May 6, 1998 98-18 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============ _______________ PRODUCT Queso Fresco Cheese under the following labels, "El Tapatio", 5 ounce and 15 ounce wheels; "El Caporal", 5 ounce and 10 ounce wheels; "La Banderita",15 ounce wheels; and "La Vaca Rica", 12 ounce, 20 ounce, 1.33 pound and 2.25 pound sizes. Recall #F-474-8. CODE All with sell by dates through July 14, 1998. MANUFACTURER Specialty Cheese Company, Lebanon, Wisconsin. RECALLED BY La Hispamex Food Products, Inc., Cicero, Illinois (repacker), by telephone on March 20, 1998, followed by fax and visit. Ongoing recall resulted from sample analysis and follow-up by the North Carolina Department of Agriculture and Consumer Services and the Illinois Department of Public Health. DISTRIBUTION Nationwide. QUANTITY 248,938 pounds were distributed; firm estimated that 30 percent of the cheese remained on market at time of recall initiation. REASON Product is contaminated with Listeria monocytogenes. _______________ PRODUCT Casa Visco brand Italian Style Giardinera, a pickled vegetable medley, in 16 ounce and 32 ounce glass jars. Recall #F-479-8. CODE All codes labeled as "Italian Style". MANUFACTURER Cosmo's Food Products, Inc., West Haven, Connecticut. RECALLED BY Viscusi Wholesale Grocers, Inc., Schenectady, New York, by memorandum dated March 30, 1998, and by press release on March 31, 1998. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, New Jersey, Pennsylvania, Massachusetts, Vermont, Connecticut, New Hampshire. QUANTITY Undetermined. REASON Product contains undeclared sulfites. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT Red Cheek 100% Apple Juice from Concentrate, in 64 fluid ounce plastic containers. Recall #F-473-8. CODE M 70725, M 70728, M 70729, M 70730. MANUFACTURER Mayer Brothers Apple Products, Baker, New York. RECALLED BY Mott's North America, Stamford, Connecticut, by fax letter on October 14, 1997, followed by visit. Firm-initiated recall complete. DISTRIBUTION Massachusetts, Maryland, Vermont, Pennsylvania. QUANTITY 21,136 cases were distributed. REASON Product is unfit for food due to off-odor/off-taste. _______________ PRODUCT Ocean Beauty brand Frozen yellowfin Tuna Steaks, in 10 pound cases. Recall #F-477-8. CODE S0268D. MANUFACTURER Ocean Beauty Seafoods, Inc., Seattle, Washington. RECALLED BY Ocean Beauty Seafoods, Inc., Seattle, Washington, by telephone on March 27, 1998. Firm-initiated recall complete. DISTRIBUTION California, Oregon, Pennsylvania, Texas. QUANTITY 125 cases were distributed; firm estimated that 66 cases remained on market at time of recall initiation. REASON Product is decomposed. RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II ======= _______________ PRODUCT Eye Cream in 1 fluid ounce tubes distributed under Cosmetic Specialty Labs., Inc. (CSLI) and Aularale labels as follows: a) Eye Cream, product number 1019, b) Aularale Eye Nourishing Cream, product number 2481021. Recall #F-475/476-8. CODE a) 890-4; b) 1234567890-6. MANUFACTURER Cosmetic Specialty Labs., Inc., Lawton, Oklahoma. RECALLED BY Manufacturer, by letters dated July 28, 1997, and March 25, 1998. Firm-initiated recall ongoing. DISTRIBUTION Alabama, Arkansas, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Nevada, Oklahoma. QUANTITY 332 tubes of the CSLI label and 356 tubes of the Aularale label were distributed. REASON Products may be contaminated with Paecilomyces variotii. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II =========== _______________ PRODUCT Decadron Phosphate Injection (Dexamethasone Sodium Phosphate), 4 mg per mL in 1 mL and 2 mL vials, in boxes of 25 units, indicated for the treatment of multiple disorders, diseases or medical states. NDC # 0006-7628-66. Recall #D-118-8. CODE LOT NUMBERS: 1ml vials: Lots #'s 0307E (EXP. 1/00) and 0909E (EXP. 1/00) 2ml vials (distributed only internationally): Lot 0301B(EXP 3/98) Lot 0734B(EXP 5/98) Lot 0772B(EXP 7/98) Lot 0451E(EXP 6/99) Lot 1086D(EXP 6/99) Lot 1087D(EXP 6/99) Lot 0237B(EXP 2/98) Lot 0238B(EXP 2/98) Lot 1137D(EXP 6/99) Lot 0450E(EXP 7/99) Lot 0435E(EXP 8/99) Lot 0446E(EXP 3/00) Lot 0448E(EXP 3/00) Lot 0617E(EXP 4/00) Lot 1096E(EXP 9/00). MANUFACTURER Merck Manufacturing Division, Division of Merck & Company, Inc., West Point, Pennsylvania. RECALLED BY Manufacturer, by letter on January 21, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY Approximately 2,500 1-ml vials and an undetermined amount of 2-ml vials remained on market at time of recall initiation. REASON Precipitate/degradation. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ========== _______________ PRODUCT Fluocinonide Topical Solution USP, 0.05%, in 60 ml bottles, Rx for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses, under the Lemmon and Major labels. NDC #0093-0266-39 and #0904-0769-03. Recall #D-119-8. CODE Lot numbers: 6525 EXP 5/98, 6622 EXP 5/98. MANUFACTURER TEVA Pharmaceuticals USA, Inc., Sellersville, Pennsylvania. RECALLED BY Manufacturer, by letter dated January 28, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 500 bottles of lot 6525 under the Major label and 15,457 bottles under the Lemmon label and 15,963 bottles of lot 6622 under the Lemmon label were distributed. REASON Degradation/impurities leading to subpotency. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT Platelets. Recall #B-767-8. CODE Unit 81-13308. MANUFACTURER Michigan Community Blood Centers, Traverse City, Michigan. RECALLED BY Manufacturer, by telephone on June 20, 1997. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with Graves disease. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma, Frozen. Recall #B-876/878-8. CODE Unit numbers: a) 39F58065, 39F56749, 39G70442 b) 39F58065, 39F56749 c) 39F58065, 39F56749, 39G70442. MANUFACTURER American Red Cross Tri-State Region, Huntington, West Virginia. RECALLED BY Manufacturer, by letter dated February 18, 1998. Firm-initiated recall complete. DISTRIBUTION California, Kentucky, Ohio, West Virginia. QUANTITY a) 3 units; b) 2 units; c) 3 units were distributed. REASON Blood products were collected from a donor with a history of cancer. _______________ PRODUCT Red Blood Cells. Recall #B-918-8. CODE Unit #10529-8245. MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on August 21, 1997. Firm-initiated recall complete. DISTRIBUTION Arizona. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. _______________ PRODUCT Fresh Frozen Plasma. Recall #B-919-8. CODE Unit #10534-4577. MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on August 23, 1997. Firm-initiated recall complete. DISTRIBUTION Arizona. QUANTITY 1 unit was distributed. REASON Blood product corresponded to a unit of clotted red blood cells. _______________ PRODUCT Red Blood Cells. Recall #B-929-8. CODE Unit #22FT82854. MANUFACTURER American Red Cross Blood Services, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by telephone on September 2, 1997, and by letters dated September 9 and 15, 1997. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 unit was distributed. REASON Blood product was incorrectly tested for anti-CMV was distributed for transfusion. _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-952/953-8. CODE Unit numbers: a) 34-33611, 34-34338, 34-36637, 34-37480; b) 34-33611, 34-34338, 34-36637. MANUFACTURER Michigan Community Blood Centers, Saginaw, Michigan. RECALLED BY Manufacturer, by letter on December 9, 1997. Firm-initiated recall complete. DISTRIBUTION Michigan and Mississippi. QUANTITY a) 4 units; b) 3 units were distributed. REASON Blood products were collected from a donor with Graves disease. _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-954/955-8. CODE Unit numbers: a) 34-33722, 34-34415, 34-35177, 34-35890, 34-36594, 34-37284 b) 34-33722, 34-34415, 34-35177, 34-35890, 34-36594. MANUFACTURER Michigan Community Blood Centers, Saginaw, Michigan. RECALLED BY Manufacturer, by letter on October 17, 1997. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY a) 6 units; b) 5 units were distributed. REASON Blood products were collected from a donor with Graves disease. _______________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c) Red Blood Cells for further manufacture d) Recovered Plasma. Recall #B-961/964-8. 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, Galesburg, Illinois. RECALLED BY American Red Cross Blood Services, Peoria, Illinois, by letters dated September 1, 1997, October 1, 1997, February 5, 1998 or March 10, 1998, and October 24, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois, Iowa, Michigan, Massachusetts, Mississippi, California, Switzerland. QUANTITY a) 19 units; b) 1 unit; c) 2 units; d) 20 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 initially reactive for anti-HIV-1, with no duplicate retesting. _______________ PRODUCT a) Whole Blood; b) Red Blood Cells c) Platelets; d) Plasma e) Source Leukocytes f) Platelets, for further manufacturing g) Recovered Plasma. Recall #B-970/976-8. 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, Baltimore, Maryland. RECALLED BY Manufacturer, by telephone on January 16, 1998, or by letter dated January 12 or 29, 1998, by fax on February 18, 1998, and March 11, 1998. Firm-initiated recall ongoing. DISTRIBUTION Maryland, Pennsylvania, District of Columbia, Massachusetts, New Jersey, California. QUANTITY a) 1 unit; b) 36 units; c) 23 units; d) 8 units; e) 8 units; f) 2 units; g) 27 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) Platelets; c) Fresh Frozen Plasma, for further manufacture. Recall #B-994/996-8. CODE Unit #11N25297. MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri. RECALLED BY Manufacturer, by telephone on March 25, 1997, and on April 2, 1997. Firm-initiated recall complete. DISTRIBUTION Missouri, Alabama, California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor whose spouse has hepatitis C. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-997/998-8. CODE Unit 11H70853. MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri. RECALLED BY Manufacturer, by telephone on October 9 and 14, 1997. Firm-initiated recall complete. DISTRIBUTION Missouri and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had been deferred for high risk behavior. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Cryoprecipitate; d) Plasma; e) Fresh Frozen Plasma; f) Whole Blood; g) Recovered Plasma. Recall #B-1001/1007-8. 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, Cleveland, Ohio. RECALLED BY Manufacturer, by telephone on November 17, 1996, and by letters on one of the following dates: 1/15/97, 1/27/97, 1/30/97, 2/4/97, 2/10/97, 2/11/97, 2/12/97, 2/19/97, 2/20/97, 2/21/97, 2/24/97, 2/27/97, 2/29/97, 4/2/97. 4/14/97, 4/23/97, 7/9/97, or 7/24/97. Twenty seven non-responding consignees were sent second recall notices on either 3/17/97, 3/18/97, 3/19/97, 4/25/97, 5/27/97, 6/2/97 or 8/19/97. Firm-initiated recall complete. DISTRIBUTION Ohio, Georgia, Connecticut, Nebraska, California, Florida, Massachusetts, New York, Switzerland. QUANTITY a) 121 units; b) 59 units; c) 12 units; d) 59 units; e) 13 units; f) 8 units; g) 109 units were distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (HIV-1), but were collected from donors who previously tested repeatedly reactive for the antibody, and were improperly re-entered. _______________ PRODUCT Platelets. Recall #B-1016-8. CODE Unit #10531-1475. MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on December 8, 1997. Firm-initiated recall complete. DISTRIBUTION Arizona. QUANTITY 1 unit was distributed. REASON Blood product with visible aggregates was not quarantined and was distributed for transfusion. _______________ PRODUCT Platelets. Recall B-1017-8. CODE Unit #10581-2627. MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on February 10, 1998. Firm-initiated recall complete. DISTRIBUTION Arizona. QUANTITY 1 unit was distributed. REASON Blood product had an inadequate rest time during preparation. _______________ PRODUCT Platelets. Recall #B-1018-8. CODE Unit #10578-4312. MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on January 18, 1998. Firm-initiated recall complete. DISTRIBUTION Arizona. QUANTITY 1 unit were distributed. REASON Blood product had an inadequate rest time during preparation. _______________ PRODUCT Red Blood Cells. Recall #B-1044-8. CODE Unit #11LX51668. MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri. RECALLED BY Manufacturer, by telephone on November 4, 1997, and by letter on November 5, 1997. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 unit was distributed. REASON Blood product was not quarantined after receiving information concerning post donation illness. _______________ UPDATE Recall #B-856/857-8, Red Blood Cells and Platelets, recalled by Michigan Community Blood Centers, which appeared in the April 8, 1998 Enforcement Report should read: CODE: Unit #34-34277. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT Whole Blood. Recall #B-617-8. CODE Unit #21X74322. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by telephone on November 21, 1997. Firm-initiated recall complete. DISTRIBUTION Oregon. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who subsequently reported a post donation infection, was distributed after receipt of the information. _______________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall #B-949-8. CODE Unit numbers: 0492767, 0491431, 0491454, 0493502, 0491327, 0490823, 0490825, 0490822, 0491322, 0491323, 0490829. MANUFACTURER Bergen Community Regional Blood Center, Paramus, New Jersey. RECALLED BY Manufacturer, by telephone on October 23, 1995. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 11 units were distributed. REASON Unlicensed blood product was distributed in interstate commerce. _______________ PRODUCT Red Blood Cells. Recall #B-1008-8. CODE Unit numbers: 24KK75899 and 24KL19126. MANUFACTURER American Red Cross Blood Services, Louisville, Kentucky. RECALLED BY Manufacturer, by letter dated November 26, 1997. Firm-initiated recall complete. DISTRIBUTION Indiana and Kentucky. QUANTITY 2 units were distributed. REASON Blood products were stored at unacceptable temperatures. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Liebel-Flarsheim brand CT9000 Contrast Media Injectors, Catalog #800001, used to infuse known quantities of radiopaque contrast medium at a predetermined rate into a patient's vascular system which enhances diagnostic images obtained with Computed Tomography (CT). Recall #Z-529-8. CODE All units distributed since December 1992. The serial numbers for the first and last units manufactured are: 1292-0100 and 1197-2589, respectively. MANUFACTURER Liebel-Flarsheim Company, Cincinnati, Ohio. RECALLED BY Manufacturer, by letter on March 26, 1998, followed by telephone beginning on April 16, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 2,405 units were distributed. REASON The screw in the injector's pivot assembly, which holds the powerhead, may become loose or break and result in the powerhead falling down onto an individual standing directly under or nearby the falling component. _______________ PRODUCT Genzyme SaphLITE Products, a sterile, disposable device that is intended for use with the SaphLITE Saphenous Vein Retractor. These components, together with the light source and fiberoptic light cable, make up the Saphenous Vein System which is intended as a less invasive means to harvest the saphenous vein: a) SaphLITE Saphenous Vein Retractor, Part #89-2710; b) SaphLITE Fiberoptic Light Panel, Part #89-2711. Recall #Z-530/531-8. CODE Light Panel - 89-2711 and Retractor - 89-2710. MANUFACTURER Genzyme Surgical Products, Tucker, Georgia. RECALLED BY Manufacturer, by telephone and letter on March 13, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY a) 52 units; b) 654 units were distributed. REASON If the light panel is placed in direct contact with a secondary surface, the optical properties of the light panel may change, causing heat transfer to occur which may be excessive and present a risk of burn to the user or patient. _______________ PRODUCT Organon Teknika MDA-180 Coagulation Analyzer Version B Software, Part #22518-21, Revision #10.Q06.03. Recall #Z-525-8. CODE None. MANUFACTURER Organon Teknika Corporation, Oklahoma City, Oklahoma RECALLED BY Manufacturer, by letter on March 25, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 209 units were distributed. REASON This version of the software contains an error in a data file that controls the washing cycle which may cause carry-over from the previous test. _______________ PRODUCT Sysmex CA-6000 Automated Coagulation Analyzer, a fully automated, computerized blood plasma coagulation analyzer for in-vitro diagnostic use in clinical labs: a) Catalog No. B4260-6200, Chromogenic instrument; b) Catalog No. B4260-6300, Chromogenic upgrade kit. Recall #Z-527/528-8. CODE All serial numbers. MANUFACTURER TOA Medical Electronics, Company, Ltd., Kobe, Japan. RECALLED BY Dade Behring, Inc., Miami, Florida, by telephone on March 20, 1998, followed by letter on March 30, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Colombia, Mexico, Peru, Canada. QUANTITY 118 devices were distributed. REASON Carry-over of the Antithrombin III Substrate Reagent with testing when using the random access mode may result in falsely low sample values. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT COBAS INTEGRA Ion-Selective Electrode for Chloride, designed for the quantitative determination of sodium, potassium chloride and lithium in serum and plasma, and of sodium, potassium and chloride in urine, Product Code No. 1046268. Recall #Z-526-8. CODE Lot Nos. 436 and 037. MANUFACTURER Roche Diagnostic Systems, Kaiseraugst, Switzerland. RECALLED BY Roche Diagnostic Systems, Somerville, New Jersey, by letter on March 31, 1997. Firm-initiated recall complete. DISTRIBUTION New Jersey, New York, Connecticut, Pennsylvania, North Carolina, Florida, Alabama, Kentucky, Ohio, Louisiana, Arkansas, Texas. QUANTITY a) 30 units; b) 10 units were distributed; firm estimates none remains on the market. REASON The device may give falsely elevated chloride values in samples containing salicylate. _______________ PRODUCT Rheumaton(TM) 2-Minute Hemagglutination Slide Test for the Determination of Rheumatoid Factor: a) Product No. 35D2, Test Kit Size - 20 Tests; b) Product No. 35D4, Test Kit Size - 50 Tests; c) Product No. 35D6, Test Kit Size - 150 Tests. Recall #Z-532/534-8. CODE Lot numbers: a) 5HG1702, 5HG3102, and 5HH1001; b) 5HH0301, 5HH0902, 5HH1002, 5HH1101, and 5HH1601; c) 5HG1407, 5HG1701, and 5HH1603. MANUFACTURER Wampole Laboratories, Cranbury, New Jersey (own label distributor). RECALLED BY Carter Wallace, Inc., Cranbury, New Jersey, by telephone starting March 21, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY Lot # Amount Shipped 5HG1407 116 (150 tests per kit) 5HG1701 428 (150 tests per kit) 5HG1702 325 (20 tests per kit) 5HG3102 429 (20 tests per kit) 5HH0301 299 (50 tests per kit) 5HH0902 406 (50 tests per kit) 5HH1001 110 (foreign consignment) 5HH1002 597 (foreign consignment) 5HH1101 649 (50 tests per kit) 5HH1601 339 (50 tests per kit) 5HH1603 299 (150 tests per kit). Firm estimates none remain on the market. REASON Low amboceptor concentrations in the Rheumaton reagent can result in reduced test sensitivity. _______________ PRODUCT Zimmer F/M Acetabular Shell, 50 mm, indicated for use in surgery for rehabilitating hip damaged as a result of a variety of disease processes. Recall #Z-535-8. CODE Lot #12835500. MANUFACTURER Zimmer, Inc., Warsaw, Indiana. RECALLED BY Manufacturer, by letter on January 21, 1998, and by E-mail on March 4, 1998. Firm-initiated recall complete. DISTRIBUTION Texas, Tennessee, France, Italy, Japan, Greece, Germany, The United Kingdom. QUANTITY 33 units were distributed. REASON An incorrect size is etched onto the inside of the shell. The shell is actually 50 mm, but 52 mm is etched onto the shell. The carton label and the interior patient record label bear the correct size indication. _______________ PRODUCT Versy Beaded Full Coat Stem Hip Prosthesis: a) Catalog No. 00-7843-012-08; b) Catalog No. 00-7843-013-08; c) Catalog No. 00-7843-014-08; d) Catalog No. 00-7843-015-08; e) Catalog No. 00-7843-016-08; f) Catalog No. 00-7843-017-08; g) Catalog No. 00-7843-018-08; h) Catalog No. 00-7843-020-08. Recall #Z-536/543-8. CODE All lots. MANUFACTURER Zimmer, Inc., Warsaw, Indiana. RECALLED BY Manufacturer, by E-mail and certified mail on February 4, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Canada, England, Japan. QUANTITY 424 units were distributed. REASON Adhesive from pressure sensitive tape used during manufacturer adhered to the device, contaminating the device. _______________ UPDATE Recall #Z-522/524-8 which appeared in the April 29, 1998, Enforcement Report should be replaced with the following: PRODUCT Rheumaton(TM) 2-minute Hemagglutination Slide Test for the quantitative and qualitative determination of rheumatoid factor in serum or synovial fluid: a) Product #35D2, Test Kit Size - 20 Tests b) Product #35D4, Test Kit Size - 50 Tests, c) Product #35D6, Test Kit Size - 150 Tests. Recall #Z-522/524-8. CODE Lot Numbers: a) 3G7233D; b) 3G7233A and 3G7233E c) 3G7233 and 3G7233Z. MANUFACTURER Wampole Laboratories, Cranbury, New Jersey (own label distributor). RECALLED BY Carter-Wallace, Inc., Cranbury, New Jersey (responsible firm),by telephone starting February 7, 1995. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY Lot # Amount Shipped 3G7233 623 (150 tests per kit) 3G7233A 4427 (50 tests per kit) 3G7233D 180 (foreign consignment) 3G7233E 175 (foreign consignment) 3G7233Z 846 (150 tests per kit) REASON Low amboceptor concentrations in the Rheumaton Reagent can result in reduced test sensitivity. END OF ENFORCEMENT REPORT FOR MAY 6, 1998. BLANK PAGES MAY FOLLOW. ####