units totalRECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
______________________________ RECALL NUMBER, PRODUCT AND CODE: D-059-1Tegretol® (Carbamazepine USP) 200 mg tablets, in bottles of 100 and 1000 tablets, Rx product Initial 10 lots recalled on 9/18-11/27/00: 150B2289 (10/2002), 155B2289 (10/2002), 121B9991 (4/2002), 128B1120 (6/2002), 137B1238 (6/2002), 144B1825 (8/2002), 156B3063 (10/2002), 158B3063 (10/2002),170D4247 (1/2003), 1T237018 (9/2001). First extension (2/2001):179D5121 (2/2003) - bottles of 100s 179D5216 (2/2003) - bottles of 1000s Second Extension (8/9/01):Lot 232E9126 (exp. 3/2004) - bottles of 1000s Third Extension (9/6/01):Lot 205D6684 (9/2003) – bottles of 1000s Lot 206D6684 (9/2003) – bottles of 1000s REASON: Dissolution Failure< MANUFACTURER/RECALLING FIRM: Novartis Pharmaceuticals, Corp., Suffern, New York RECALLED BY: Manufacturer, by "Urgent: Drug Product Recall" letters on 9/6/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Puerto Rico. QUANTITY: Recall now covers a total of 15 lots. A total of 172,586 bottles (150,223 bottles of 100s and 22,363 bottles of 1000s) for the 10 initial lots of Tegretol® 200 mg were distributed (by lot) as follows: Lot #150B2289: 3784 bottles of 1000s Lot #155B2289: 3787 bottles of 1000s Lot #121B9991: 3641 bottles of 1000s Lot #128B1120: 36,734 bottles of 100s Lot #137B1238: 3750 bottles of 1000s Lot #144B1825: 3756 bottles of 1000s Lot #156B3063: 37,444 bottles of 100s Lot #158B3063: 38,137 bottles of 100s Lot #170D4247: 37,908 bottles of 100s Lot #1T237018: 3645 bottles of 1000s First Extension (2/5/01): Lot #179D5216: 2689 bottles of 1000s Lot #179D5121: 11,047 bottles of 1000s.. Second Extension (8/9/01): Lot 232E9126: 3823 bottles. *** Third Extension (9/6/01):Lot 205D6684: 3814 bottles. Lot 206D6684: 3752 bottles. _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-297-1Temodar Capsules (Temozolomide) 250mg, 20 capsules per bottle, Lot Number 9-PHT-4, Exp. Date August 2002. Rx only Each bottle packaged in an individual folding carton, for oral administration, Rx only. Codes: Lot# 9-PHT-4 Exp. August 2002 REASON: UNDER FILLED CAPSULES MANUFACTURER/RECALLING FIRM: University of Iowa - College of Pharmacy, Iowa City, IA RECALLED BY:Schering Corp. Kenilworth, NJ, by letters faxed and mailed on 7/2/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 738 bottles of 20 capsules
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: D-041-1, Premarin Tablets,(Conjugated Estrogen Tablets USP) 1.25 mg. Bottles of 5,000. New Lot numbers Codes: Lot 9010249, exp. Sept. 2003 Lot 9010403, exp. Sept. 2003 REASON: DISSOLUTION FAILURE MANUFACTURER/RECALLING FIRM: Ayerst Laboratories Rouses Point, NY RECALLED BY: Wyeth Ayerst Pharmaceuticals Richmond, VA, by letters sent August 8, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: AL, FL, NJ, NY, OH, TN, and TX QUANTITY: 2,070 bottles _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-298-1,TRAV-L-TABS (Meclizine HCl) 25 mg per tablet, 60 tablets per bottle
Codes: lots: 191002 Exp 9-01; 191111 Exp 10-01 REASON: PRODUCTION VALIDATION DEVIATION (Extended Holding Times for Powdered Ingredients) MANUFACTURER/RECALLING FIRM: Wendt Laboratories, Inc., Belle Plaine, MN RECALLED BY: Manufacturer, by letter dated July 20, 2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: ID, IL, NE, WI QUANTITY: 770 bottles
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1595-1, Red Blood Cells, Leukocytes Reduced, unit number 2210864 B-1596-1, Cryoprecipitated AHF, unit number 2210864 REASON: Blood products, corresponding to a unit of plasma possibly contaminated with Staphylococcus epidermidis bacteria, were distributed. MANUFACTURER/RECALLING FIRM: LifeShare, Inc., Elyria, OH RECALLED BY: Recalling Firm, by letter dated February 15, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: OH and MS QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1897-1, Red Blood Cells, (4 units), unit numbers 2104363, 2204393, 2140793, and 2206400 B-1898-1, Fresh Frozen Plasma, (2 units), unit numbers 2104363 and 2204393 REASON: Blood products, corresponding to units of Platelets which were pooled and possibly contaminated with coagulase negative Staphylococcus sp. bacteria, were distributed. MANUFACTURER/RECALLING FIRM: LifeShare, Inc., Elyria, OH RECALLED BY: Recalling firm, by letter dated February 15, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY: 6 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1903-1 Red Blood Cells, unit number 21GW18707; B-1904-1 Recovered Plasma, unit number 21GW18707 REASON: Blood products, collected from an unsuitable donor due to a history von Willebrand’s disease and medication with clotting factor concentrates, were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Pacific Northwest Region, Portland, RECALLED BY: Recalling Firm, by letters on July 18 and 26, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: WA and NY QUANTITY: 2 units
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1905-1, Platelets Pheresis, Leukocytes Reduced, unit number 10708-3157 REASON: Blood product, that was labeled leukoreduced but had an elevated white blood cell count, was distributed. MANUFACTURER/RECALLING FIRM: Blood Systems, Inc. Scottsdale, AZ RECALLED BY: Recalling Firm, by telephone on February 21, 2001 and letter dated March 19, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 1 unitRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1594-1,Platelets Pheresis, unit number LT12515 REASON: An investigational blood product was distributed and transfused to an individual that was not part of the clinical study. MANUFACTURER/RECALLING FIRM: Central Blood Bank, Pittsburgh, PA RECALLED BY: Institute for Transfusion Medicine Clinical Services, Pittsburgh, PA, by visit on August 22 and 23, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: PA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1899-1, Red Blood Cells, Leukocytes Reduced, unit numbers 15387-4761 and 15387-4762 REASON: Blood products, labeled with the incorrect expiration date, were distributed. MANUFACTURER/RECALLING FIRM: Blood Systems, Inc., Lubbock Center, Lubbock, TX RECALLED BY: Recalling Firm, by telephone on March 22, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Texas QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1900-1, Red Blood Cells, Irradiated, unit number 49FE03081; B-1901-1, Red Blood Cells, Leukocytes Reduced, Irradiated (9 units), unit numbers 49LL08111, 49LH46709, 49LQ13934, 49FJ77288, 49FJ77301, 49LG52436, 49GR30383, 49FF41676, and 49FF41683 REASON: Blood products, labeled with the incorrect expiration date, were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Southwest Region, Wichita Falls, TX RECALLED BY: Recalling Firm, by letter dated August 31, 2000 and follow-up letter on October 2, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 10 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1902-1, Platelets, unit number 4792509 REASON: Blood Product, labeled with the incorrect expiration date, was distributed. MANUFACTURER/RECALLING FIRM: Coffee Memorial Blood Center, Inc., Amarillo, TX. RECALLED BY: Recalling Firm, by letter dated June 5, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: One unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1906-1, Red Blood Cells, Leukocytes Reduced, unit number FM34636. REASON: Blood product, that was labeled as leukoreduced but failed quality control testing due to an elevated white blood cell count, was distributed. MANUFACTURER/RECALLING FIRM: /Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI RECALLED BY: Recalling Firm, by telephone on May 23, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: RI QUANTITY: 1 unitRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1041-1, Valleylab LigaSure vessel sealing system, CODES: Catalog Number: LS1000, Lot ANH000503. REASON: Previously recalled product, not released for distribution, was distributed. MANUFACTURER/RECALLING FIRM: Valleylab, Inc., Boulder, CO RECALLED BY: Recalling Firm, by letter dated 05/04/2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA, CO, and PA. QUANTITY: 18 units ______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1106-1 - Z-1108-1 Programmable Multi-Axis Controller (PMAC 2 Lite) circuit board installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Codes: a) Model 4380213 - E.CAM Gantry Single Head, serial numbers 0001 through 2016 b) Model 4380221 - E.CAM Gantry Dual Head, serial numbers 0005 through 2038, and 31827 c) Model 5242826 - E.CAM Gantry Dual Head,serial numbers 1001 through 2012 REASON: Resistor Packs installed backward causes software errors. MANUFACTURER/RECALLING FIRM: SIEMENS MEDICAL SYSTEMS, INC. HOFFMAN ESTATES, IL RECALLED BY: Recalling Firm, by visit on 12/4/98. No end user notifications were issued. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide and worldwide QUANTITY: 229 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1116-1/Z-1148-1 Various sterile surgical convenience kits and trays, including biopsy, pacemaker, and cardiac catheterization procedural trays manufactured and labeled by AVID Medical, Inc., identified by catalog, lot number and date of manufacture on each product, and containing vialed injectables: Ephedrine Sulfate 1 ml/50mg Heparin Sodium, 10 ml vial Heparin Injection 10 ml 1000 unit/ml Heparin Lock 10 ml, 100 u/ml Z Heparin Lock, 1 ml, 100 units Lidocaine, 1% 30 mL MDV Lidocaine, 50 mL 2% Vial M-Dose Lidocaine 30 ml 2% Vial Lidocaine, 30ml 1% VL Sng Dose Lidocaine, 2%hcl 20 ml Lidocaine, 50 ml 1% multidose Lidocaine, 20 ml 1% multidose Polocaine, 50 ml, 2% vial Sensorcaine, .5% w/EPI 30 ml Sodium Bicarbonate, 4%, 5ml VL Sodium Chloride, 30 ml .9% vial Sodium Chloride, 5cc vial Codes:CAT # Lot # Kit Description PLAS0001 #301893 Hair transplant AV011303-02 #307827 Needle Core Breast Biopsy AV011225 #306259,307312 Breast Pack SUBE0007-01 #308133 Angio SUBE0003 #308006 U.S/C.T. Biopsy FOHF0010-02 #307711,307832 Biopsy Myelogram FOHF0011-02 #307553,308271 Angio MGHM0002 #306109,306644 Biopsy NAVY001 #306554,307816 Cardiac Cath SUBE0002 #303596 Breast Biopsy AMBL0002 #307750 Vasectomy AMBL0004 #307597 Vasectomy SMHC0001 #307015,307658 Cardiac Cath STMH0001-01 #306586,307891 Angio MGHM0001 #307763 Angio SMHC0005-01 #308245 Suture Tray SMHC0004-01 #306815,307821 Angio MINN0005-04 #307559, Angio AC010928-01 #307275 E-P Tray AV010929 #308036 Pacemaker NAPO0035-01 #306481 AV Fistula NAPO0036-01 #306482,307489 Carotid Endart AV010913-01 #308024 Arthroscopy VMCC0001 #306904,307594 Cardiac Cath AV010767 #307051 Femoral AV010992-02 #307795 Angio TUCP0012-03 #307018 Neuro Angio TUCP0020-03 #307975 Angio TUCP0022-02 #307022,306475 Vascular PMCP0002 #307543,307818 Special Angio AV010892-01 #307394 Cardiac Cath HOUS0030-02 #304837 Heart tray MEDE0015 #307477 Cardiac Cath Each containing one or more of following lot numbers of injectables: VIAL INJECTABLE DESCRIPTION: ALL EXPIRY BETWEEN MAY 2001-SEP 2003 LIDOCAINE VIAL 30ML Lot 69-303-DK LIDOCAINE 20ML VIAL Lot 63-249-DK, 69-03-DK, 52-572-DK LIDOCAINE VIAL 30ML Lot 63-264-DK EPHEDRINE SULFATE 1ML LOT 50-218-DK-01 LIDOCAINE VIAL 30ML+ LOT 59-275-DK-01, 61-061-DK-01, 59-220- SODIUM BICARBONATE 5ML VL DK-01 SODIUM CHLORIDE VIAL 5CC LOT 9K003 SODIUM CHLORIDE VIAL 10CC LOT 66-394-DK SODIUM CHLORIDE VIAL 10CC LOT 67-021-DK SODIUM CHLORIDE VIAL 10CC LOT K150061 EPHEDRINE SULFATE 1ML LOT K150050 EPHEDRINE SULFATE 1ML LOT 46-349-DK EPHEDRINE SULFATE 1ML LOT 46-349-DK-01 EPHEDRINE SULFATE 1ML LOT 64-510-DK-01 HEP SODIUM 10ML VIAL LOT 089138, 66-394-DK LIDOCAINE VIAL 30ML LOT 65-364-DK HEP SODIUM 10ML VIAL LOT 089138, 66-394-DK LIDOCAINE 20ML VIAL+ LOT 50-298-DK, 58-691-DK, 58-465-DK SODIUM CHLORIDE 30ML VIAL LIDOCAINE 30ML VIAL LOT 040025 LIDOCAINE VIAL 30ML LOT 64-411-DK-01 LIDOCAINE 50ML VIAL LOT 65-290-DK-01 LIDOCAINE VIAL 30ML LOT 65-364-DK LIDOCAINE 50ML VIAL LOT 59-113-DK HEPARIN INJ 10ML VIAL LOT 030091 HEPARIN INJ 10ML VIAL LOT 030093 LIDOCAINE VIAL 30ML LOT 66-637-DK LIDOCAINE VIAL 30ML LOT 66-636-DK LIDOCAINE VIAL 30ML LOT 65186-DK01, 66636-DK01 LIDOCAINE 30ML 2% VIAL LOT 070128 LIDOCAINE VIAL 30ML LOT 66-636-DK-01, 64-568-DK-01 LIDOCAINE 50ML VIAL LOT 68-690-DK01, 68-690-DK02 LIDOCAINE VIAL 30ML LOT 65-061-DK, 65-364-DK LIDOCAINE 30ML 2% VIAL LOT 040150 LIDOCAINE VIAL 30ML LOT 66-636-DK,66-673-DK POLOCAINE 50ML VIAL+ LOT 001098,030119,119035 HEP LOCK 10ML SODIUM BICARBONATE 5ML VL LOT 67-129-DK-01 LIDOCAINE 20ML VIAL LOT 68-364-DK,61-046-DK,LOT 67-027-DK-01 LIDOCAINE 50ML VIAL LOT 69-201-DK01 LIDOCAINE 50ML VIAL LOT 66-506-DK SODIUM BICARBONATE 5ML VL+ LOT 67-129-DK-01 SODIUM CHLORIDE 10ML VIAL LOT 65-230-DK LIDOCAINE VIAL 30ML LOT 66-636-DK,68-567-DK LIDOCAINE 20ML VIAL LOT 69-233-DK-01 LIDOCAINE VIAL 30ML LOT 68-583-DK HEPARIN INJ 10ML VIAL LOT 080082 LIDOCAINE 50ML VIAL LOT 69-201-DK, 63-157-DK LIDOCAINE VIAL 30ML LOT 68-657-DK-01, 68-867-DK-01, 66-636-DK-01 LIDOCAINE 30ML 2% VIAL LOT 070128, 080184 LIDOCAINE 20ML VIAL+ LOT 69-048-DK SODIUM BICARBONATE 5ML VL LOT 67-129-DK LIDOCAINE 50ML VIAL LOT 68-690-DK-01, 69-203-DK-02 LIDOCAINE 20ML VIAL LOT 69-233-DK LIDOCAINE 20ML VIAL LOT 69-233-DK-01 LIDOCAINE 30ML 2% VIAL LOT 070128 LIDOCAINE 30ML 2% VIAL LOT 040150 LIDOCAINE VIAL 30ML LOT 69-303-DK, 68-583-DK HEPARIN LOCK 1ML LOT 050147 SENSORCAINE 30ML VIAL LOT 004031 LIDOCAINE 50ML VIAL LOT 68-690-DK SODIUM BICARBONATE 5ML VL LOT 69-258-DK-01,67-129-DK-01 LIDOCAINE VIAL 30ML LOT 69-303-DK SODIUM BICARBONATE 5ML VL+ LOT 61-044-DK-01 SODIUM CHLORIDE 10ML VIAL LIDOCAINE 50ML VIAL LOT 69-159-DK LIDOCAINE 50ML VIAL LOT 69-265-DK-01, LOT 69-338-DK-01 LIDOCAINE VIAL 30ML LOT 69-293-DK REASON: Stability and potency of kit injectable components cannot be assured after sterilization MANUFACTURER/RECALLING FIRM: Avid Medical, Inc., Toano, VA RECALLED BY: Recalling Firm, by letters on 1/24/2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 3408 kits and/or trays ______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1149-1,BVS 5000i Bi-Ventricular Support Console S/N's: 1599, 1601, 1602, 1609, 1611-1646 Codes: BVS 5000i Bi-Ventricular Support Console S/N's: 1599, 1601, 1602, 1609, 1611-1646 REASON: Leaking Compressor gaskets may cause low flow MANUFACTURER/RECALLING FIRM: Abiomed, Inc., Danvers, MA. RECALLED BY: Recalling Firm, by fax on 5/25/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide; Foreign: Australia, Netherlands, (Hospital Laval, Quebec) Canada, Spain, Mexico QUANTITY: 40 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1150-1 - Z-1151-1,CryoValve Allograft (Heart Valve) Codes: Model AV00 - Serial Number 3936694 Model PV00 - Serial Number 3936708 REASON: Does not meet current guidelines regarding serodilution of plasma. MANUFACTURER/RECALLING FIRM: CRYOLIFE, INC. KENNESAW, GA RECALLED BY: Recalling Firm by letters on 12/12/00 FIRM INITIATED RECALL: Complete DISTRIBUTION: NC and OK QUANTITY: 2 values _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1152-1 - Z-1153-1 Olympic Medical Vac Pac - primarily used to assist in maintaining patient position during surgery. Codes: Catalog #51630, size 30, serial #s 69862 through 70114 Catalog #51635, size 35, serial #s 69787 through 69830 REASON: Weak Seam Seal - Product not remaining firm as intended. MANUFACTURER/RECALLING FIRM: OLYMPIC MEDICAL CORP. SEATTLE, WA RECALLED BY: Recalling Firm, by letter on 6/14/01, follow-up fax on 7/9/01 and telephone on 7/16/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Canada, Ireland, Korea, New Zealand, Thailand, The Netherlands, United Kingdom and Germany QUANTITY: Catalog #51630 - 209; Catalog #51635 - 33 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1154-1, Roche/Hitachi Modular P Laboratory Clinical Chemistry Analyzer,Catalog No. 766-4019, All Serial Numbers; REASON: Incorrect results are obtained if the wash rack is placed on the instrument before placing the instrument in standby or stop mode. MANUFACTURER/RECALLING FIRM: Roche Diagnostics Corp., Indianapolis, IN RECALLED BY: Recalling Firm, by Product Correctionletter (Customer Bulletin) dated August 1, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 150 ________________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1170-1 - Z-1183-1 Intravenous Administration Sets for use with Gemstar infusion pumps. Z-1170-1: 13009-01 Latex-Free GemStar Pump Set-SL, Non-Vented, 110 " (w/ Yellow Striped Tubing) Z-1171-1: 13012-01 GemStar Pump Set with 0.2 Micron Filter, LIFESHIELD Prepierced Reseal Y Site, Non-Vented, 96 Inch- SL Z-1172-1: 13013-01 GemStar Nonphthalate Pump Set with 1.2 Micron, Filter, LIFESHIELD Prepierced Reseal Y Site Nonvented, 96"-SL Z-1173-1: 13014-01 GemStar Primary Pump Piggyback Set, with Convertible Piercing Pin, 110 inch with Backcheck Injection Site, Prepierced/Prepierced Y-Injection Site SL Z-1174-1: 13015-01 LifeShield Latex-Free GemStar Pump Set-SL, Nonvented, 96 inch (with Orange Polyethylene-lined resistant Tubing) Z-1175-1: 13016-01 Latex-Free GemStar I.V. Pump Set w/ PCA Extension-SL, Nonvented, 110 inch Z-1176-1: 13030-01 GemStar HEMA II Y-Type Blood Pump Set Z-1177-1: 13042-01 LifeShield Latex-Free Microdrip Soluset GemStar 150 mL Burette Pump Set - SL, Convertible Pin, 110 inch Z-1178-1: 13043-01 GemStar Primary Pump Set Z-1179-1: 13044-01 GemStar Pump I.V. Set Z-1180-1: 13046-01 Latex-Free GemStar Pump Set-SL, Nonvented, 96 inches Z-1181-1: 13242-01 LifeShield Latex-Free Microdrip Soluset GemStar 150 mL Burette Pump Set-OL, Convertible Pin, 110 inch with 3 Clave Ports Z-1182-1: 13243-01 LifeShield Latex-Free GemStar Piggyback Pump Set- OL, Convertible Pin, 110 inch with 0.2 Micron Filter and 3 Claves Z-1183-1: 13245-01 LifeShield Latex-Free GemStar Primary Piggyback Pump Set - OL, Convertible Pin, 110 inch with 2 Claves Codes: List No. 13009-01 Lots 45307HG, 70011HG, 75084HG, 77070HG, 78090HG List No. 13012-01 Lots 79099HG, 75105HG, 73141HG, 70136HG, 68165HG, 45295HG List No. 13013-01 Lots 76068HG, 75088HG, 73151HG, 70224HG, 68144HG, 46256HG List No. 13014-01 Lots 68148HG, 60303HG, 47205HG, 43289HG, 75094HG List No. 13015-01 Lots 69172HG, 48246HG, 74076HG List No. 13016-01 Lots 45308HG, 77158HG List No. 13030-01 Lots 63127HG, 70268HG, 75061HG List No. 13042-01 Lots 70107HG, 63107HG List No. 13043-01 Lots 68247HG, 74070HG, 78120HG List No. 13044-01 Lots 70226HG, 68229HG List No. 13242-01 Lot 76211HG List No. 13243-01 Lot 77262HG List No. 13245-01 Lots 78233HG, 77263HG List No. 13046-01 Lots 75108HG, 76140HG, 73146HG, 70204HG, 71117HG, 53128HG, 50352HG, 67212HG REASON: Sets over infuse with user error during setup MANUFACTURER/RECALLING FIRM: Abbott Laboratories, Inc. Laurinburg, NC RECALLED BY: Abbott Laboratories, Inc. San Diego, CA, by letter dated July 30, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and to United Kingdom, France, Canada, Australia QUANTITY: 89,468 ________________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1184-1 - Z-1185-1 AxSYM Troponin-I; a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I in human serum or plasma on the AxSYM System. Troponin-I values are used to assist in the diagnosis of acute myocardial infarction (AMI). Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Codes: Reagent Lots - list 3C29-20; lots 69644M300, 69644M301, 70246M300, 70246M301, 70974M300, 70974M301, 71096M200, 71096M201, 71112M200, 71112M201, 71113M200, 71113M201, 71115M200, 71115M201, 71214M100, 71214M101, 71215M100, 71215M101 Calibrator Lots - list 3C29-01: Lots 70525M100, 70525M101, 70525M102 REASON: Falsely high results MANUFACTURER/RECALLING FIRM: Abbott Laboratories, Inc. Abbott Park, IL RECALLED BY: Recalling Firm, by letters dated 2/20/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, and International QUANTITY: 35523 -reagent, 3241 -calibrator
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1115-1 Disposable Glass Tip (P/N 10,010,142), a single use component used with Dermabrader DMS1000 handpiece, for scar revision and tattoo removal. Instrument is classified as a Dermatome, class I device. Disposable tips packaged in cartons, 24 pieces/carton. Codes: Lots 637, 691, 11, and 39 REASON: Burr on plastic tip of dermabrasion instrument could cause injury to skin. MANUFACTURER/RECALLING FIRM: Mattioli Engineering Corporation, SRA, Firenze Italy. RECALLED BY: Mattioli Engineering Corporation, Arlington, VA, issued e-mails on 4/3/2001 and 5/7/2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA, SC, FL, NY, TX, and CO, and Canada QUANTITY: 3032 pieces ______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1155-1 Steris Quick Connect, Model C1665, is designed to process the Olympus 20D Series and BF-XT20 Bronchoscopes in STERIS SYSTEM I Sterile Processing System, with C1160 Universal Processing Tray. Codes: Lot Number: CA22900. Catalogue Number: #QC 1665. REASON: The tubing in the kits are labeled with an incorrect endoscope model number. MANUFACTURER/RECALLING FIRM: STERIS CORP. MENTOR, OH RECALLED BY: Recalling Firm, by telephone on 9/15/2000 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: GA QUANTITY: 2 units
END OF ENFORCEMENT REPORT FOR SEPTEMBER 19, 2001 ####
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