August 28, 2002 02-34
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
_______________________ PRODUCT a) Air, Compressed (Medical Air,USP) UN1002, Black H size cylinders. Recall # D-390-2; b) Carbon Dioxide, USP, UN1013, Black H size cylinders. Recall # D-391-2. CODE Lot #QH02P135A, Exp. 05-07 #QH02P136A, Exp. 05-07 #QH02P136B, Exp. 05-07 #QH02P136C, Exp. 05-07. RECALLING FIRM/MANUFACTURER Recalling Firm: Puritan Medical Products, Inc., Overland Park, KS, by telephone and visit on May 23, 2002. Firm initiated recall is complete. REASON Mislabeling: Nitrogen NF cylinders mislabeled as Medical Air USP or Carbon Dioxide USP. VOLUME OF PRODUCT IN COMMERCE 111 size H cylinders. DISTRIBUTION FL.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT a) Therevac®-SB Mini Enema (Docusate Sodium 283 mg) Gelatin Ampules, unit doses of 5 and 30 and bottles of 10 and 30. Recall # D-386-2; b) Therevac-Plus Mini Enema w/Anesthetic, (Docusate Sodium 283 mg, Benzocaine 20 mg) Gelatin Ampules, unit doses of 5 and 30 and bottles of 50. Recall # D-387-2. CODE Therevac-SB NDC Package Lot Number (Expiration) 52604-8317-00 1 X 5 Unit Dose K09002 (08/02), K11001 (09/02), M02001 (12/02) 52604-8317-09 6 X 5 Unit Dose K09002 (08/02), K11001 (09.02), M02001 (12/02), M06001 (04/03) 52604-8317-02 10 ct bottles K09001 (08/02), K09002 (08/02), K11001 (09/02), K12001 (11/02), K12002 (11/02), M06001 (04/03) 52604-8317-03 30 ct bottles K09001 (08/02), K09002 (08/02), K11001 (09/02), K12001 (11/02), K12002 (11/02), M01002 (11/02), M02001 (12/02), M02002 (01/03), M06001 (04/03) Therevac-Plus NDC Package Lot Number/Expiration 52604-8315-00 1 X 5 Unit Dose M01001 (12/02) 52604-8315-09 6 X 5 Unit Dose K10001 (08/02), M01001 (12/02), M06002 (05/03), M10002 (09/03) 52604-8315-05 50 ct bottles K10001 (08/02), M01001 (12/02), M01003 (11/03), M06002 (05/03). RECALLING FIRM/MANUFACTURER Recalling Firm: King Pharmaceuticals, Inc., Bristol, TN, by letter on July 31, 2002. Manufacturer: R. P. Scherer Laboratories, St. Petersburg, FL. Firm initiated recall is ongoing. REASON Stability; product may not meet specifications throughout the labeled expiration date. VOLUME OF PRODUCT IN COMMERCE 102,807. DISTRIBUTION Nationwide. _______________________ PRODUCT GOJO Skin Lotion Medicated (Allantoin 0.7%), 5 fl oz tubes NET 148 mL. Recall # D-388-2. The catalog numbers and packaging configuration are as follows: #8140-24 (case of 24); #8140-24-B5P00 (case of 24); #8140-06-BH200 (case of 6); #8140-12-BYR00 (case of 12) CODE LOT NUMBERS: 134239, 138256, 147523, 151914, 152499, 153752, 160436, 169565, 170833. RECALLING FIRM/MANUFACTURER GOJO Industries, Inc., Cuyahoga Falls, OH, by fax on July 25, 2002. Firm initiated recall is ongoing. REASON Subpotent; active ingredient Allantoin (stability). VOLUME OF PRODUCT IN COMMERCE 12,719 cases. DISTRIBUTION Nationwide. _______________________ PRODUCT Metformin HCl Drug Substance. Recall # D-389-2. Strength (Purity:) HPLC: 98.0 -102.0% Size: 50 kg Form: Crystalline Powder Route of Administration: will eventually be used for oral dosage form Rx, uses/application: Diabetes Type II This is a bulk pharmaceutical drug CODE Lot no. Re-evaluation date 212001MF1 Feb 2005 212101MF1 Feb 2005 212201MF1 Feb 2005. RECALLING FIRM/MANUFACTURER ChemSource Corporation Guayama, Puerto Rico, by verbal notification March 27, 2002. Firm initiated recall is complete. REASON Potential cross contamination. VOLUME OF PRODUCT IN COMMERCE 905.2 kg, 1,157.1 kg, 1,164.0 kg. DISTRIBUTION Nationwide. ______________________ PRODUCT Proventil® brand of (albuterol sulfate, USP) Repetabs® brand of extended- release Tablets, 4 mg, unit dose of 100, bottles of 100 and 500, Rx only, Recall # D-392-2; Theo-Dur® (theophylline (anhydrous)) extended-release Tablets 200 mg, unit dose of 100, bottles of 100, 500, 1000 and 5000, Rx only, Recall # D-393-2; Also sold as: THEOPHYLLINE (Anhydrous) Extended-Release Tablets, 200 mg, bottles of 100, 500 and 1000, Rx only, Theo-Dur® (theophylline (anhydrous)) extended-release tablet, 300 mg, unit dose of 100, bottles of 100, 500, 1000 and 5000, Recall # D-394-2; Also sold as: THEOPHYLLINE (Anhydrous) Extended-Release Tablets, 300 mg, bottles of 100, 500 and 1000, Rx only, Theo-Dur® (theophylline (anhydrous)) extended-release tablet, 450 mg, unit dose of 100, bottles of 100, Rx only, Recall # D-395-2; Also sold as: THEOPHYLLINE (Anhydrous) Extended-Release Tablets, 450 mg, bottles of 100, Rx only Uni-Dur® (theophylline) Extended-release Tablets, 600 mg, bottles of 100, Rx only, Recall # D-396-2. CODE Schering Proventil® Repetabs® brand of albuterol sulfate, USP extended release tablets: Lot Number Expiration Date Lot Number Expiration Date 0-RDR-89 November 2002 0-RDR-2014 June 2002 0-RDR-2005 April 2002 0-RDR-58 July 2002 0-RDR-2009 May 2002 1-RDR-2001 July 2002 0-RDR-2013 June 2002 1-RDR-2004 July 2002 0-RDR-72 July 2002 1-RDR-2004 November 2002 0-RDR-2004 April 2002 1-RDR-2000 July 2002 0-RDR-2006 April 2002 1-RDR-2002 July 2002 0-RDR-2008 May 2002 1-RDR-2003 July 2002 0-RDR-2010 May 2002 1-RDR-2005 November 2002 0-RDR-2011 April 2002 1-RDR-2006 July 2002 0-RDR-2012 May 2002 1-RDR-2007 November 2002 Schering Theo-Dur® brand of theophylline, USP: Lot Number Expiration Date Lot Number Expiration Date 0-KHP-439 (200mg) April 2002 0-FCY-396 (300mg) April 2002 0-KHP-440 (200mg) April 2002 0-FCY-521 (300mg) April 2002 0-KHP-515 (200mg) May 2002 0-FCY-673 (300mg) August 2002 0-KHP-581 (200mg) July 2002 0-FCY-497 (300mg) April 2002 0-KHP-395 (200mg) April 2002 0-FCY-674 (300mg) August 2002 0-KHP-524 (200mg) June 2002 1-FCY-049 (300mg) November 2002 0-KHP-675 (200mg) August 2002 0-PXG-526 (300mg) August 2002 0-KHP-462 (200mg) May 2002 0-PXG-735 (300mg) October 2002 0-KHP-736 (200mg) August 2002 0-PXG-746 (300mg) April 2002 0-FCY-379 (300mg) April 2002 Warrick Theophylline tablets, USP: Lot Number Expiration Date Lot Number Expiration Date 0-PHN-415 (200mg) April 2002 0-CGE-520 (300mg) June 2002 0-PHN-599 (200mg) August 2002 0-CGE-582 (300mg) August 2002 0-PHN-464 (200mg) May 2002 0-CGE-453 (300mg) May 2002 0-PHN-522 (200mg) May 2002 0-GNB-371 (450mg) May 2002 0-PHN-404 (200mg) April 2002 0-GNB-449 (450mg) August 2002 0-CGE-512 (300mg) May 2002 0-GNB-600 (450mg) August 2002 1-CGE-037 (300mg) August 2002 0-GNB-703 (450mg) August 2002 0-CGE-463 (300mg) May 2002 Schering Uni-Dur® brand of theophylline, USP: Lot Number Expiration Date 0-HKH-719 (600mg) June 2002. RECALLING FIRM/MANUFACTURER Schering Corp., Kenilworth, NJ, by letters dated May 6, 2002. Firm initiated recall is ongoing. REASON Dissolution; failures at the sixth and eighth hour (stability). VOLUME OF PRODUCT IN COMMERCE Proventil Repetabs: 205,591; Theo-Dur: 191,505; Uni-Dur: 7,304, Warrick Theophylline: 616,795. DISTRIBUTION Nationwide and Puerto Rico. _______________________ PRODUCT a) Proventil brand of (albuterol sulfate, USP) Repetabs brand of extended-release Tablets, 4 mg, bottles of 100, Rx only. Recall # D-330-2; b) Theo-Dur (THEOPHYLLINE(Anhydrous), Extended-Release Tablets 200 mg, bottles of 100 and 500, Rx only. Recall # D-331-2. CODE a) PROVENTIL Lot Number Exp Date 15920 APR 02 16224 APR 02 16678 MAY 02 16745 MAY 02 010804 JUL 02 b) THEO-DUR Lot Number Exp Date 16924 MAY 02 16228B MAY 02 16228A MAY 02 16411 MAY 02 RECALLING FIRM/MANUFACTURER Recalling Firm: AmeriSource Health Services Corp., Columbus, OH, by letter and fax on June 4, 2002. Manufacturer: Schering Corp., Kenilworth, NJ. Firm initiated recall is ongoing. REASON Dissolution; failures at the sixth and eighth hour (stability) by manufacturer. VOLUME OF PRODUCT IN COMMERCE 8,406 bottles (Proventil); and 3,318 bottles (Theo-Dur). DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT a) Red Blood Cells, Recall # B-1805-2; b) Recovered Plasma, Recall # B-1806-2. CODE a) and b) Unit P13436. RECALLING FIRM/MANUFACTURER Delta Blood Bank, Stockton, CA, by letter dated June 21, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who had been diagnosed with Multiple Sclerosis, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1815-2. CODE Units 12FZ03927, 12FZ03929, 12FZ03934, 12FZ03949, 12FZ03969. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Carolinas Region, Charlotte, NC, by telephone on January 9, 2002 and by letter dated January 30, 2002. Firm initiated recall is complete. REASON Blood products, which had a questionable weight, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION NC. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1817-2. CODE Unit S16909. RECALLING FIRM/MANUFACTURER Delta Blood Bank, Stockton, CA, by letter dated November 16, 2000. Firm initiated recall is complete. REASON Blood product, which was inadequately irradiated, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1822-2; b) Recovered Plasma, Recall # B-1823-2. CODE a) and b) Unit number Q04198. RECALLING FIRM/MANUFACTURER Delta Blood Bank, Stockton, CA, by telephone on August 29, 2001. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor due to a history of residing in the United Kingdom for more than 3 months, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA and NY. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-1824-2. CODE Unit numbers 42KF07305 and 42KF07481 (both units distributed as two split units). RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH, by letter dated June 4, 2002. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor due to a history of residing in the United Kingdom for more than 3 months, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION OH. _______________________ PRODUCT Platelets Pheresis, Recall # B-1826-2. CODE Unit number 24FH29133. RECALLING FIRM/MANUFACTURER The American National Red Cross, River Valley Region, Louisville, KY, by letter dated May 20, 2002. Firm initiated recall is complete. REASON Platelets Pheresis with an elevated platelet count based on volume of product collected were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION KY. _______________________ PRODUCT a) Platelets Pheresis, Leukocytes Reduced, Recall # B-1827-2; b) Platelets Pheresis, Leukocytes Reduced Irradiated, Recall # B-1828-2. CODE a) Unit numbers 03P33832, 03P33697, 03P33740, 03P33775, and 03P33819; the following units were distributed as two split units: unit numbers 03P33683, 03P33710, and 03P33832 b) Unit number 03P33697. RECALLING FIRM/MANUFACTURER The American National Red Cross, Southern Region, Atlanta, GA, by letter on August 31, 2001. Firm initiated recall is complete. REASON Blood products, that were labeled leukoreduced but were manufactured using apheresis equipment that experienced failures resulting in products with an elevated white blood cell count, were distributed. VOLUME OF PRODUCT IN COMMERCE 11 units. DISTRIBUTION GA. _______________________ PRODUCT Counterfeit Epogen? (Epoetin alfa), labeled as 40000 unit/ml vials, 10 vials/box, Recall # B-1830-2. CODE Lot number P002970. RECALLING FIRM/MANUFACTURER Grapevine Trading Company, dba Drogueria Central, Inc., Springboro, OH, by telephone, fax and letter on May 15 and 28, 2002. Firm initiated recall is ongoing. REASON Counterfeit drug product, with a concentration of active ingredient less than labeled, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 lot. DISTRIBUTION KY, NJ, CA, AZ, FL, IN and TX. _______________________ PRODUCT Counterfeit Epogen? (Epoetin alfa), labeled as 40000 unit/ml vials, 10 vials/box, Recall # B-1831-2. CODE Lot number P002970. RECALLING FIRM/MANUFACTURER The F. Dohmen Company, Germantown, WI, by letter between May 10 and 17, 2002 and by telephone on May 31, 2002. Firm initiated recall is ongoing. REASON Counterfeit drug product, with a concentration of active ingredient less than labeled, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 lot. DISTRIBUTION WI and MI. _______________________ PRODUCT a) Red Blood Cells Leukocytes Removed, Recall # B-1862-2; b) Cryoprecipitated AHF, Recall # B-1863-2; c) Platelets for Further Manufacture, Recall # B-1864-2; d) Recovered Plasma, Recall # B-1865-2. CODE a) and d) Units 1750606 and 1692087; b) Unit 4013495; c) Unit 1692087. RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by telephone and fax on April 6, 19 or May 23, 2001. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who was previously deferred for engaging in high-risk behavior, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION FL, WI, CA and TX.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1825-2. CODE Unit number E46470. RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by letter dated June 13, 2002. Firm initiated recall is complete. REASON Blood product that was possibly out of controlled storage for more than 30 minutes was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IL. _______________________ PRODUCT Pyrotell? Limulus Amebocyte Lysate assay in single test vials, Recall # B-1829-2. CODE Lot numbers S99-089, S00-134, S00-136, S00-145, S00-148, S00-153, and S01-173. RECALLING FIRM/MANUFACTURER Associates of Cape Cod, Inc., Falmouth, MA, by letter dated July 1, 2002. Firm initiated recall is complete. REASON Limulus Amebocyte Lysate (LAL) test kits that may exhibit a decreased potency were distributed. VOLUME OF PRODUCT IN COMMERCE 7 lots. DISTRIBUTION Nationwide and Internationally.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________ PRODUCT CryoValve Heart Valve Allograft. Recall # Z-1239-2. CODE Serial No. 7746517, Model No. AV00. RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA, by letter on May 30, 2002. Firm initiated recall is complete. REASON Findings of transitional cell cancer in donors bladder. VOLUME OF PRODUCT IN COMMERCE 1 valve. DISTRIBUTION PA. _______________________ PRODUCT Bio-Rad brand MICROMAT II HEMOGLOBIN HbA1c Test Cartridge (for use in MICROMAT II HEMOGLOBIN HbA1c Test Instrument) Catalog No. 280-0008. Recall # Z-1240-2. CODE Catalog No.: 280-0008 Lot #: Exp. Dates: 050K28 5/29/02 050K29 6/1/02 050K31 7/13/02 050K32 7/13/02 050K33 7/23/02 050K34 8/2/02 050K35 8/10/02 050K36 8/30/02 050K37 9/19/02 050K38 10/1/02 050K39 10/5/02. RECALLING FIRM/MANUFACTURER Recalling Firm: Bio-Rad Laboratories, Inc., Hercules, CA, by Telephone and facsimile on June 13, 2002. Manufacturer: Provalis Diagnostics, New Tech Square, Deeside, Flintshire CH5 2NT, United Kingdom. Firm initiated recall is ongoing. REASON Product stored at temperatures outside manufacturer’s specifications. VOLUME OF PRODUCT IN COMMERCE Total of 4119 affected lots were distributed. Lot # 050K28: 402, Lot #050K29: 158,Lot #050K31: 193, Lot #050K32: 15, Lot #050K33: 103, Lot #050K34: 559, Lot #050K35: 167, Lot #050K36: 851, Lot #050K37: 90, Lot #050K38: 864, Lot #050K39: 717. DISTRIBUTION Nationwide. _______________________ PRODUCT TransFx Bar to Bar Clamp (or Rod to Rod Clamp), 11mm. Recall # Z-1241-2. CODE Catalog (Part) No.00-4452-010-11 Lot No’s: 70189400, 70193300, 70197800, and 70200400. RECALLING FIRM/MANUFACTURER Immedica, Inc., Chatham, NJ, by letter dated March 20, 2002. Firm initiated recall is ongoing. REASON Product failure due to broken screw. VOLUME OF PRODUCT IN COMMERCE 604 Units. DISTRIBUTION IN. _______________________ PRODUCT Acuson brand Aspen® Diagnostic Ultrasound System with various versions of software. Recall # Z-1247-2/Z-1250-2. CODE Catalog No: 8247888, 8261531, 8247887, 8253683. The transducers which are the subject of this action are as follows: 13L5; 4C1; 4V2c; C3; C7; EC7; EV7; EVC8; L582; V4c; V5; V7 RECALLING FIRM/MANUFACTURER Acuson Corp., Mountain View, CA, by letter June 14, 2002. Firm initiated recall is ongoing. REASON Certain components of the system (transducers) have the potential to reach a temperature which is above the allowable limit. VOLUME OF PRODUCT IN COMMERCE Approx. 3500. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Acuson Sequoia® Diagnostic Ultrasound System with various versions of software. Recall # Z-1251-2/Z-1252-2. CODE Catlog No: 8246951 (Model C256); Catlog No: 8245876 (Model 512). RECALLING FIRM/MANUFACTURER Acuson Corp., Mountain View, CA, by letter June 14, 2002. Firm initiated recall is ongoing. REASON Transducers have the potential to reach a temperature above the allowable limit. VOLUME OF PRODUCT IN COMMERCE 6650. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT a) Stryker Bertec Acute Care Bed Model 3000, half length side rails, 80" electric AC powered adjustable bed, model series FL13E80, U.S. order number 32501000000. Recall # Z-1254-2; b) Stryker Bertec Acute Care Bed Model 3000, half length side rails, 84" electric AC powered adjustable bed, model series c) Stryker Bertec Acute Care Bed 3000, half length side rails, 72" manual adjustable hospital bed, model series FL13M72, U.S. order number 32503000000. Recall # Z-1256-2; d) Stryker Bertec Acute Care Bed Model 3000, half length side rails, 78" manual adjustable hospital bed, model series FL13M78, U.S. order number 9999999305. Recall # Z-1257-2; e) Stryker Bertec Acute Care Bed Model 3000, half length side rails, 84" manual adjustable hospital bed, model series FL13M84, U.S. order number 32504000000. Recall # Z-1258-2. CODE Serial numbers A71194 through A78105. RECALLING FIRM/MANUFACTURER Recalling Firm: Stryker Corp., Stryker Medical Division Kalamazoo, MI, by letter dated June 20, 2002. Manufacturer: Styker Bertec Medical Inc., L'Islet (Quebec), Canada. Firm initiated recall is ongoing. REASON Side rails may unlock and drop. VOLUME OF PRODUCT IN COMMERCE 442. DISTRIBUTION Nationwide and Puerto Rico. _______________________ PRODUCT a) Centurion brand 1.45 cm circ. bells & inserts, sterile, single use. Product CR145. Recall # Z-1259-2; b) Centurion brand CIRCLAMP with 1.45 cm bell & insert, latex free, sterile. Product CR245. Recall # Z-1260-2; c) Centurion brand CHS circumcision tray with 1.45 clamp, sterile. Product CIT2940. Recall # Z-1261-2; d) Centurion brand circumcision tray with 1.45 clamp, latex-free, sterile. Product CIT3370. Recall # Z-1262-2. CODE a) lots 02252, 11121 and 03051; b) lots 05132, 03252, 03182, 02182, 10151, 09101, 08131, 04301, 06111, 07091, 04231, 04271 and 03191; c) lot 510011; d) lots 512171, 502042, 502252, 503252 and 504222. RECALLING FIRM/MANUFACTURER Tri-State Hospital Supply Corp., Howell, MI, by letter beginning June 28, 2002. Firm initiated recall is ongoing. REASON Clamping procedure may fail due to cracks in the bell. VOLUME OF PRODUCT IN COMMERCE 2,006. DISTRIBUTION Nationwide. _______________________ PRODUCT Deflectable Circular Mapping Lasso Catheter. Recall # Z-1263-2. CODE Device product code: D7-L10-12-RT Part Number: D-1220-05-S All lots. RECALLING FIRM/MANUFACTURER Biosense Webster, Inc., Irwindale, CA, by letter on June 21, 2002. Firm initiated recall is ongoing. REASON Perforation on soft tip of the LASSO catheter. VOLUME OF PRODUCT IN COMMERCE Not specified. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT In Line NebTee with Valve Aerosol Tee Connector. Recall # Z-1264-2. CODE Lot numbers 20021 and 21021. RECALLING FIRM/MANUFACTURER Hudson Respiratory Care, Inc., Temecula, CA, by letter on or before January 3, 2002. Firm initiated recall is ongoing. REASON Assembly defect. VOLUME OF PRODUCT IN COMMERCE 879 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Medusa software, DiaSorin Part 15794, for an OMNI (automated microtiter plate) Instrument used for the ETI-HA-IGMK Plus Enzyme Immunoasay for the Detection of IgM Antibody to Hepatitis A Virus in Human Serum or Plasma. Recall # Z-1265-2. CODE Medusa software, DiaSorin Part 15794. RECALLING FIRM/MANUFACTURER Diasorin Inc., Stillwater, MN, by telephone on June 11 and 12, 2002. Firm initiated recall is ongoing. REASON As a result of a software error, the cut-off for the ETI-HA-IGMK Plus kit would be incorrectly calculated, potentially causing false negative results to be reported. VOLUME OF PRODUCT IN COMMERCE Six laboratories had the defective software. DISTRIBUTION FL, KS, NY and TX. _______________________ PRODUCT CLARION brand Cochlear Implant Guide. Recall # Z-1266-2. CODE All product codes. RECALLING FIRM/MANUFACTURER Advanced Bionics Corp., Sylmar, CA, by letter on June 27 and 28, 2002. Firm initiated 24 hour alert. REASON Firm is recalling due to association of implant guide with meningitis cases. VOLUME OF PRODUCT IN COMMERCE Not disclosed. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Model 500A Hyperbaric Ventilator. Recall # Z-1267-2. CODE Serial numbers: 270, 493, 400, 9, 527, 570, 75, 227, 495, 563, 160, 215, 126, 121, 10, 507, 25, 218, 101, 230, 104, 80, 481, 145, 87, 132, 286, 567, 62, 91, 512, 479, 271, 118, 119, 97, 86, 421, 194, 211, 298, 548, 549, 551, 552, 553, 554, 555, 556, 557, 558, 559, 560, 561, 562, 564, 566, 550, 565. RECALLING FIRM/MANUFACTURER Sechrist Industries, Inc., Anaheim, CA, by letter dated July 8, 2002. Firm initiated recall is ongoing. REASON Complaint of malfunction of hyperbaric ventilator. VOLUME OF PRODUCT IN COMMERCE 59. DISTRIBUTION Nationwide, Austrialia, Brazil, Japan and Taiwan. _______________________ PRODUCT Accu Chek Inform blood glucose monitoring system. Recall # Z-1268-2. CODE All units that have ever displayed a temperature icon in conjunction with patient use. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corporation, Indianapolis, IN, by visit on August 2, 2002. Manufacturer: 0 Roche Diagnostics, Mannheim, Germany. Firm initiated recall is ongoing. REASON May give erroneous results if the temperature icon has ever been displayed with use. VOLUME OF PRODUCT IN COMMERCE 15,452. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________ PRODUCT Spectro Ferritin MT Substrate reagent for Spectro Ferritin MT assay. Recall # Z-1234-2. CODE Substrate code of 210081. RECALLING FIRM/MANUFACTURER Ramco Laboratories, Inc., Houston, TX, by letters and telephone on November 15 and 28, 2001. Firm initiated recall is complete. REASON Calibrating reagents may degrade and cause the calibration curve to become skewed. VOLUME OF PRODUCT IN COMMERCE 35 kits. DISTRIBUTION NY, IA, MI, NJ, PA and Switzerland. _______________________ PRODUCT Choice A.B. (aberrtion blocking) Daily Wear Soft (hydrophilic) Contact Lens. The product is packaged in multipacks. Recall # Z-1235-2. CODE Lot 0313 and 0905. RECALLING FIRM/MANUFACTURER Recalling Firm: Ciba Vision Corp., Duluth, GA, by letter on May 24, 2002. Manufacturer: Specialty Ultravision, St. Hubert, Quebec, Canada. Firm initiated recall is ongoing. REASON Labeling problem. VOLUME OF PRODUCT IN COMMERCE 50 units. DISTRIBUTION CA, MA, MO, OR and Canada. _______________________ PRODUCT a) Kallestad HEp-2 12 well slides. Recall # Z-1236-2; b) Kallestad HEp-2 12 well, 60 Test Kit. Recall # Z-1237-2; c) Kallestad HEp-2 12 well, 240 Test Kit. Recall # Z-1238-2. CODE a) Catalog #30470, Lot #910927 and 910929; b) Catalog #30471, Lot #908855; c) Catalog #30472, Lot #911821. RECALLING FIRM/MANUFACTURER Bio-Rad Laboratories, Redmond, WA, by letter dated September 7, 2001. Firm initiated recall is complete. REASON Reactivity issues may cause low titered positive samples to not be detected. VOLUME OF PRODUCT IN COMMERCE a) Lot #910927 - 2989, lot #910929 – 13380; b) Lot #908855 – 190; c) Lot #911821 - 499. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT a) Architect Prolactin Calibrator Kit, list number 6C27-01, 2 - 4 mL bottles of calibrators per box. Recall # Z-1245-2; b) Architect Prolactin Control Kit, list number 6C27-10, 3 - 8 mL bottles of controls per box. Recall # Z-1246-2. CODE a) lots 76916M300 and 84229M100; b) lot 76926M300. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Abbott Park, IL, by letter dated June 11, 2002. Firm initiated recall is ongoing. REASON The concentration of prolactin decreased by 20%. VOLUME OF PRODUCT IN COMMERCE 1512 kits. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Abbott Bilirubin Calibrator Cat No 01E66-01. Recall # Z-1253-2. CODE Lot 79131M200. RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Laboratories, Inc., South Pasadena, CA, by letter on June 25, 2002. Manufacturer: Medical Analysis Systems, Inc., Camarillo, CA. Firm initiated recall is ongoing. REASON Calibration set values misprinted on labeling, affects neonatal values. VOLUME OF PRODUCT IN COMMERCE 426. DISTRIBUTION Nationwide and Internationally.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
_______________________ PRODUCT Bactoderm(mupirocin) 2% ointment packaged in 15 grams tube. Recall # V- 156-2. CODE Lot no. 32-1BH25 Exp. date 9/30/02. RECALLING FIRM/MANUFACTURER SB Pharmco Puerto Rico, Inc., Cidra, Puerto Rico, by telephone and letter April 15, 2002. Firm initiated recall is ongoing. REASON Presence of Pseudomona flourescens. VOLUME OF PRODUCT IN COMMERCE 46,128 units. DISTRIBUTION PA. _______________________ PRODUCT The following custom mixed animal feeds are recalled --- a) [non-ruminant]: Horse Feed, Hog Feed, and 14% Pig Feed. Recall # V-157-2; b) [ruminant]: Dairy Feed, Steer Feed, New Goat Feed, Cattle Feed, and Beef Feed. Recall # V-158-2. CODE The product is coded only with the manufacturing date and invoice numbers. All feed products manufactured and shipped since July 9, 2001 are affected by this recall. RECALLING FIRM/MANUFACTURER Recalling Firm: Shepard Grain Company, Inc., Urbana, OH, by telephone on January 11, 2002. Manufacturer: Shepard Grain Company, Inc., W. Liberty, OH. FDA initiated recall is complete. REASON Ruminant and non-ruminant animal feeds contain BSE prohibited material, and are either misbranded or adulterated. VOLUME OF PRODUCT IN COMMERCE 41,129 LBS (20.5 toms). DISTRIBUTION OH.END OF ENFORCEMENT REPORT FOR AUGUST 28, 2002
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