August 27, 1997 97-35 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============ _______________ PRODUCT The Sandwich Makers Sandwiches: a) Steak & Cheese Sub, 7 ounces; b) Ham & Cheese Sub, 7.5 ounces; c) Submarine, 8 ounces. Recall #F-681/683-7. CODE 7161. All products have a 7 day self life. MANUFACTURER Americas Foods, Inc., Norfolk, Virginia. RECALLED BY Manufacturer, by fax on June 24, 1997. Firm-initiated recall complete. DISTRIBUTION a) Arizona, Texas, South Carolina, Illinois, Mississippi, Kentucky, Florida b&c) Virginia, North Carolina, South Carolina. QUANTITY a) 1,230 sandwiches; b) 332 sandwiches; c) 260 sandwiches were distributed. REASON Products are contaminated with Listeria monocytogenes. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Bluebird Pineapple Juice from concentrate, in 6 ounce tin cans. Recall #F-680-7. CODE EHEAT. MANUFACTURER Citrus World, Inc., Lake Wales, Florida. RECALLED BY Manufacturer, by telephone beginning on April 17, 1997, followed by press release on April 23, 1997, and letter dated April 22, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 35,924 cases REASON Product contains high levels of tin. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ========== _______________ PRODUCT Sea-Clens Wound Cleanser, (Sodium Chloride), in 6 fluid ounce bottles. (Note: The product is labeled with the company name of Sween Corporation, N. Mankato, Minnesota.) Recall #D-249-7. CODE Lot #1G6AB EXP 7/98. MANUFACTURER Coloplast Corporation, North Mankato, Minnesota. RECALLED BY Manufacturer, by letter on August 12, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 740 cases (6 bottles per case) were distributed; firm estimated that 10 percent of product remained on market at time of recall initiated. REASON Pseudomonas Aeruginosa contamination. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ========== _______________ PRODUCT ACTH (Corticotropin for Injection, USP), 40 units, in 10 ml vials. Rx, a preparation of pituitary adrenocorticotropin hormone derived from the anterior lob of hog pituitary. Recall #D-248-7. CODE Lot numbers: 01156P, EXP 8/97; 01256P, EXP 9/97; and 01356P, EXP 9/97. MANUFACTURER Warner-Lambert Company, Parke-Davis Sterile Products Division, Rochester, Michigan. RECALLED BY The Parke-Davis Division of Warner-Lambert Co., Morris Plains, New Jersey, by letter on July 28, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY The amount of product shipped was as follows: 34,176 units of lot 01156P between 9/04/96 and 08/01/96. 800 units of lot 01256P between 7/31/96 and 5/07/97. 10,323 units of lot 01356P between 10/31/96 and 5/07/97. REASON Variability in assay results (stability). _______________ PRODUCT Fluocinolone Acetonide Cream, USP 0.01%, Rx sold in tubes of 15 g, used as an anti- inflammatory and anti-pruritic agent. Recall #D-250-7. CODE Lot #5143-1 EXP 6/97. MANUFACTURER G & W Laboratories, South Plainfield, New Jersey. RECALLED BY Manufacturer, by letter on May 2, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide and Puerto Rico. QUANTITY 1,930 tubes were distributed. REASON Inconsistent assays during stability testing. _______________ PRODUCT Vasosulf Ophthalmic Solution (Sulfacetamide Sodium 15% phenylephrine Hydrochloride 0.125%), 5 ml and 15 ml sizes. Recall #D-251-7. CODE Lot numbers: VE3433 and VE3459. MANUFACTURER OMJ Pharmaceuticals, San German, Puerto Rico. RECALLED BY CIBA Vision Ophthalmics, Duluth, Georgia, by letter August 8, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide QUANTITY 12,552 units for lot VE3433; 6,588 fo lot VE3459 were distributed. REASON Labeling error -- Phenylephrine HCL content on insert reads 25 mg/ml and carton reads 125 mg/ml. The correct amount is 1.25 mg/ml, which is correctly listed on the container and carton display panel. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT Red Blood Cells. Recall #B-1141-7. CODE Unit #49FF26362. MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma. RECALLED BY Manufacturer, by telephone on April 9, 1997, and by letter on April 17, 1997. Firm-initiated recall complete. DISTRIBUTION Oklahoma. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose body temperature had not been documented. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Platelets, Pheresis; d) Platelets, for further manufacture; e) Fresh Frozen Plasma. Recall #B-1158/1162-7. CODE Unit numbers: a) 2004852, 2004853, 2004855, 2004871, 2004872, 2004875, 2025381, 5044803, 5044805, 5044816, 5044827, 5044839, 5050383, 5050386, 5050387, 5050394, 5050414 b) 2004853, 2004855, 5050383, 5050386, 5050387, 5050390, 5050414 c) 5043389, 5043395, 5043396, 5043400, 5043401, 5043404 d) 2004852, 5043399, 5043403, 5050394 e) 2004852, 2004853, 2004872, 2004875, 2025381, 5044810, 5044816, 5044825, 5044827, 5044839, 5050414. MANUFACTURER LifeShare, Inc., also known as Lorain County Blood Bank, Inc., Elyria, Ohio. RECALLED BY Manufacturer, by telephone on May 28, 1996, followed by letters dated June 10, 1996. Firm-initiated recall complete. DISTRIBUTION Ohio and Florida. QUANTITY a) 17 units; b) 7 units; c) 6 units; d) 4 units; e) 11 units were distributed. REASON Blood products were incorrectly tested for the antibody to the hepatitis B core antigen (anti-HBc). _______________ PRODUCT Source Plasma. Recall #B-1192-7. CODE Unit numbers: 79350334, 79028837, 79027199, 79025263. MANUFACTURER Bio-Blood Components, Inc., Gary, Indiana. RECALLED BY Manufacturer, by fax on April 9, 1997. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 4 units were distributed. REASON Blood product were collected from a donor who received a tattoo within twelve months of donation. _______________ PRODUCT Abbott HCV EIA 2.0 Diagnostic Kit, Hepatitis C Virus Encoded Antigen. Recall #B-1208-7. CODE Lot Number: 29807M100 EXP 29 Oct 97. MANUFACTURER Abbott Laboratories, Diagnostics Division, Abbott Park, Illinois. RECALLED BY Manufacturer, by telephone on July 25 and 28, 1997, followed by letter dated July 30, 1997. Firm-initiated recall ongoing. DISTRIBUTION Florida, Illinois, Michigan, Tennessee, Texas, Washington state. QUANTITY 69 - 5000 test kits of HCV EIA were distributed; firm estimated that 20% of the HCV EIA kits remained on the market at time of recall initiation. REASON HCV EIA kits may contain a small number of ungrounded coated beads. _______________ PRODUCT Abbott HIVAG-1 Monoclonal EIA Diagnostic Kit Antibody to Human Immunodeficiency Virus Type 1 (HIV-1). Recall #B-1210-7. CODE Lot Number: 28087M201, EXP 17 Sep 97. MANUFACTURER Abbott Laboratories, Diagnostics Division, Abbott Park, Illinois. RECALLED BY Manufacturer, by telephone on July 25 and 28, 1997, followed by letter dated July 30, 1997. Firm-initiated recall ongoing. DISTRIBUTION California, Florida, Illinois, Iowa, Louisiana, Massachusetts, Michigan, South Carolina, Tennessee, Texas. QUANTITY 269 - 1000 test kits were distributed, with the firm estimating that 3% of the kits remain on the market. REASON HIVAG-1 EIA kits may contain a small number of ungrounded coated beads. _______________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes Removed; c) Platelets; d) Cryoprecipitate; e) Fresh Frozen Plasma; f) Recovered Plasma. Recall #B-1212/1217-7. CODE a) 19037-1569 19034-6451 19039-2788 19035-9984 19033-9393 19033-1129 19032-5963 19038-5359 19029-0570 19027-4568 19029-5428 19026-8142 b) 19031-7300 c) 19029-0570 19028-5359 d) 19026-8142 19031-7300 19039-2788 19035-9984 e) 19037-1569 f) 19026-8142 19031-7300 19035-9984 19039-2788 19034-6451 19029-0570 19027-4568 19029-5428 19033-1129 19032-5963 19028-5359. MANUFACTURER United Blood Services, Reno, Nevada. RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by letter on February 18, 1997. Firm-initiated recall ongoing. DISTRIBUTION Alabama, California, Florida, Louisiana, North Carolina, Nevada, South Dakota, Tennessee, Texas, Switzerland. QUANTITY a) 12 units; b) 1 unit; c) 2 units; d) 4 units; e) 1 unit; f) 11 units were distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1, Western blot negative. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1219/1220-7 CODE Unit 12060-0552. MANUFACTURER United Blood Services, Albuquerque, New Mexico. RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by letter on February 4, 1997. Firm-initiated recall complete. DISTRIBUTION Nevada and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were drawn from an unsuitable donor. _______________ PRODUCT a) Platelets; b) Recovered Plasma. Recall #B-1221/1222-7. CODE Unit #20037-7281. MANUFACTURER United Blood Services, Lafayette, Louisiana. RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by letters on March 19, 1997, April 9, 1997, and July 7, 1997. Firm-initiated recall complete. DISTRIBUTION Louisiana and North Carolina. QUANTITY 1 unit of each component was distributed. REASON Blood products were drawn from an unsuitable donor. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1223/1224-7. CODE Unit #20019-5651. MANUFACTURER United Blood Services, Lafayette, Louisiana. RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by letter on February 18, 1997, and April 9, 1997. Firm-initiated recall complete. DISTRIBUTION Louisiana and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products, which tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1, Western blot negative, were distributed. _______________ PRODUCT Baxter Gammagard Solvent/Detergent Treated Immunoglobulin G (Immune Globulin Intravenous (Human): a) Baxter's Gammagard S/D 5G; b) Baxter's Gammagard S/D 10G. Recall #B-1225/1226-7. CODE Lot # 2620M010AB, 2620M011AA, 2620M012AA. MANUFACTURER Baxter Healthcare Corporation, Hyland Division, Glendale, California. RECALLED BY Manufacturer, by letter dated April 24, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 10,173 vials were distributed. REASON Baxter's IGIV solvent/detergent vials are misbranded in that they incorrectly list the reconstitution volume as 10 ml. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-1227/1229-7. CODE Unit #12093-5239. MANUFACTURER United Blood Services, Albuquerque, New Mexico. RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by letter on March 19, 1997. Firm-initiated recall complete. DISTRIBUTION New Mexico and North Carolina. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a medical history of hepatitis. ______________ PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c) Platelets; d) Recovered Plasma. Recall #B-1230/1233-7. CODE Unit numbers: a) 10499-7432, 10496-0963, 10490-4257; b) 10499-7432, 10496-0963; c) 10490-4257; d) 10499-7432, 10496-0963. MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by letter on May 24, 1997. Firm-initiated recall complete. DISTRIBUTION Alabama, Montana, Nevada, Switzerland. QUANTITY a) 3 units; b) 2 units; c) 1 unit; d) 2 units were distributed. REASON Blood products were collected from a donor with a history of cancer. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-1234/1236-7. CODE Unit numbers: a) 29083-5722; b) 29083-5722, 29085-5309; c) 29083-5722. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by letters on February 5, 1997, and May 2, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois and Mississippi. QUANTITY a) 1 unit; b) 2 units; c) 1 unit was distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1, Western blot negative. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma. Recall #B-1238/1241-7. CODE Unit numbers: a) 12415-9782, 12414-7079, 12412-7323, 12409-7504, 12078-6408, 12408-2436, 12090-2683, 12088-9992, 12093-2339, 12080-5112 b) 12412-7323, 12088-9992, 12090-2683, 12409-7504 c) 12078-6408, 12415-9782, 2414-7079 d) 12093-2339, 12408-2436, 12409-7504, 12412-7323, 12090-2683, 12088-9992, 12080-5112. MANUFACTURER United Blood Services, Albuquerque, New Mexico. RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by letters on March 11, 1997, and July 7, 1997. Firm-initiated recall ongoing. DISTRIBUTION Colorado, North Carolina, New Mexico, Texas, Switzerland. QUANTITY a) 10 units; b) 4 units; c) 3 units; d) 7 units were distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1, Western blot negative. _______________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c) Recovered Plasma. Recall #B-1242/1244-7. CODE Unit numbers: a) 22055-1442 and 22061-2904 b) 22061-2904; c) 22055-1442. MANUFACTURER United Blood Service, Las Vegas, Nevada. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated March 11, 1997. Firm-initiated recall complete. DISTRIBUTION Nevada and North Carolina. QUANTITY a) 2 units; b) 1 unit; c) 1 unit was distributed. REASON Blood products were collected from a donor who was previously deferred for high risk behavior. _______________ PRODUCT Recovered Plasma. Recall #B-1245-7. CODE Unit #14001-8286. MANUFACTURER United Blood Services, Lafayette, Louisiana. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated March 19, 1997. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who was previously deferred. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1246/1247-7. CODE Unit #20035-3643. MANUFACTURER United Blood Services, Lafayette, Louisiana. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letters dated March 19, 1997 and April 9, 1997. Firm-initiated recall complete. DISTRIBUTION Louisiana and North Carolina. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who was previously deferred for a history of intravenous (IV) drug use. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1248/1249-7. CODE Unit numbers: 19224-1747 and 19038-9200. MANUFACTURER United Blood Services, Reno, Nevada. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated February 18, 1997. Firm-initiated recall complete. DISTRIBUTION Nevada and Switzerland. QUANTITY 2 units of each component was distributed. REASON Blood products were collected from a donor who previously made a therapeutic donation, were distributed. _______________ PRODUCT a) Red Blood Cells; b) Plasma. Recall #B-1250/1251-7. CODE Unit #29GY02968. MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by letters dated April 28, 1997, and June 6, 1997. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with Amyopathic dermatomyositis. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1252/1253-7. CODE Unit #24KE10855. MANUFACTURER American Red Cross Blood Service, Louisville, Kentucky. RECALLED BY Manufacturer, by letters dated April 23 and 18, 19997. Firm-initiated recall complete. DISTRIBUTION Puerto Rico and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who received a hepatitis B booster vaccine. _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1254/1255-7. CODE Unit #22KQ07215. MANUFACTURER American Red Cross, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by telephone and by letter dated January 24, 1997. Firm-initiated recall complete. DISTRIBUTION Pennsylvania and New Jersey. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1256/1257-7. CODE Unit #22GP69729. MANUFACTURER American Red Cross, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by telephone and by letter dated November 5, 1996. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Cryoprecipitate; d) Recovered Plasma. Recall #B-1259/1262-7. CODE Unit numbers: a) 22052-0182; b) 22044-5302; c) 22052-0182; d) 22052-0182, 22044-5302. MANUFACTURER United Blood Services, Las Vegas, Nevada. RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by letter on July 7, 1997. Firm-initiated recall complete. DISTRIBUTION Nevada and Switzerland. QUANTITY a) 1 unit; b) 1 unit; c) 1 unit; d) 2 units were distributed. REASON Blood products were collected from a donor with a history of hepatitis. _______________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c) Recovered Plasma. Recall #B-1263/1265-7. CODE a) 10211-4613, 10204-5931, 10154-3691; b) 10211-4613, 10204-5931; c) 10154-3691. MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by letter on July 7, 1997. Firm-initiated recall complete. DISTRIBUTION Arizona and Switzerland. QUANTITY a) 3 units; b) 2 units; c) 1 unit was distributed. REASON Blood products were drawn from an unsuitable donor. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Platelets, Pheresis; d) Platelets, for further manufacture; e) Fresh Frozen Plasma. Recall #B-1163/1167-7. CODE Unit numbers: a) 2004854, 2004856, 2004857, 2004858, 2004859, 2004861, 2004862, 2004864, 2004865, 2004866, 2004867, 2004868, 2004869, 2004870, 2004874, 2021800, 2021801, 2021802, 2021804, 2021805, 2021806, 2025371, 2025372, 2025373, 2025374, 2025375, 2025376, 2025377, 2025379, 2025383, 2025385, 2025386, 2025387, 2025388, 2025389, 2025390, 2025391, 2025392, 2025394, 2025395, 2025397, 2025398, 2025399, 2025979, 2025980, 2025981, 5044789, 5044790, 5044791, 5044793, 5044794, 5044795, 5044797, 5044798, 5044799, 5044800, 5044801, 5044802, 5044806, 5044807, 5044808, 5044809, 5044811, 5044812, 5044813, 5044815, 5044817, 5044818, 5044819, 5044820, 5044821, 5044822, 5044824, 5044828, 5044829, 5044830, 5044831, 5044832, 5044833, 5044834, 5044836, 5044837, 5044838, 5050385, 5050389, 5050391, 5050392, 5050393, 5050395, 5050396, 5050397, 5050399, 5050400, 5050401, 5050402, 5050403, 5050404, 5050405, 5050406, 5050407, 5050408, 5050409, 5050410, 5050411, 5050415 b) 2004856, 2004857, 2004858, 2004859, 2025371, 2025372, 2025373, 2025374, 2025375, 2025377, 5044791, 5044792, 5044793, 5044798, 5044799, 5050389, 5050391, 5050392, 5050395, 5050397, 5050398, 5050399, 5050400, 5050401, 5050403, 5050404, 5050405, 5050406, 5050408, 5050410, 5050412, 5050415 c) 5043390, 5043391, 5043392, 5043393, 5043394 d) 2004854, 2025376, 5044789, 5044795, 5050385, 5050402, 5050407, 5050409, 5050411, 5050412 e) 2004858, 2004868, 2004874, 2025376, 2025981, 5044789, 5044792, 5044820, 5044829, 5044830, 5050398, 5050403, 5050404, 5050411. MANUFACTURER LifeShare, Inc., also known as Lorain County Blood Bank, Inc., Elyria, Ohio. RECALLED BY Manufacturer, by telephone on May 28, 1996, followed by letter dated June 10, 1996. Firm-initiated recall complete. DISTRIBUTION Ohio and Florida. QUANTITY a) 105 units; b) 32 units; c) 5 units; d) 10 units; e) 14 units were distributed. REASON Blood products were incorrectly tested for the antibody to the hepatitis B core antigen (anti-HBc). ________________ PRODUCT Platelets, Pheresis. Recall #B-1168-7. CODE Unit numbers: 1207386, 1207412, 1207427, 1207432. MANUFACTURER Houchin Community Blood Bank, Bakersfield, California. RECALLED BY Manufacturer, by telephone on August 14, 1996. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 4 units were distributed. REASON Blood products were not tested for the HIV-1 p24 antigen. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT SURGIKOS Latex Surgical Gloves, Sterile. Recall #Z-754/761-7. CODE Model Numbers Lot Numbers 6455 95100001 through 97020001 6460 95100011 through 97030103 6465 95100103 through 97030209 6470 95080726 through 97020508 6475 95081504 through 97031002 6480 95082296 through 97021603 6485 95071653 through 97021805 6490 95071695 through 97021901. MANUFACTURER Fime-Darby Latex Products Seramban,Malaysia RECALLED BY Johnson & Johnson Medical, Inc., Arlington, Texas, by letter, July 1, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 417,000 pairs were distributed. REASON Open seals were found, thereby compromising the sterility of the medical devices. _______________ PRODUCT Kilit Ampules, are used to monitor steam-under-pressure sterilization cycles, labeled under the brand names Cotrell Limited and SPS Medical: a) Kilit Ampules, Catalog Number 4312018 b) Kilit Ampules, Catalog Number 4312019 c) Kilit Ampules, Catalog Number 4399511 (manufactured for Cottrell, Ltd.); d) Kilit Ampules, Catalog Number 4399155 (manufactured for SPS Medical). Recall #Z-764/767-7. CODE All lots of the above Catalog Numbers are subject to recall. MANUFACTURER Becton Dickinson Microbiology Systems, Cockeysville, Maryland. RECALLED BY Becton Dickinson Microbiology Systems, Sparks, Maryland, by letter in May 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY Firm estimates none remains on the market. REASON Devices do not meet labeled D-values and some are outside the label claim for spore count. This could produce incorrect result when applied to the standard microbiological sterilization cycle. _______________ PRODUCT Electric Powered Moist Heating Pad with momentary switch: a) Roberts Hydro Thero Pad Model 1327-1, Pro-Temp MHP Model 1327-1 b) Roberts Hydro Thero pad Model 1313-1. Recall #Z-796/797-7. CODE a) Control numbers 971247, 971260 through 971324, 971349 through 971362, 971397 through 971431, 971482 through 971561, 970541 through 970660 b) control numbers 970889 through 970911, 970924 through 971025, 971081 through 971200, 971212, 971144 through 971147. MANUFACTURER Roberts Manufacturing Company, Inc., Baltimore, Maryland. RECALLED BY Manufacturer, by telephone on May 23, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY a) 315 units; b) 246 units were distributed. REASON During assembly of the product it was discovered that splitting the electric power cord caused copper wires to become exposed. _______________ PRODUCT Heartstart Battery Charger, Catalog #902850, intended to charge the following batteries: 90 11 00 Heartstart Battery 90 43 00 Heartstart Battery 90 11-90 Heartstart 3000 Training Battery 90 41 00 Heartstart 1000 Training Battery. Recall #Z-802-7. CODE Lot Nos. 97182A, 97212A. MANUFACTURER Ault, Inc., Minneapolis, Minnesota (battery supplier/responsible firm). RECALLED BY Laerdal Medical Corp., Wappingers Falls, New York, by letter dated June 27, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 301 battery charges are affected. REASON The two lots of battery chargers were missing a resistor that controls the lights and charging activity in the battery charger. _______________ PRODUCT Contour Mammography System, Model M-CTR-1 and M-CTR-2 dedicated for mammographic imaging using X-ray. Recall #Z-859/860-7. CODE Units with Serial Numbers in 29000 series are Contour 2 models and all others are Contour 1 (425 Serial #s): BMC-27503, BMC-27504, BMC-27505, BMC-27506, BMC-27509, BMC-27510, BMC-27512, BMC-27513, BMC-27514, BMC-27516, BMC-27520, BMC-27522, BMC-27523, BMC-27524, BMC-27526, BMC-27527, BMC-27528, BMC-27578, BMC-27579, BMC-27580, BMC-27581, BMC-27582, BMC-27583, BMC-27584, BMC-27586, BMC-27587, BMC-27596, BMC-27597, BMC-27598, BMC-27599, BMC-27600, BMC-27602, BMC-27603, BMC-27604, BMC-27605, BMC-27606, BMC-27607, BMC-27608, BMC-27609, BMC-27610, BMC-27611, BMC-27612, BMC-27613, BMC-27614, BMC-27615, BMC-27634, BMC-27635, BMC-27636, BMC-27637, BMC-27638, BMC-27639, BMC-27641, BMC-27642, BMC-27643, BMC-27644, BMC-27646, BMC-27647, BMC-27648, BMC-27649, BMC-27650, BMC-27652, BMC-27654, BMC-27655, BMC-27656, BMC-27658, BMC-27701, BMC-27702, BMC-27703, BMC-27705, BMC-27706, BMC-27707, BMC-27708, BMC-27710, BMC-27711, BMC-27712, BMC-27713, BMC-27714, BMC-27715, BMC-27716, BMC-27717, BMC-27718, BMC-27719, BMC-27720, BMC-27721, BMC-27722, BMC-27723, BMC-27724, BMC-27725, BMC-27726, BMC-27727, BMC-27729, BMC-27730, BMC-27731, BMC-27732, BMC-27733, BMC-27734, BMC-27735, BMC-27737, BMC-27738, BMC-27739, BMC-27740, BMC-27741, BMC-27742, BMC-27743, BMC-27745, BMC-27746, BMC-27753, BMC-27754, BMC-27755, BMC-27756, BMC-27757, BMC-27758, BMC-27759, BMC-27760, BMC-27761, BMC-27762, BMC-27763, BMC-27764, BMC-27765, BMC-27766, BMC-27767, BMC-27768, BMC-27770, BMC-27771, BMC-27772, BMC-27773, BMC-27774, BMC-27775, BMC-27777, BMC-27778, BMC-27779, BMC-27780, BMC-27780, BMC-27781, BMC-27783, BMC-27784, BMC-27801, BMC-27802, BMC-27803, BMC-27804, BMC-27805, BMC-27806, BMC-27807, BMC-27808, BMC-27809, BMC-27812, BMC-27813, BMC-27814, BMC-27815, BMC-27816, BMC-27817, BMC-27818, BMC-27820, BMC-27821, BMC-27822, BMC-27823, BMC-27824, BMC-27828, BMC-27829, BMC-27831, BMC-27832, BMC-27833, BMC-27834, BMC-27835, BMC-27836, BMC-27837, BMC-27838, BMC-27840, BMC-7841, BMC-27842, BMC-27844, BMC-27845, BMC-27846, BMC-27848, BMC-27849, BMC-27850, BMC-27851, BMC-27852, BMC-27853, BMC-27855, BMC-27858, BMC-27859, BMC-27860, BMC-27861, BMC-27865, BMC-27866, BMC-27867, BMC-27868, BMC-27869, BMC-27870, BMC-27871, BMC-27872, BMC-27873, BMC-27874, BMC-27875, BMC-27876, BMC-27877, BMC-27888, BMC-27889, BMC-27890, BMC-27891, BMC-27892, BMC-27893, BMC-27895, BMC-27896, BMC-27897, BMC-27898, BMC-27900, BMC-27901, BMC-27902, BMC-27903, BMC-27904, BMC-27905, BMC-27906, BMC-27907, BMC-27908, BMC-27909, BMC-27910, BMC-27911, BMC-27912, BMC-27913, BMC-27914, BMC-27915, BMC-27916, BMC-27919, BMC-27920, BMC-27922, BMC-27923, BMC-27924, BMC-27925, BMC-27926, BMC-27927, BMC-27928, BMC-27929, BMC-27930, BMC-27931, BMC-27932, BMC-27935, BMC-27936, BMC-27938, BMC-27939, BMC-27940, BMC-27942, BMC-27943, BMC-27945, BMC-27946, BMC-27956, BMC-27957, BMC-27959, BMC-27960, BMC-27961, BMC-27962, BMC-27965, BMC-27966, BMC-27968, BMC-27969, BMC-27971, BMC-27972, BMC-27973, BMC-27974, BMC-27975, BMC-27976, BMC-27979, BMC-27981, BMC-27982, BMC-27985, BMC-27986, BMC-27989, BMC-27990, BMC-27993, BMC-27994, BMC-27995, BMC-27997, BMC-27998, BMC-27999, BMC-28001, BMC-28002, BMC-28003, BMC-28004, BMC-28005, BMC-28015, BMC-28016, BMC-28017, BMC-28018, BMC-28019, BMC-28020, BMC-28021, BMC-28022, BMC-28024, BMC-28025, BMC-28026, BMC-28027, BMC-28032, BMC-28043, BMC-28044, BMC-28045, BMC-28047, BMC-28048, BMC-28050, BMC-28052, BMC-28053, BMC-28054, BMC-28056, BMC-28057, BMC-28059, BMC-28061, BMC-28062, BMC-28063, BMC-28064, BMC-28065, BMC-28066, BMC-28067, BMC-28069, BMC-28071, BMC-28072, BMC-28074, BMC-28075, BMC-28076, BMC-28096, BMC-28097, BMC-28098, BMC-28099, BMC-28103, BMC-28104, BMC-28105, BMC-28109, BMC-28110, BMC-28111, BMC-28112, BMC-28113, BMC-28114, BMC-28116, BMC-28117, BMC-28118, BMC-28119, BMC-28120, BMC-28122, BMC-28125, BMC-28126, BMC-28127, BMC-28128, BMC-28129, BMC-28130, BMC-28133, BMC-28134, BMC-28135, BMC-28136, BMC-28139, BMC-28140, BMC-28141, BMC-28142, BMC-28143, BMC-28144, BMC-28151, BMC-28152, BMC-28154, BMC-28155, BMC-28157, BMC-28158, BMC-28167, BMC-28168, BMC-28171, BMC-28174, BMC-28175, BMC-28176, BMC-28182, BMC-28183, BMC-28185, BMC-28186, BMC-28187, BMC-28188, BMC-28195, BMC-28217, BMC-28219, BMC-28223, BMC-28224, BMC-28225, BMC-28230, BMC-28252, BMC-28253, BMC-28257, BMC-29000, BMC-29001, BMC-29002, BMC-29003, BMC-29004, BMC-29005, BMC-29006, BMC-29007, BMC-29008, BMC-29009, BMC-29010, BMC-29014, BMC-29015, BMC-29016, BMC-29017, BMC-29022, BMC-29023, BMC-29024, BMC-29026, BMC-29027, BMC-29028, BMC-29045, BMC-29046, BMC-29047, BMC-29048, BMC-29049, BMC-29051, BMC-29052, BMC-29053, BMC-29054, BMC-29055, BMC-29056, BMC-29057, BMC-29059, BMC-29060, BMC-29061, BMC-29062, BMC-29063, BMC-29066, BMC-29068, BMC-29069, BMC-29072, BMC-29073 & BMC-29076. The following serial numbers are for the 58 units which the firm had shipped retrofit kits between 9/95 and 2/97: (Bennett still needs to verify that these retrofits were performed by dealers' servicemen): BMC-27830, BMC-29129, BMC-29196, BMC-29081, BMC-28042, BMC-29021, BMC-27941, BMC-29019, BMC-27856, BMC-29177, BMC-28051, BMC-27616, BMC-27610, BMC-27944, BMC-27987, BMC-27996, BMC-27517, BMC-29168, BMC-29067, BMC-27970, BMC-27967, BMC-27769, BMC-28023, BMC-27937, BMC-27525, BMC-27507, BMC-28172, BMC-27508, BMC-29011, BMC-29013, BMC-29020, BMC-27827, BMC-27988, BMC-29287, BMC-29018, BMC-28026, BMC-27847, BMC-29025, BMC-29139, BMC-27843, BMC-29112, BMC-27826, BMC-27958, BMC-28046, BMC-28156, BMC-29249, BMC-29121, BMC-29003, BMC-28058, BMC-27744, BMC-27501, BMC-27653, BMC-29012, BMC-27857, BMC-28121, BMC-27640, BMC-29074 and BMC-27977. MANUFACTURER Bennett X-Ray Technologies, subsidiary of Trex Medical Corporation, Copiague, New York. RECALLED BY Manufacturer, by letter dated March 5, 1997. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 483 units subject to retrofit. REASON This diagnostic x-ray device was found to be in non-compliance with the Federal Performance Standard for Diagnostic X-ray Systems and their Major Components. The 150 watt bulb may cause overheating in the collimator gears. _______________ PRODUCT Multigas Analyzer, simultaneously monitors gas concentrations and alerts clinical personnel when the concentration of anesthetic agents, oxygen, carbon dioxide or nitrous oxide falls outside the defined limits. Recall #Z-862-7. CODE Serial Number Range 518-000001 through 518-000551 (non inclusive), Software Versions less than 1.00.26 MANUFACTURER Spacelabs Medical, Inc., Redmond, Washington. RECALLED BY Manufacturer, by letter on May 15, 1997. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 303 devices were distributed. REASON The multigas analyzer may display an incorrect agent identification. _______________ PRODUCT Narkomed Anesthesia Machines, intended to deliver anesthetic gases and oxygen and may be used to ventilate patients. Recall #Z-863-7. CODE Product Manufactured Between December 5, 1996, and March 21, 1997. MANUFACTURER North American Drager, Telford, Pennsylvania. RECALLED BY Manufacturer, by letter dated June 6, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 281 units were distributed. REASON The oxygen flush button on some of these machines may stick in the open position. _______________ PRODUCT 3100A Flexible Patient Circuit Body, Part #769960, Used With Model 3100 HFOV, for ventilatory support and treatment of respiratory failure. Recall #Z-864-7. CODE Lot #042297. MANUFACTURER Sensormedics, Inc., Yorba Linda, California. RECALLED BY Surgical Technologies, Inc., Brea, California, by telephone on July 2, 1997. Firm-initiated recall ongoing. DISTRIBUTION Illinois, Pennsylvania, The Netherlands, Canada, Argentina. QUANTITY 54 boxes were distributed. REASON The dump valve and temperature port subassembly near the patient end of the circuit body was reversed due to an assembly error. _______________ PRODUCT Epstein-Barr Virus-Viral Capsid Antigen IgG Enzyme-linked Immunosorbent Assay, Product No. 2325700 (International), 425700 (Domestic), Lot No. 2325700-120 (International), 425700-120 (Domestic), for in-vitro diagnostic use. Recall #Z-865-7. CODE Lot #120 EXP 11/97. MANUFACTURER Trinity Biotech (formerly Clark Laboratories), Jamestown, New York. RECALLED BY Manufacturer, by letter dated July 25, 1997. Firm-initiated recall ongoing. DISTRIBUTION New Jersey and international. QUANTITY 960 kits were distributed. REASON The absorbance of the kit calibrator has dropped below the acceptable optical density range of 0.250. _______________ PRODUCT Oxygen Pressure Regulator with Constant Flow: a) Regulator Model No. L270-020 for the following kits: L151JD, L175-010, L175-010D, L175-010JD, L175-011D, L175-011JD, L175-014, L175-01R, L175-030, L175-030D, L175-030JD, L175-03R, L175-140, L444, L444-010, L515, L515-010, L515D, L515JD, L520, L520-010, L521, L523, L523-100, L524, L525, L526, L541-020, L541-040, L542-020, L542-040, L561, L561-010, L561-020, L567, L574, L594, L902001, L902002, L902003, L520-100 b) Regulator Model No. L270-050 for the following kits: L228 and L228-030. Recall #Z-866/867-7. CODE All regulators distributed prior to 4/11/97. MANUFACTURER Allied Healthcare Products, Inc., St. Louis, Missouri. RECALLED BY Manufacturer, by letter dated May 20, 1997, and by telephone on May 23, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 150,000 regulators were distributed. REASON The device was involved in fires which occurred as a result of contamination introduced into the oxygen regulators during maintenance or use. _______________ PRODUCT Consensus Knee Femoral Component, Nonporous CoCr, Size 5 Right, for joint replacement. Recall #Z-868-7. CODE Lot No. 230224A. MANUFACTURER US Medical Products, Inc., Austin, Texas. RECALLED BY Manufacturer, by telephone on May 22, 1997. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 2 units were distributed. REASON The labeling stated product was a right knee component, but the component in the package was a left knee component. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT Dual Lumen 7Fr. Catheter (DLC-7D), Urodynamics Catheterization Trays (TCL-7) that include DLC-7D Catheters. Recall #Z-762/763-7. CODE Lot numbers: a) 4617701; b) 2617802. MANUFACTURER Life-Tech, Inc., Houston, Texas. RECALLED BY Manufacturer, by letter,on or about dated June 30, 1997 Firm-initiated recall ongoing. DISTRIBUTION Nationwide QUANTITY 360/30 cartons were distributed. REASON The catheters were shipped with a partially occluded pressure lumen. RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III === _______________ PRODUCT OptiCare Opti-Pak containing Aureo SP-250 (medicated swine feed premix containing chlortetracycline, sulfamethazine and penicillin. Recall #V-041-7. CODE Lots 611055D, 611056D, 6120312D, 6120313D, 7040666D, 7040667D. MANUFACTURER Hubbard Milling Company, Mankato, Minnesota. RECALLED BY Manufacturer, by telephone on June 19, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois, Indiana, Iowa, North Dakota, Ohio, and South Dakota. QUANTITY 1284 20-pound bags were distributed. REASON Incorrect withdrawal time of 7 days printed on the labeling instead of the required 15 days and misidentification of sulfamethazine as sulfathiazine. END OF ENFORCEMENT REPORT FOR AUGUST 27, 1997. BLANK PAGES MAY FOLLOW.End of Enforcement Report for