April 22, 1998 98-16 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Carole's Texas Edibles Black Eye Pea Salsa, a Texas caviar, in 9 ounce and 16 ounce jars. Recall #F-357-8. CODE Lots with pull codes NOV27,97 and JUN19,98. MANUFACTURER Henry's Dream, Houston, Texas. RECALLED BY Carole's Food Specialties, Pearland, Texas, by telephone on September 5, 1997, followed by visits on September 12 and 20, 1997. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 183 9-ounce, 275 16-ounce and 6 32-ounce jars were distributed. REASON Product is an acidified food which was manufactured without registration or process filing. _______________ PRODUCT Chocolate Candy Eggs wrapped in foil and contained in 7 ounce cello bags. Recall #F-450-8. CODE None. MANUFACTURER De Bas Chocolatier, Fresno, California. RECALLED BY Starbucks Coffee Company, Seattle, Washington, by telephone on March 18, 1998. Firm-initiated recall complete. DISTRIBUTION Nationwide and Canada. QUANTITY 239 packages were distributed. REASON Product contains undeclared almonds. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT Canned Chicken of the Sea Whole Oysters, in 8 ounce cans. Recall F-333-8. CODE OYBL TY2 6528. MANUFACTURER Shinjin Mooslan Company, Ltd., Republic of Korea. RECALLED BY Chicken of the Sea, International (formerly Van Camp Seafood), San Diego, California, by letter faxed on March 16, 1998. Firm-initiated recall ongoing. DISTRIBUTION Colorado, Iowa, Illinois, Kansas, Kentucky, Michigan, Ohio, South Dakota, Wisconsin. QUANTITY 2,086 cases (12 cans per case) were distributed; firm estimated little product remained on market at time of recall initiation. REASON Product is unfit for food in that it contains insect and animal filth. _______________ PRODUCT Clintec NuBasics Complete Nutrition Chocolate Splash, 250 Calories, 250 ml, a complete nutrition diet drink for use as directed by a health care professional. Recall #F-334-8. CODE 7257EW992 (on cases) and 7257EWB1C992X (on cans) Use By 14Sep98 (on cans). MANUFACTURER Nestle Food Company, Nutritional Products Division, Eau Claire, Wisconsin. RECALLED BY Nestle Clinical Nutrition, Deerfield, Illinois, by letter dated March 11, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 516 cases (24 cans per case) were distributed. REASON The product is misbranded, in that, some cans are labeled as NuBasics "Plus" instead of NuBasics "Regular". RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II ======= _______________ PRODUCT Hawaiian Tropic Herbal Aloe with Tea Tree Oil Aromatherapy, promoted as a skin moisturizer lotion, in 16 fluid ounce containers. Recall #F-446-8. CODE Lot numbers: 11011997, 11021997, 11031997. MANUFACTURER Tanning Research Laboratories, Inc., Ormond Beach, Florida. RECALLED BY Manufacturer, by mail or fax with memorandum dated January 15, 1998. Firm-initiated recall ongoing. DISTRIBUTION Florida, Kentucky, South Carolina, Hawaii, and international. QUANTITY Approximately 3,150 boxes (12 bottles per case) were distributed. REASON Product may be contaminated with Burkholderia cepacia. _______________ PRODUCT Boraxo brand Waterless Hand Cleaners: a) Boraxo Lotion Waterless Hand Cleaner with Pumice, 1 gallon, Item 388; b) Boraxo Waterless Hand Cleaner Gel - Mechanic's Strength with Pumice, Item 364; c) Boraxo Waterless Hand Cleaner Gel - Mechanic's Strength, 16 oz., Item 357, 4 lb. 8 oz., Item 356. Recall #F-447/449-8. CODE a) G016I2 574, I266I2 852, K256I2 1029, F267I2 413; b) K116I2 986; c) F067I2 368A (16 oz); K196I2 1019, B137I2 095, H157I2 557, H187I2 557 (4 lb 8 oz). MANUFACTURER International Chemical, Inc., Amherst, New York. RECALLED BY Dial Corporation, Scottsdale, Arizona, by telephone beginning on November 6, 1997, followed by letter dated November 6, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide and Canada. QUANTITY 29,545 cases were distributed. REASON The products may be contaminated with Burkholderia cepacia. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ========== _______________ PRODUCT Resacol Tablets, OTC analgesic product that is supposed to contain 325 mg of acetaminophen and 65 mg of caffeine, in bottles of 30. Recall #D-116-8. CODE Lot #960607 EXP 7/98. MANUFACTURER Lex Pharmaceutical Corporation, Medly, Florida. RECALLED BY Lyren Pharmaceutical Corporation, Caguas, Puerto Rico (own label distributor), by letter. Firm-initiated recall ongoing. DISTRIBUTION Puerto Rico. QUANTITY Approximately 2,862 bottles were distributed. REASON Misbranding - Active ingredient strength incorrectly labeled: Acetaminophen declared at .325 mg per tablet sand caffeine at .65 mg (decimal point incorrectly added in front of each active ingredient). RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-519/521-8. CODE Unit #42M10310. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by letter dated January 8 and 17, 1996. Firm-initiated recall complete. DISTRIBUTION Ohio and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were incorrectly tested for the human immunodeficiency virus type 1 (anti-HIV-1. _______________ PRODUCT Red Blood Cells. Recall #B-816-8. CODE Unit #2263299. MANUFACTURER Central Texas Regional Blood and Tissue Center, Austin, Texas. RECALLED BY Manufacturer, by telephone on October 28, 1997. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had no hematocrit check recorded during screening. _______________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes Removed; c) Platelets; d) Fresh Frozen Plasma; e) Source Leukocytes; f) Recovered Plasma. Recall #B-835/840-8. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana. RECALLED BY Manufacturer, by telephone and by letter dated June 30, 1997. Firm-initiated recall complete. DISTRIBUTION Indiana, Massachusetts, Utah, New Jersey, Switzerland. QUANTITY a) 31 units; b) 1 units; c) 20 units; d) 5 units; e) 3 units; f) 26 units were distributed. REASON Blood products tested negative for HBsAg, HIVAG, HTLV, or Hbc but collected from donors who initially tested reactive for HBsAg, HIVAG, HTLV, or HBc, with units not retested in duplicate, and donors were incorrectly reentered. _______________ PRODUCT Red Blood Cells. Recall #B-847-8. CODE Unit #38-19932. MANUFACTURER Michigan Community Blood Centers, Saginaw, Michigan. RECALLED BY Manufacturer, by letter on June 26, 1997. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of Hashimoto's Disease. _______________ PRODUCT Allergenic Extracts: a) Birch Mix PRW b) Mold Mix #4. Recall #B-851/852-8. CODE a)Lot # B97J0222; b) Lot # A07J0130. MANUFACTURER Bayer Corporation, Bayer Pharmaceutical Division, Allergy Products, Spokane, Washington. RECALLED BY Manufacturer, by telephone on March 19-20, 23-24, 1998. Firm-initiated recall ongoing. DISTRIBUTION Delaware, Georgia, Iowa, Illinois, Indiana, Michigan, Missouri, Nevada, New York, Ohio, Pennsylvania, Virginia, Washington state, Wisconsin, Maryland, Spain. QUANTITY a) 18 50-ml vial; b) 18 50-ml vials were distributed. REASON Allergenic extract products were mislabeled in that Birch PRW contained Mold Mix #4, and Mold Mix #4 contained Birch Mix PRW. _______________ PRODUCT Platelets. Recall #B-863-8. CODE Unit #20001400. MANUFACTURER Ashford Blood Bank, Inc., Ashford Medical Center, Santurce, Puerto Rico. RECALLED BY Manufacturer, by telephone on July 11, 1997. Firm-initiated recall complete. DISTRIBUTION Puerto Rico. QUANTITY 1 unit was distributed. REASON Blood product tested initially reactive for the antibody to the Hepatitis B surface antigen (HBsAg), and antibody to the Hepatitis B core antigen (HBc), with no confirmatory test. _______________ PRODUCT Fresh Frozen Plasma. Recall #B-864-8. CODE Unit #0101861. MANUFACTURER Ashford Blood Bank, Inc., Ashford Medical Center, Santurce, Puerto Rico. RECALLED BY Manufacturer, by telephone on October 30, 1996. Firm-initiated recall complete. DISTRIBUTION Puerto Rico. QUANTITY 1 unit was distributed. REASON Blood product tested initially reactive for the antibody to the Hepatitis B surface antigen (HBsAg), and antibody to the Hepatitis B core antigen (HBc), with no confirmatory test. _______________ PRODUCT Platelets. Recall #B-869-8. CODE Unit #1453295. MANUFACTURER Central Kentucky Blood Center, Lexington, Kentucky. RECALLED BY Manufacturer, by telephone on January 9, 1998. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit was distributed. REASON Platelets were prepared from a unit collected from a donor who had taken aspirin within 24 hours of donation. _______________ PRODUCT Red Blood Cells. Recall #B-870-8. CODE Unit #1411732. MANUFACTURER Central Kentucky Blood Center (CKBC), Lexington, Kentucky. RECALLED BY Manufacturer, by letter dated January 9, 1998. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area designated as endemic for malaria. _______________ PRODUCT Red Blood Cells. Recall #B-879-8. CODE Unit #0103864. MANUFACTURER Ashford Blood Bank, Inc., Ashford Medical Center, Santurce, Puerto Rico. RECALLED BY Manufacturer, by telephone on September 2, 1997. Firm-initiated recall complete. DISTRIBUTION Puerto Rico. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor in which viral marker testing (HIV-1/2, HBsAg, HTLV-1, Hbc HCV) was not conducted. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-880/881-8. CODE Unit #06GF02934. MANUFACTURER American Red Cross, Los Angeles, California. RECALLED BY Manufacturer, by letter on August 28, 1996, and September 10, 1996. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of cancer. _______________ PRODUCT Source Plasma. Recall #B-882-8. CODE Unit #65279410. MANUFACTURER Bio-Blood Components, Inc., Columbus, Ohio. RECALLED BY Manufacturer, by letter dated February 3. 1998, followed by fax. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was not quarantined after the donor provided information regarding a previous positive test for HIV. ________________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-883/884-8. CODE Unit numbers: a) 06FT31765, 06FT30927 b) 06FT31765. MANUFACTURER American Red Cross, Los Angeles, California. RECALLED BY Manufacturer, by letter dated August 26, 1996. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY a) 2 units; b) 1 unit was distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. _______________ PRODUCT Platelets. Recall #B-885-8. CODE Unit #06LP46162. MANUFACTURER American Red Cross, Los Angeles, California. RECALLED BY Manufacturer, by telephone on September 27, 1996. Firm-initiated recall complete. DISTRIBUTION Puerto Rico. QUANTITY 1 unit was distributed. REASON Platelets were prepared from a unit collected from a donor who had taken aspirin or piroxicam within three days of donation. _______________ PRODUCT Red Blood Cells. Recall #B-886-8. CODE Unit #0101148. MANUFACTURER Ashford Blood Bank, Inc., Santurce, Puerto Rico. RECALLED BY Manufacturer, by telephone on July 5, 1996. Firm-initiated recall complete. DISTRIBUTION Puerto Rico. QUANTITY 1 unit was distributed. REASON Blood product was collected from a autologous donor in which viral marker testing (HIV-1/2, HBsAg, HTLV-1, HBc, HCV) was not conducted, and was distributed for homologous use. _______________ PRODUCT Recovered Plasma. Recall B-887-8. CODE Unit #0102132. MANUFACTURER Ashford Blood Bank, Inc., Santurce, Puerto Rico. RECALLED BY Manufacturer, by telephone on December 30, 1996. Firm-initiated recall complete. DISTRIBUTION Puerto Rico. QUANTITY 1 unit was distributed. REASON Blood product was incorrectly labeled as Fresh Frozen Plasma and distributed for transfusion. _______________ PRODUCT Recovered Plasma. Recall #B-890-8. CODE Unit #53H45983. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by fax on December 19, 1997, and by letter on January 27, 1998. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product tested negative for the hepatitis B surface antigen (HBsAg), but was collected from a donor who previously tested repeat reactive for HBsAg, with no confirmatory testing. _______________ PRODUCT Platelets, Pheresis. Recall #B-891-8. CODE Unit #06KS18020. MANUFACTURER American Red Cross, Los Angeles, California. RECALLED BY Manufacturer, by telephone on January 13, 1997. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product had an unacceptable platelet count. _______________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-892/893-8. CODE Unit #06GV45023. MANUFACTURER American Red Cross, Los Angeles, California. RECALLED BY Manufacturer, by letter dated March 4, 1997. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of cancer. _______________ PRODUCT Platelets, Pheresis. Recall #B-894-8. CODE Unit #06KN07097. MANUFACTURER American Red Cross, Los Angeles, California. RECALLED BY Manufacturer, by letter dated March 13, 1997. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who received a tattoo within 12 months of donation. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma. Recall #B-895/898-8. CODE Unit #06GH31724, 06GH22840; b) 06GH31724, 06GH22840; c) 06GH31724; d) 06GH22840. MANUFACTURER American Red Cross, Los Angeles, California. RECALLED BY Manufacturer, by letter dated August 11 or 12, 1997. Firm-initiated recall complete. DISTRIBUTION California, Idaho, Texas. QUANTITY a) 2 units; b) 2 units; c) 1 unit; d) 1 unit was distributed. REASON Blood products were collected from a donor with a history of cancer. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT Platelets. Recall #B-775-8. CODE Unit #42M83002. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by letter dated July 2, 1996. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of Whole Blood identified as a difficult draw. _______________ PRODUCT Red Blood Cells. Recall #B-860-8. CODE Unit #18GH27779. MANUFACTURER American Red cross, Lansing, Michigan. RECALLED BY Manufacturer, by telephone and letter on January 8, 1998. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who exceeded the donation acceptance criteria for body temperature. _______________ PRODUCT Red Blood Cells. Recall #B-888-8. CODE Unit #20001420. MANUFACTURER Ashford Blood Bank, Inc., Ashford Medical Center, Santurce, Puerto Rico. RECALLED BY Manufacturer, by telephone on July 18, 1997. Firm-initiated recall complete. DISTRIBUTION Puerto Rico. QUANTITY 1 unit was distributed. REASON Blood product with an extended expiration date was distributed. _______________ PRODUCT a) Fresh Frozen Plasma; b) Cryoprecipitated AHF. Recall #B-908/909-8. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANUFACTURER American Red Cross Blood Services, Los Angeles, California. RECALLED BY Manufacturer, by letters between April 1 and 28, 1997. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY a) 46 units; b) 17 units were distributed. REASON Blood products were stored at an unacceptable temperature. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-911/913-8. CODE Unit #53C90705. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by telephone on August 21, 1997, followed by letter dated September 2, 1997, and by fax on August 27, 1997. Firm-initiated recall complete. DISTRIBUTION Pennsylvania, District of Columbia, California. QUANTITY 1 unit of each component was distributed. REASON Blood products were incorrectly tested for the hepatitis B surface antigen (HBsAg). _______________ UPDATE Recall #B-560-8, Red Blood Cells, Unit #17182 -2574, recalled by Blood Systems, Inc., which appeared in the April 8, 1998 Enforcement Report is being recinded. The information was previously reported as Recall B-271-8, in the December 3, 1997, Enforcement Report. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I ========== _______________ PRODUCT Plazlyte Sterilization System, a low temperature gas plasma sterilization system used to sterilize flat surgical stainless steel medical instruments in Tyvek and Tyvek/Mylar packaging, marketed as an alternative to ETO sterilization. Recall #Z-491-8. CODE Model ABT 1.0, All serial numbers. MANUFACTURER AbTox, Inc., Mundelein, Illinois. RECALLED BY Manufacturer, by letter March 31, 1998. Firm-initiated recall ongoing. See also FDA talk paper T98017, April 2, 1998. DISTRIBUTION Nationwide. QUANTITY 163 units were distributed. REASON The sterilization system can leave copper and zinc salt residues on ophthalmic devices sterilized in the system. These compounds are corrosive to mucous membranes and the human cornea. The device defect presents a high risk of serious adverse health consequences. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Bard 9 Fr 30 cc RediGuard IAB (Intra-Aortic Balloon) Catheter and Introducer Kit, Indicated for use in: refractory left ventricular failure, cardiogenic or septic shock, unstable refractory angina, impending infarction, etc. Models: a) R930D-Used with Datascope Adapter. Introducer No Sidearm b) R930DS-Used with Datascope Adapter. Introducer with SideArm c) R930U- Supplied with three adapters for use in pumps: Datascope, Arrow, Bard. Introducer No Sidearm d) R30US- Supplied with three adapters for use in pumps: Datascope, Arrow, Bard. Introducer With Sidearm. Recall #Z-476/479-8. CODE Model Serial Numbers R930D AU80007, AU80014, AU80047 R930D SAU80005, AU80004, AU80024, AU80049 R930U AU80225 R30US AU80227, AU80230, AU80218. MANUFACTURER Bard Cardiac Assist Products, C.R. Bard, Inc., Chelmsford, Massachusetts. RECALLED BY Manufacturer, by telephone on March 24, 1998, followed by letter on March 26, 1998. Firm-initiated recall ongoing. DISTRIBUTION Missouri, Pennsylvania, Kansas. QUANTITY 11 units were distributed. REASON Balloon membrane scored or cut causing helium to leak. _______________ PRODUCT Becton Dickinson SafetyGlide Needle. Recall #Z-497-8. CODE Reorder #305905, Lot #7C905. MANUFACTURER Becton Dickinson Industrial Site, Columbus, Nebraska. RECALLED BY Becton Dickinson and Company, Franklin Lakes, New Jersey, by a "Hold Memo" and by telephone on June 3, 1997, by letter faxed on June 4, 1997, and by certified mail on June 11, 1997. Firm-initiated recall complete. DISTRIBUTION New Jersey, California, Alabama, Florida. QUANTITY 50,400 units were distributed. REASON The "safety", a plastic piece that extends to cover the syringe, breaks at the hinge region with a lower rate than the firms specifications allow. _______________ PRODUCT True/Flex Trauma Cortical Bone Screws: a) Catalog Nos. 06-4524, 06-4528, 06-4532, 06-4536, 06-4540, 06-4544, 06-4548, 06-4552, 06-4556, 06-4560, 06-5535, 06-5540, 06-5545, 06-5550, 06-5555, 06-5565, 06-5570, 06-5575, 06-5580 b) Catalog Nos. 07-4524, 07-4536, 07-4540, 07-4548, 07-4552, 07-4556, 07-4560, 07-5540, 07-5545, 07-5565, 07-5570, 07-5575, 07-5580. Recall #Z-499/500-8. CODE Multiple lot numbers manufactured between 3/97 and 1/98: a) 68 lots within the lot number range 252261 through 311561 b) 26 lots within the lot number range 27183 through 31260. MANUFACTURER North East Surgical Tool Company, Pembroke, Massachusetts. RECALLED BY Encore Orthopedics, Austin, Texas, by letter dated March 5, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Japan. QUANTITY Distribution consisted of 1,371 units with Catalog Numbers 06-4524/5580, of which 244 units were defective, and 269 units with Catalog Numbers 07-4524/5580, of which 160 were defective. REASON There is a potential for inadequate thread engagement with the cortical bone due to the threads not starting close enough to the screw head. _______________ PRODUCT Model 750vs Bear Cub Infant Pressure Ventilator, used to provide ventilatory support to neonates and pediatric patients up to 30 kg. Recall #Z-512-8. CODE All serial numbers. MANUFACTURER Bear Medical Systems, Inc., Riverside, California. RECALLED BY Manufacturer, by fax followed by certified mail between March 9 and 18, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 952 units were distributed. REASON The inspiratory pressure and PEEP/CPAP control valves may jam or are difficult to adjust. _______________ PRODUCT Model TED 60T Portable Oxygen Monitor, a microprocessor based oxygen concentration analyzer for use in respirators, incubators, and other medical equipment. Recall #Z-514-8. CODE Devices have individual serial numbers: 158133-158232 158441-158540 159005-159104 159264-159363 159633-159732 160139-160233. MANUFACTURER Teledyne Electronic Technologies Analytical Instruments (TET/AI), City of Industry, California. RECALLED BY Manufacturer, by telephone and/or fax on June 27, 1996. Firm-initiated recall complete. DISTRIBUTION New York, California, Florida, Michigan, Illinois, Ohio, West Virginia, Texas, Kentucky, Georgia, Missouri, New Hampshire, Massachusetts, Louisiana, Kansas, Tennessee, and international. QUANTITY 571 units were distributed. REASON The device gave inaccurate (high) oxygen reading, caused by a defective capacitor. _______________ PRODUCT Artromot-SB (Shoulder bedmount) Continuous Passive Motion Devices, exerciser, used for post-operative continuous mobilization of the shoulder joint. Recall #Z-515-8. CODE Serial numbers: 93460 93470 94480 94490 93461 93471 94481 94491 93462 93472 94482 94492 93463 93473 94483 94493 93464 93474 94484 94494 93465 93475 94485 94495 93466 93476 94486 94496 93467 93477 94487 94497 93468 93478 94488 94498 93469 93479 94489 94499. MANUFACTURER ORMED GmbH (The HUG Group), D-79100 Freiburg I.B. (Germany). RECALLED BY Orthopedic Medical Products, Inc. doing business as ORMED, Pennsauken, New Jersey, by letter on or about August 15, 1997, followed by telephone. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 40 units were distributed. REASON The weld joint of the units may fatigue resulting in rupture of the device. _______________ PRODUCT Glucometer Dex Blood Glucose Test Sensors, Product Code 3610, intended for use in the Glucometer Dex Instrument system to determine blood glucose levels. Recall #Z-516-8. CODE The following lot numbers were distributed in the United States: 1A075AA, 1A076AA, 2A076AA, 1A077AA, 1A078AA, and 1A078BA; Exp. February 1999. The following lot numbers were distributed outside of the United States: 1A052AA, 1A059AA, 1A061AA, 1A062AA, 1A062BA, 1A065AA, 1A066AA, 1A067AA, 1A070AA, 1A070BA, 1A071AA, 1A073AA, 1A074AA, 1A074BA, 1A075AA, 1A076AA, 1A077AA, 1A078AA, 1A078BA, 1B072AA, 1B079AA, 1T048AA, 1T048AB, 1T053AA, 1T056AA, 1T058AA, 1T063AA, 1T069AA, 1T069BA, 2A061AA, 2A066AA, 2A067AA, 2A070AA, 2A073AA, 2A074AA, 2A074BA, 2A076AA, 2A085AA, 2B072AA, 2T048AA, 2T053AA, 2T054AA, 2T056AA, 2T058AA, 2T063AA, 3A065AA, 3A067AA, 3T058AA, 3T063AA, 4T058AA, 5T058AA, AT034AA, AT035AA, AT035BA, AT036AA, AT037AA, AT038AA, AT039AA, AT040AA, AT040BA, AT041AA, AT046AA, AT049AA, BT036AA, BT039AA, BT041AA, BT046AA, CR037BA, CT036AA, and CT046AA. MANUFACTURER Bayer Corporation, Mishawaka, Indiana. RECALLED BY Bayer Corporation, Elkhart, Indiana, by letter dated December 22, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 550,000 packages of 50 sensors were distributed. REASON The device will not fill properly and can give results which fall outside of the acceptable range before its expiration date. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT COBAS Integra Reagent Creatine Kinase-MB, in-vitro diagnostic regent system intended for use on COBAS Integra for the quantitative determination of catalytic activity of CK-MB in serum and plasma. Recall #Z-501-8. CODE Catalog #0737402, Lot #E2640. MANUFACTURER Roche Diagnostic Systems, Kaiseraugst, Switzerland. RECALLED BY Roche Diagnostic Systems, Sommerville, New Jersey, by letter and telephone on July 28, 1997. Firm-initiated recalls complete. DISTRIBUTION Massachusetts, Pennsylvania, Florida, Texas. QUANTITY 18 units were distributed; firm estimates none remains on the market. REASON This lot was showing a decreased recovery for the control serum of about 20%. _______________ PRODUCT Roche brand Integra Ethanol Reagent, in-vitro diagnostic reagent system. Recall #Z-502-8. CODE Product #0737550, Lot numbers: E1633, E1633A, E1740. MANUFACTURER Roche Diagnostics, Kaiseraugst, Switzerland. RECALLED BY Roche Diagnostic Systems, Somerville, New Jersey, by telephone on January 28, 1997, September 12, 1997 and on February 20, 1997. Firm-initiated recall complete. DISTRIBUTION Massachusetts, Rhode Island, New Jersey, New York, Pennsylvania, District of Columbia, South Carolina, Georgia, Iowa, Texas, Israel, Australia, Switzerland. QUANTITY 425 kits were distributed; firm estimates none remains on the market. REASON the Ethanol reagent was unstable causing patient data to be outside the normal ranges. _______________ PRODUCT Onsite (.01%) for Alcohol Test, provides rapid detection of alcohol in saliva or urine. Recall #Z-503-8. CODE Catalog No. 00302, Lot Nos. 60601, 60602. MANUFACTURER Toxilab, Inc., Irvine, California. RECALLED BY Roche Diagnostic Systems, Sommerville, New Jersey, by letter on February 3, 1997, and September 11, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY 407 kits were distributed; firm estimates none remains on the market. REASON An incorrect desiccant packet was placed in the test kits that may have caused false positive results if exposed to high heat and humidity. _______________ PRODUCT Synergy Quad Media Plates, an agar screen recommended for use in predicting the synergistic contribution of an amino glycoside and vancomycin when testing enterococcal isolates requiring combination therapy. Recall #Z-504-8. CODE Product #02-474, Lot #5597 EXP 5/27/97. MANUFACTURER Remel Limited Partnership, Lenexa, Kansas. RECALLED BY Manufacturer, by telephone on April 2, 1997. Firm-initiated recall complete. DISTRIBUTION Michigan and Virginia. QUANTITY 20 units were distributed. REASON The vancomycin used in the agar was subpotent. _______________ PRODUCT Staph Latex Kit, a rapid slide latex agglutination test for detection of coagulase associated with S. Aureus In primary cultures. Recall #Z-505-8. CODE Catalog No. 21-143, Lot No. L10057. MANUFACTURER Remel Limited Partnership, Immunodiagnostics Division, Augusta, Georgia (now closed). RECALLED Remel Limited Partnership, Lenexa, Kansas, by telephone on December 28, 1996 and December 31, 1996. Firm-initiated recall complete. DISTRIBUTION Oklahoma, California, Illinois, Massachusetts, Michigan, Iowa, Florida, Utah, Missouri, Texas, Virginia, Pennsylvania, Georgia, Tennessee, New York, Maryland, Kansas, Alabama and Australia. QUANTITY 61 units were distributed. REASON Some quality control and patient isolates gave false negative results. _______________ PRODUCT Brain Heart Infusion Agar with Vancomycin Media Plates, for use as an agar screen for the detection of vancomycin resistance in enterococci. Recall #Z-506-8. CODE Catalog No. 01-176, Lot No. 5550. MANUFACTURER Remel Limited Partnership, Lexena, Kansas. RECALLED BY Manufacturer, by telephone on May 30, 1996 and June 6, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 3,850 units were distributed. REASON The plates may have growth of Enteroccus Faecalis which may interfere with the test. _______________ PRODUCT Roche Reagent for BUN, in-vitro diagnostic liquid reagent intended for use on COBAS Chemistry systems for the quantitative determination of blood urea nitrogen in serum: a) Product Code 47380; b) Product Code 47381. Recall #Z-507/508-8. CODE Lot Numbers: a) 001, 002, 003; b) 001, 002, 003. MANUFACTURER Medical Analysis Systems, Inc., Camarillo, California. RECALLED BY Roche Diagnostic Systems, Somerville, New Jersey, by letter on February 14, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY Amount Shipped: a) lot 001 - 2195 kits lot 002 - 2195 kits lot 003 - 1086 kits lot 004 - 17 kits b) lot 001 - 394 kits lot 002 - 398 kits lot 003 - 1390 kits. REASON That there was a carryover from the previous test that falsely depressed the BUN results. _______________ PRODUCT Immulite ANTI-TPO AB Test Kit, indicated for in-vitro diagnostic use in the clinical diagnosis of thyroid disease. Recall #Z-509-8. CODE Kit Lot #120 EXP 6/30/98. MANUFACTURER EURO/DPC Ltd., Wales, United Kingdom. RECALLED BY Diagnostic Products Corporation, Los Angeles, California, by telephone on February 2, 1998, followed by visit on February 5, 1998. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 17 kits were distributed. REASON Patient samples had falsely elevated positives. END OF ENFORCEMENT REPORT FOR APRIL 22, 1998. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for