September 17, 1997 97-38 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============ _______________ PRODUCT Surimi (Imitation Crab) Spread. The 8 oz. containers are labeled as "Surimi Crab Spread" and the 4 lb. containers are labeled as "Imitation Crab Spread". Recall #F-819-7. CODE 8 oz. containers with "Use by" date "8/31/97"; 4 lb. containers are uncoded and thus are all under recall. MANUFACTURER Silver Creek Farms, Twin Falls, Idaho. RECALLED BY Manufacturer, on or about August 12, 1997, and by press release on August 13, 1997. Firm-initiated recall complete. DISTRIBUTION Oregon, Utah, Idaho, Wyoming, Nevada. QUANTITY 558 pounds distributed. This is broken down into 53 cases (12-8 ounce cups per case) and 20 cases (3-4 pound tubs per case). REASON The product is contaminated with Listeria monocytogenes. _______________ PRODUCT Strawberry Frozen Yogurt, in 3 gallon tubs, 1/2 gallon, quart, and pint containers, under the following labels: Our Own, Licks, and Muhlenberg Foods. Recall #F-820-7. CODE 161. MANUFACTURER Muhlenberg Foods, Reading, Pennsylvania.RECALLED BY Manufacturer, by telephone on July 31, 1997, and by press release on August 1, 1997. Firm-initiated recall ongoing. DISTRIBUTION Pennsylvania. QUANTITY 12 pint, 40 quart, 38 half gallon, and 11 3-gallon containers. REASON Product is contaminated with Listeria monocytogenes. _______________ UPDATE Refrigerated potato salad products, which appeared in the September 3, 1997 Enforcement Report is being updated as follows: PRODUCT Refrigerated Potato Salad Products produced by Orval Kent Food Products in 1 lb., 2 lb. and 3 lb. plastic retail containers under the Orval Kent, Pathmark, Demoulas, Giant of Landover Maryland, Acme Markets and Marsh Supermarkets labels and five and ten lb. bulk containers under the Orval Kent (also 30 lb.), Salad Plus, Signature Salads, Signature Delights, Sysco Classic, Sysco Block & Barrel, Alliant, PYA Monarch, Matthew's Salad House and Metromedia labels as follows: a) Orval Kent Deluxe Potato Salad, 3/10 lb., UPC 79453-13005 b) Alliant Prestige Mustard Potato Salad with Salad Dressing, Alliant Foodservice Inc., Dist., Deerfield, IL 60015, 3/10 lb., UPC 08077-84131 c) Alliant Prestige American Potato Salad with Salad Dressing, 3/10 lb., UPC 08077-84132 d) Alliant Prestige American Potato Salad with Mayonnaise, 3/10 lb., UPC 08077-84138 e) Sliced Mustard Potato Salad i) PYA Monarch, Dist. by P.Y.A./Monarch, Virginia Beach, VA 23455-3701, 1/10 lb., UPC 86270-01457 ii) Orval Kent, 3/10 lb., UPC 79453-40204 f) Diced Potato Salad with Egg i) Super G, Distributed by Super G, Inc., Landover, MD 20785 12/1 lb. ii) Orval Kent, 3/10 lb., UPC 79453-40304 g) Orval Kent Classic Potato Salad, 2/5 lb., UPC 79453-40756 h) Sliced Potato Salad with Egg i) Acme Corner Deli Cuisine, Distributed by Acme Markets, Inc., Malvern, PA 19355, 12/1 lb., UPC 79453-04453 ii) Sysco, Distributed by Sysco Corporation, Houston, TX 77077-2099, 3/10 lb., UPC 74865-10108 iii) Orval Kent, 3/10 lb., UPC 79453-41004 1/10 lb., UPC 79453-44106 i) Baked Style Potato Salad i) Orval Kent, 2/5 lb., UPC 79453-41756 ii) Alliant Prestige, 2/5 lb., UPC 08077-70502 j) Orval Kent Amish Potato Salad, 1/10 lb., UPC 79453-41804 k) Metromedia Steakhouses Company, L.P. Southern Style Potato Salad, Mfg. by Orval Kent Food Company, Inc., Wheeling, IL 60090 for Exclusive Use in the Metromedia Steakhouses Company, LP, 3/10 lb. l) German Potato Salad i) Sysco, 1/10 lb., UPC 74865-07978 ii) Pathmark, Packed for Pathmark Stores, Inc., Woodbridge, NJ 07086, 12/1 lb., UPC 020670 iii) Orval Kent, 2/5 lb., UPC 79453-45200 1/10 lb., UPC 79453-45204 m) Diced Potato Salad I) Orval Kent, 6/5 lb., UPC 79453-01313 6/3 lb., UPC 79453-42815 3/10 lb., UPC 79453-42883 6/2 lb., UPC 79453-42885 1/10 lb., UPC 79453-42886 12/1 lb., UPC 79453-42888 ii) Sysco, 3/10 lb., UPC 74865-18777 iii) Orval Kent Canadian label, 1/10 lb., UPC 79453-20842 6/3 lb., UPC 79453-28526 n) Orval Kent 100% Fat Free Potato Salad, 1/10 lb., UPC 79453-43004 o) Fat Free Roasted Garlic Red Potato Salad i) Orval Kent Signature Delights, 2/5 lb., UPC 79453-43387 ii) Sysco Imperial, 2/5 lb., UPC 74865-40707 p) Sliced White Potato Salad i) Demoulas, Distributed by Demoulas Supermarket, Tewksbury, MA 01876, 12/1 lb., UPC 70226-65006 ii) Sysco, 3/10 lb. iii) Orval Kent, 3/10 lb., UPC 79453-44001 and 1/10 lb. q) Sysco Reduced Fat Country Style Potato Salad with Egg, 3/10 lb., UPC 74865-31311 r) Red Skinned Potato Salad i) Orval Kent Signature Delights, 2/5 lb., UPC 79453-44787 ii) Alliant Prestige, 2/5 lb., UPC 08077-70503 s) Country Style Potato Salad with Egg i) PYA Monarch, 1/10 lb., UPC 86270-07179 ii) Sysco, 3/10 lb., UPC 74865-18775 iii) Orval Kent, 1/10 lb., UPC 79453-45904 1/30 lb., UPC 79453-45949 iv) Orval Kent Homestyle Egg & Potato Salad, 2/5 lb., UPC 79453-45000 t) Southern Style Mustard Potato Salad i) PYA Monarch, 1/10 lb., UPC 86270-01456 ii) Orval Kent, 1/10 lb. and 1/10 lb., UPC 79453-43104 u) Orval Kent Low Country Potato Salad, 1/10 lb., UPC 79453-45704 v) Sliced Potato Salad with Vegetables i) Chilled Salad, Distributed by G.D. Matthews & Sons, Charlestown, MA 02129, 3/10 lb. ii) Pathmark, 12/1 lb. 6/2 lb. 6/3 lb. iii) Orval Kent, 6/3 lb., UPC 79453-45815 12/1 lb., UPC 79453-45888 3/10 lb., UPC 79453-45849 w) Diced Mustard Potato Salad i) Acme Corner Deli Cuisine, 12/1 lb., UPC 79453-05653 6/2 lb., UPC 79453-05953 ii) Orval Kent, 3/10 lb., UPC 79453-46301 6/3 lb., UPC 79453-46315 x) Homestyle Potato Salad i) Deli Fresh at Marsh, Dist. by Marsh Supermarkets, Inc., Indianapolis, IND 46256-3350, 12/1 lb., UPC 79453-46425 ii) Orval Kent, 1/10 lb., UPC 79453-46404 y) Orval Kent Red Royale Potato Salad, 2/5 lb., UPC 79453-41456 z) Sysco Southern Style Mustard Potato Salad, 3/10 lb., UPC 74865-33830 aa) Super G Diced Potato Salad with Vegetables, 6/2 lb., 3/10 lb., UPC 79453-14001, 12/1 lb. bb) Alliant Prestige Gourmet Potato Salad, 2/5 lb., UPC 08077-70504 cc) Orval Kent Signature Specialties Natural Potato & Herb Salad 2/5 lb., UPC 79453-80056 dd) Orval Kent Signature Specialties Red Potato & Egg Salad Supreme, 2/5 lb., UPC 79453-80656 ee) Sour Cream & Dill Potato Salad i) Salads Plus, Dist by Orval Kent, 3/10 lb. and 1/10 lb., UPC 79453-88005 ii) Block & Barrel Deluxe Potato Salad, Dist. by Sysco Corp., 2/5 lb., UPC 74865-40685. Recall# F-684/F-713-7. CODE All potato salad products with expiration dates prior to September 15, marked with the code "W7", i.e. SEP15W7. MANUFACTURER Orval Kent Food Company, Inc., Wheeling, Illinois. RECALLED BY Manufacturer beginning on August 4, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Puerto Rico, and Canada. QUANTITY 5,644,170 pounds were distributed. REASON Potato salads may be contaminated with Listeria monocytogenes. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Pepperidge Farm Frozen Assorted Mini & Large Danish Pastries: a) Pepperidge Farm Frozen Assorted Mini Danish Pastries UPC# 510006747; b) Pepperidge Farm Frozen Assorted Large Danish Pastries UPC# 510007812. Recall #F-809/810-7. CODE All product with "use by" dates between April 21, 1997 and August 14, 1997. MANUFACTURER Campbell Soup National HQ, Camden, New Jersey. RECALLED BY Pepperidge Farms, Inc., Norwalk, Connecticut, by letter dated February 20, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY a) 37,064 cases (96 pastries per case); b) 14,730 cases (48 pastries per case) were distributed. REASON The pastries contain excessive levels of sulfites. _______________ PRODUCT Cock brand Tapioca Pearl. Recall #F-811-7. CODE All including EMB 75113N (Best Before 1996). MANUFACTURER Unknown in Thailand. RECALLED BY Hong Thai Foods Corporation, Brooklyn, New York, by letter dated April 7, 1997. Firm-initiated recall complete. DISTRIBUTION New York, New Jersey, Pennsylvania, Connecticut, Massachusetts, Illinois, Virginia, Florida. QUANTITY 49 cases were distributed. REASON Product contains the following undeclared colors: FD&C Yellow, No. 5, FD&C Blue No. 1, and FD&C Red No. 3. _______________ UPDATE Brown Sugar, in 1, 2, 4, 25, 50 and 100 lb packages. Recall #F-806-7, which appeared in the September 10, 1997 Enforcement Report should read: CODE Lot #46092/46106. RECALLED BY Manufacturer, on or about May 5, 1996. QUANTITY Approximately 2 million pounds. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT Ensure Plus, vanilla flavored, high-calorie nutritional drink, packed in 8 fluid ounce plastic cans. Recall #F-808-7. CODE Cans are identified with lot code: 28778L5 EXP1 MAY 98. MANUFACTURER Ross Products Division, Columbus, Ohio. RECALLED BY Manufacturer, by telephone on June 24, 1997, followed by fax. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 2,208 cases were distributed. REASON Product bears the label of another food and contains erroneous label information regarding identity and nutrient content. RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II ======= _______________ PRODUCT Nectar Watermist a non alcohol body spray made from natural distilled water extracted from blossoms of orange trees packaged into .5 ounce, 4 ounce, 8 ounce and 16 ounce glass bottles. Recall #F-807-7. CODE The codes under recall consists of all product codes shipped prior to July 28, 1997 and includes the following items: 4 oz. Nectar WaterMist Item #FG-8120D-00 Packaging Lot #s 71611, 71621, 71631; 8 oz. Nectar WaterMist, Item #FG-8123D-00, Packaging Lot #s 71641, 71651; 8 oz. Nectar WaterMist (tester), Item # PG-7427D-00, Packaging Lot #s 71641, 71651; Bulk lot #s .5 oz Nectar (tester) sample, Item # PG-7421D-00, Packaging lot #7F09A (only given to sales reps); Dramming/Nectar bulk (3 X 16 oz.), Item #PG-7740D-00, Packaging Lot# 7F09A. MANUFACTURER Allure Cosmetics, San Leandro, California Herba Aromatica, Hayward, California (importer of scented floral water). RECALLED BY The Donna Karan Beauty Company (DKBC) New York, New York, by telephone visit and fax beginning on July 28, 1997, followed by letter on August 1, 1997. Firm-initiated recall ongoing. DISTRIBUTION California, New York, Washington state, Oregon, Virginia, Pennsylvania, Maryland, New Jersey, Massachusetts, Connecticut, Florida, Minnesota, Illinois, Wisconsin, Indiana, Michigan, Texas. QUANTITY Item #FG-8120D-00 - 3,606 units - 4 oz Nectar Item #FG-8123D-00 - 1,967 units - 8 oz Nectar Item #PG-7427D-00 - 713 units - 8 oz Watermist Item #PG-7426D-00 - 4,028 units - 5 oz Nectar Item #PG-7440D-00 - 65 units - Dramming bulk (3 x16 oz) were distributed. REASON Product is contaminated with Burkholderia cepacia, a pathogen. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II =========== _______________ PRODUCT Thiopental Sodium for Injection, USP, 5 gram/vial, in 200 ml vials, in 10 packs of vials of Thiopental Sodium without kits under the Gensia label, kits and vial ten packs) and the Ohmeda label (kits), for preparation of intravenous stock solution only. Recall #D-265-7. CODE Lot numbers: P6P825,P7A817, P7A818 (Ohmeda Kit label), P6A317P1, P6P312, (Gensia label/10 pak) and P6S815 (Gensia Kit label). MANUFACTURER Gensia Laboratories, Ltd., Irvine, California. RECALLED BY Manufacturer, by letter on April 21, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide and Puerto Rico. QUANTITY Approximately 7,900 kits and 9,000 vials in ten packs were distributed. REASON Vials were found to contain glass particles. _______________ PRODUCT Captopril (Capoten) 25 mg Tablets, individually (1 tablet) labeled, single blister packed tablets with labeled single unit plastic overwrap, Rx, used in the treatment of hypertension. Recall #D-266-7. CODE Lot #J5J65A EXP 8/99. MANUFACTURER ER Squibb & Sons, Inc., Division of Bristol Myers Squibb, Medical Department, Princeton, New Jersey. RECALLED BY AmeriSource Health Services, doing business as American Health Packaging (AHP), Columbus, Ohio, by telephone on or about October 22, 1996. Firm-initiated recall ongoing. DISTRIBUTION Ohio, Tennessee, Massachusetts. QUANTITY 130 amber bags (13,000 tablets) were distributed. Firm estimates none remains on the market. REASON Labeling error: Incorrect product identification - Plastic overwrap declares the product as Warfarin Sodium (Coumadin) 2 mg Tablets. Each individual blister label is correctly labeled. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ========== _______________ PRODUCT Ciprofloxacin HCl (Cipro), 500 mg tablets, individually (1 tablet) labeled single blister packed tablets with a plastic overwrap, an antibiotic. Recall #D-264-7. CODE Lot #6BCJ EXP 2/99. MANUFACTURER Bayer Corporation Pharmaceutical Division, West Haven, Connecticut.. RECALLED BY AmeriSource Health Services, Columbus, Ohio, doing business as American Health Packaging (AHP), by telephone on or about March 11, 1997. Firm-initiated recall ongoing. DISTRIBUTION Ohio, Tennessee, Massachusetts. QUANTITY 90 amber bags (9,000 tablets) were distributed; firm estimates none remains on the market. REASON Labeling: error on declared strength. Plastic overwrap declares the product as 250 mg. _______________ UPDATE Recall #D-171-7, Regular Strength Enteric Coated Aspirin Tablets, 325 mg, packaged in 100, 250, and 500 count bottles of various lots, which appeared in the May 14, 1997 Enforcement Report as a Class II recall has been reclassified to a Class III recall. _______________ UPDATE Recall #D-259/260-7, Baclofen Tablets which appeared in the September 10, 1997 Enforcement Report should read: MANUFACTURER: Biocraft Laboratories, Elmwood Park, New Jersey. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT Red Blood Cells. Recall #B-1193-7. CODE Unit #M46536. MANUFACTURER Lane Memorial Blood Bank, Eugene, Oregon. RECALLED BY Manufacturer, by visit on October 8, 1996. Firm-initiated recall complete. DISTRIBUTION Oregon. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who engaged in high risk behavior. _______________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Platelets; d) Fresh Frozen Plasma. Recall #B-1344/1347-7. CODE Unit numbers: a) 29123-1232, 29092-0971, 29128-0189, 29093-9146, 29119-4436, 29125-8658, 29122-3879, 29082-2745, 29081-2570; b) 29131-8807; c) 29123-1232, 29092-0971, 29093-9146, 29125-8658, 29122-3879, 29131-8807; d) 29123-1232, 29092-0971, 29128-0189, 29122-3879, 29082-2745, 29081-2570. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by letter on either May 30, 1996, June 5, 1996, or July 5, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois, Florida, Switzerland. QUANTITY a) 9 units; b) 1 unit; c) 6 units; d) 6 units were distributed. REASON Blood products tested negative for the antibody to the human T-lymphotropic virus I (anti-HTLV-1) but were collected from donors who previously tested repeatedly reactive for anti-HTLV-1, Western blot negative or indeterminate. _______________ PRODUCT Platelets, Pheresis. Recall #B-1350-7. CODE Unit #21P69503. MANUFACTURER American Red Cross, Portland, Oregon. RECALLED BY Manufacturer, by telephone on June 12, 1997, and by letter dated June 17, 1997. Firm-initiated recall complete. DISTRIBUTION Oregon. QUANTITY 1 unit was distributed. REASON Blood product had an unacceptable platelet count. _______________ PRODUCT Platelets. Recall #B-1368-7. CODE Unit #25FR70821. MANUFACTURER American Red Cross Blood Services, Syracuse, New York. RECALLED BY Manufacturer, by letter dated November 3, 1995. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 unit was distributed. REASON Platelets were prepared from a unit of whole blood designated as "difficult" phlebotomy. _______________ PRODUCT Red Blood Cells, Washed. Recall #B-1378-7. CODE Unit numbers: 16337-4457, 16337-4456, 16337-4474, 16337-7805. MANUFACTURER Blood Systems, Inc., Hattiesburg, Mississippi. RECALLED BY Manufacturer, by letter dated March 21, 1997. Firm-initiated recall ongoing. DISTRIBUTION Mississippi. QUANTITY 4 units were distributed. REASON Blood products were labeled with extended expiration dates. _______________ PRODUCT a) Cryoprecipitate; b) Fresh Frozen Plasma. Recall #B-1387/1388-7. CODE Unit numbers: a) 8580139 and 8551475; b) 8574398 and 8526946. MANUFACTURER The Blood Center, New Orleans, Louisiana. RECALLED BY Manufacturer, by letter and or telephone between September 8, 1995 and October 9, 1995. Firm-initiated recall complete. DISTRIBUTION Louisiana. QUANTITY 2 units of each component were distributed. REASON Blood products contained anti-D antibodies, but were labeled as negative for unexpected antibodies. _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1402/1403-7. CODE Unit numbers: a) 16339-7346, 16339-7344, 16339-7341; b) 16339-7347, 16339-7346, 16339-7344, 16339-7343, 16339-7342, 16339-7341, 16339-7340, 16339-7000. MANUFACTURER Blood Systems, Inc., Meridian, Mississippi. RECALLED BY Manufacturer, by telephone on June 3, 1997. Firm-initiated recall complete. DISTRIBUTION Mississippi. QUANTITY a) 3 units; b) 8 units were distributed. REASON Blood products were tested using samples that were stored at an unacceptable temperature. _______________ PRODUCT Red Blood Cells. Recall #B-1404-7. CODE Unit numbers: 16339-8033, 16339-8036, 16339-8037, 16339-8039, 16339-8041, 16339-8042, 16339-8044, 16339-8045, 16339-8046, 16339-8047, 16339-8048, 16339-8050, 16339-8051, 16339-8052. MANUFACTURER Blood Systems, Inc., Meridian, Mississippi. RECALLED BY Manufacturer, by telephone on June 9, 1997. Firm-initiated recall complete. DISTRIBUTION Mississippi. QUANTITY 14 units were distributed. REASON Blood products were tested using samples that were stored at an unacceptable temperature. _______________ PRODUCT Red Blood Cells. Recall #B-1408-7. CODE Unit #8637621. MANUFACTURER The Blood Center, New Orleans, Louisiana. RECALLED BY Manufacturer, by telephone June 7, 1996. Firm-initiated recall complete. DISTRIBUTION Louisiana. QUANTITY 1 unit was distributed. REASON Blood product was not properly tested for HIV-Ag. _______________ UPDATE United Blood Services, Scottsdale, Arizona recall which appeared in the September 3, 1997 Enforcement Report should read: PRODUCT: a) Red Blood Cells; b) Fresh Frozen Plasma; c) Recovered Plasma. Recall #B-1281/1283-7. CODE: Unit numbers: 10230-8872, 10175-4045. QUANTITY: 4 units were distributed. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT Recovered Plasma. Recall #B-1348-7. CODE 29093-9146, 29119-4436, 29125-8658, 29131-8807. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by letter on either May 30, 1996, June 5, 1996 or July 5, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois, Florida, Switzerland. QUANTITY 4 units were distributed. REASON Blood products tested negative for the antibody to the human T-lymphotropic virus (anti-HTLV-1), but were collected from donors who previously tested repeatedly reactive for anti-HTLV-1, Western blot negative or indeterminate. _______________ PRODUCT Fresh Frozen Plasma. Recall #B-1385-7. CODE Unit #16335-3005 and 16335-3007. MANUFACTURER Blood System, Inc., doing business as United Blood Services, Hattiesburg, Mississippi. RECALLED BY Manufacturer, by telephone on October 19, 1996 and by letter on November 22, 1996. Firm-initiated recall complete. DISTRIBUTION Mississippi. QUANTITY 2 units were distributed. REASON Fresh Frozen Plasma was not frozen within eight hours of phlebotomy. _______________ PRODUCT Red Blood Cells, Deglycerolized. Recall #B-1386-7. CODE Unit numbers: 29444-5147, 29444-5055. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by telephone on June 23, 1996, and by letter on July 30, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 2 units were distributed. REASON Deglycerolized Red Blood Cells were not treated with rejuvenating solution prior to freezing. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Lead Protective Aprons used to shield patients during x-ray procedures. Recall #Z-904-7. CODE Serial numbers: 6502-6523, 6532-6537, 6551, 6555-6559, 6567-6569, 6578-6579, 6585-6642, 6648-6668, 6670-6678, 6681-6686, 1237-1238, 3896-3909, 3911-1912, 3914-3919, 3966-3968, 3975-3976, 3993, 3998, 4040-4042, 1237-1238. MANUFACTURER Pulse Medical, Inc., Davie, Florida. RECALLED BY Manufacturer, by letter on June 10 and 16, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 153 aprons were distributed. REASON Radiation protection devices contain lead contaminated with small amounts of radioactive substances. _______________ PRODUCT Abiomed BVS 5000 Bi-Ventricular Support System Transistor on Compressor Driver. The device (PMA #900023) provides ventricular assist and restores hemodynamics in patients suffering severe cardiac dysfunction. It consists of three major components: the BVS Console, the BVS pumps and the BVS Cannulae. Recall #Z-909-7. CODE Console Catalog No. 0005-000, Console serial numbers: 1314,1336, 1339, 1341-1352, 1352, 1355. MANUFACTURER Abiomed, Inc., Danvers, Massachusetts. RECALLED BY Manufacturer, by letter dated June 30, 1997. Firm-initiated recall complete. DISTRIBUTION Arkansas, California, Florida, Illinois, Louisiana, Michigan, Missouri, New Jersey, Oklahoma, Texas. QUANTITY 17 consoles were distributed. REASON The console can stop during use and go into continuous alarm. END OF ENFORCEMENT REPORT FOR SEPTEMBER 17, 1993. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for