March 11, 1998 98-10 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ============ _______________ PRODUCT Thin Saltine Crackers under the Cracker Shoppe label, in 16 ounce cardboard cartons. Recall #F-277-8. CODE The cartons are branded with the following "BEST WHEN PURCHASED BY" codes: "0039 JUN07 98 3W", "0039 JUN 08 98 1W", "0039 JUN 08 98 2W", and "0039 JUN 08 98 3W". MANUFACTURER Wortz, Poteau, Oklahoma. RECALLED BY Bremmer, Inc., Princeton, Kentucky, by press release on February 11, 1998. Firm-initiated recall ongoing. DISTRIBUTION Kansas, Ohio, Pennsylvania. QUANTITY 315 display units (152,460 cartons) were distributed. REASON Product may contain pieces of metal. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III =========== _______________ PRODUCT Nestle Magic. Recall #F-278-8. CODE All codes. MANUFACTURER Whetstone Candy Company, St. Augustine, Florida. RECALLED BY Nestle USA, Inc., Glendale, California, by bulletin on October 2, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY Undetermined. REASON Product is adulterated under section 402(d)(1) of the Food, Drug, and Cosmetic Act in that it contains a nonnutritive foreign object. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ============ _______________ PRODUCT Aloe Vesta Protective Ointment, in 2 and 8 ounce tubes, OTC, used as a barrier from external moisture. Recall #D-097-8. CODE Lot numbers 04D7 (2 oz & 8 oz), 05D7 (8 oz), 22D7 (8 oz). MANUFACTURER Kutol Products Company, Cincinnati, Ohio (contract manufacturer) RECALLED BY ConvaTec, a Bristol-Myers Squibb Company, Skillman, New Jersey, by letter on June 27, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide and Canada. QUANTITY Amounts sold: Lot 04D7 (2 oz.) 581 cases (13,944 tubes) Lot 04D7 (8 oz.) 38 cases (456 tubes) Lot 05D7 (8 oz.) 316 cases (3,792 tubes) Lot 22D7 (8 oz.) 62 cases (744 tubes). REASON Microbial contamination (Pseudomonas putida). RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III =========== _______________ PRODUCT Promotional literature for Natural efx OTC moisturizing creams and dietary supplements in product information sheets contained in Distributor Kits and in company brochures: a) Women's Wild Yam efx Moisturizing Skin Cream in 2 ounce jars; b) Men's Wild Yam efx Moisturizing Skin Cream in 2 ounce jars; c) Body Balancing 3, 360 mg Capsules, 90 capsules per bottle d) Body Balancing 4, 500 mg Capsules, 90 capsules per bottle e) Body Balancing 2, 500 mg Capsules, 90 capsules per bottle f) Body Balancing 1, 500 mg Capsules, 90 capsules per bottle g) Lipo efx, 500 mg Capsules, 90 capsules per bottle h) Plant efx, 220 mg Capsules, 90 capsules per bottle I) Gas efx, 360 mg Capsules, 90 capsules per bottle j) Oxy efx, 235 mg Capsules, 90 capsules per bottle k) Digest efx, 220 mg Capsules, 90 capsules per bottle l) Cleanz efx, 370 Capsules, 90 capsules per bottle. Recall #D-085/096-8. CODE Uncoded. All promotional labeling distributed prior to May 1997. MANUFACTURER Natural efx, Inc., Richardson, Texas. RECALLED BY Manufacturer, by providing revised manuals to distributors who renewed their annual registration fees in November 1996 through April 1997, and by letter dated May 19, 1997. Firm-initiated field correction complete. DISTRIBUTION Nationwide. QUANTITY Product information sheets that made false and misleading medical claims were included in approximately 6,000 Distributor Kits distributed between January and October 1996. REASON Misbranding - Unapproved drug claims. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======== _______________ PRODUCT a) Red Blood Cells; b) Platelets C) Fresh Frozen Plasma; d) Recovered Plasma. Recall #B-587/590-8. CODE Unit numbers: a) 6088420, 6088423, 6088427 b) 6088420, 6088423, 6088427 c) 6088420, 6088423, 6088427; d) 6088420. MANUFACTURER The Mount Sinai Medical Center, New York, New York. RECALLED BY Manufacturer, by telephone on November 10, 1997, and by letters on October 21, 1997, and November 10, 1997. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY a) 3 units; b) 3 units; c) 3 units; d) 1 unit was distributed. REASON Blood products tested repeat reactive for the antibody to the Hepatitis B surface antigen (HBsAg) with no confirmatory test. _______________ PRODUCT Platelets, pheresis. Recall #B-591-8. CODE Unit numbers: 7020428, 7020432, 7020438. MANUFACTURER South Texas Blood & Tissue Center, San Antonio, Texas. RECALLED BY Manufacturer, by letter dated December 16, 1996. Firm-initiated recall ongoing. DISTRIBUTION Texas. QUANTITY 3 units were distributed. REASON Blood components were filtered with an unapproved (unlicensed) disposable set. _______________ PRODUCT Platelets-Pheresis, Leukocytes Reduced. Recall #B-592-8. CODE Unit numbers: 7019212, 7019213. MANUFACTURER South Texas Blood and Tissue Center, San Antonio, Texas. RECALLED BY Manufacturer, by telephone on May 14, 1996. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 2 units were distributed. REASON Blood products were labeled with an extended expiration date. _______________ PRODUCT Source Plasma. Recall #B-600-8. CODE Unit numbers: 84416520, 84415905, 84411983, 84411099. MANUFACTURER Bio-Blood Components, Inc., Columbus, Ohio. RECALLED BY Manufacturer, by letter dated July 24, 1997. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 4 units were distributed. REASON Blood products tested negative for viral markers were collected from a donor who was deferred at another center due to unsuitable HIV test results, and were distributed after receipt of this information. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-601/603-8. CODE Unit #03GN07576. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by telephone on February 1 and 2, 1996, followed by letter dated February 21, 1996. Firm-initiated recall complete. DISTRIBUTION Georgia and Florida. QUANTITY 1 unit of each component was distributed. REASON Blood products tested positive for syphilis. _______________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-620/621-8. CODE Unit #1164873. MANUFACTURER Carter Blood Center, Fort Worth, Texas. RECALLED BY Manufacturer, by letter dated November 25, 1997. Firm-initiated recall complete. DISTRIBUTION Texas and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were drawn from an unsuitable donor. _______________ PRODUCT Platelets, Pheresis. Recall #B-629-8. CODE Unit #03P91614. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by telephone on January 19, 1996. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 1 unit was distributed. REASON Blood product with a residual white blood cell count that exceeded the acceptable value was distributed labeled as leukoreduced. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Buffy Coat. Recall #B-636/638-8. CODE Unit #18FQ25959. MANUFACTURER American Red Cross Great Lakes Region, Lansing, Michigan. RECALLED BY Manufacturer, by letter dated November 18, 1997. Firm-initiated recall complete. DISTRIBUTION Michigan and New Jersey. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected in a manner that may have compromised the sterility of the units. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Cryoprecipitated AHF. Recall #B-639/641-8. Code Unit #18FE44524. MANUFACTURER American Red Cross Great Lakes Region, Lansing, Michigan. RECALLED BY Manufacturer, by letter dated November 10, 1997. And by telephone on November 18, 1997. Firm-initiated recall complete. DISTRIBUTION Michigan and Ohio. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected in a manner that may have compromised the sterility of the units. _______________ PRODUCT Platelets, Pheresis. Recall #B-642-8. CODE Unit #16KF12186. MANUFACTURER American Red Cross, Columbus, Ohio. RECALLED BY Manufacturer, by letter dated October 29, 1997. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit was distributed. REASON Blood product was inappropriately prepared by recording the incorrect volume on the label which resulted in the product being distributed in one platelet bag instead of two. _______________ PRODUCT Red Blood Cells. Recall #B-643-8. CODE Unit 4594294. MANUFACTURER National Naval Medical Center, Bethesda, Maryland. RECALLED BY Manufacturer, by telephone on September 4, 1997. Firm-initiated recall complete. DISTRIBUTION New Jersey and Texas. 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 HNA Classic Blood Bank Transfusion Computer Software Program: a) PathNet Blood Bank Transfusion (L-2300), Release #302-306 b) PathNet Worksystems (L-2812), Release #306 c) PathNet Blood Center (L-2510), Release #306. Recall #B-650-8. CODE Release #306. MANUFACTURER Cerner Corporation, Kansas City, Missouri. RECALLED BY Manufacturer, by telephone on February 20, 1998, and by letter dated February 23, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 308 software packages were distributed. REASON Intended warning messages alerting the user to the potential release of ABO Rh incompatible units did not appear when using the "Dispense Products" function for emergency release. _______________ PRODUCT Fresh Frozen Plasma. Recall #B-651-8. CODE Unit #4764980. MANUFACTURER National Naval Medical Center, Bethesda, Maryland. RECALLED BY Manufacturer, by telephone on or about February 5, 1997. Firm-initiated recall complete. DISTRIBUTION District of Columbia. QUANTITY 1 unit was distributed. REASON Blood product was not tested for the antigen to the human immunodeficiency virus type 1 antigen (HIV-1 Ag). _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-662/664-8. CODE Unit #53J95647. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letters dated December 17 and 23, 1997. Firm-initiated recall complete. DISTRIBUTION Maryland and California. 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. _______________ PRODUCT a) Red Blood Cells; b) Platelets c) Fresh Frozen Plasma d) Cryoprecipitated AHF e) Platelets, for further manufacture f) Recovered Plasma. Recall #B-665/670-8. CODE Unit numbers: a) 21F19765, 21F37319, 21F48655, 21F67965, 21F72235, 21M95379, 21S10595, 21GH46432, 21GM20340 b) 21F37319, 21F48655, 21F72235 c) 21F19765, 21F37319 d) 21GM20340, included in pool 21E06595 e) 21S10595 f) 21F48655, 21F67965, 21F72235, 21M95379, 21S10595, 21S53250, 21GH46432, 21GM20340. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by telephone on July 1, 1997, followed by letter on August 4, 1997, and on October 4, 1997. Firm-initiated recall complete. DISTRIBUTION Oregon, Washington state, Kansas, California. QUANTITY a) 9 units; b) 3 units; c) 2 units; d) 1 unit; e) 1 unit; f) 8 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. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT Platelets. Recall #B-596-8. CODE Unit numbers: 49GF05480, 49GF05498, 49GF05508, 49S74704, 49X52909, 49Y45713. MANUFACTURER American Red Cross Blood Services, Wichita Falls, Texas. RECALLED BY Manufacturer, by telephone on November 18, 1997, and by letter dated December 9, 1997. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 6 units were distributed. REASON Blood products were exposed to unacceptable shipping temperatures. _______________ PRODUCT Source Plasma. Recall #B-599-8. CODE Unit numbers: 86040150, 86040167, 86040174, 86040181, 86040198, 86040204, 86040211, 86040228, 86040235, 86040242, 86040259, 86040266. MANUFACTURER Bio-Blood Components, Inc., Columbus, Ohio. RECALLED BY Manufacturer, by telephone on May 30, 1997. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 12 units were distributed. REASON Blood products were untested for viral markers. _______________ PRODUCT Red Blood Cells. Recall #B-604-8. CODE Unit numbers 03GF24809 and 03GN04776. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by telephone on May 30, 1995, followed by letter dated June 1, 1995. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 2 units were distributed. REASON Blood products were labeled with extended expiration dates. _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-623/624-8. CODE Unit numbers: 6702690 and 2726331. MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana. RECALLED BY Manufacturer, by telephone on either October 13 or 24, 1997, and by letter dated November 8, 1997. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 2 units of each component were distributed. REASON Blood products had extended expiration dates. _______________ PRODUCT Platelets, Pheresis. Recall #B-630-8. CODE Unit #03FG11925. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by telephone on May 19, 1997. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 1 unit was distributed. REASON Blood product was crossmatch incompatible was labeled as compatible. _______________ PRODUCT Platelets, Pheresis. Recall #B-634-8. CODE 03P84439, 03P84712, 03P85903. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by letter dated June 26, 1995. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 3 units were distributed. REASON Blood products were collected by apheresis at an unacceptable temperature. _______________ PRODUCT Red Blood Cells. Recall #B-635-8. CODE Unit numbers: 03GV00716, 03GV00664, 03GR09869, 03GS06832, 03GJ22027, and 03GV00380. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by letter dated July 5, 1995. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 6 units were distributed. REASON Blood products may have been labeled with extended expiration dates. _______________ PRODUCT Red Blood Cells. Recall #B-644-8. CODE Unit numbers: 18S66777, 18FC90164, 18FQ19916, 18FQ20673, 18FS09518, 18GG13095, 18GH21961, 18GJ14960, 18Q95729, 18Q95842, 18S66730. MANUFACTURER American Red Cross, Fort Wayne, Indiana. RECALLED BY Manufacturer, by letters on August 25 and 27, 1997, and September 4, 1997. Firm-initiated recall complete. DISTRIBUTION Indiana, Michigan, Ohio. QUANTITY 11 units were distributed. REASON Blood products were exposed to unacceptable shipping temperatures. _______________ PRODUCT Red Blood Cells, Irradiated. Recall #B-656-8. CODE Unit #40FQ24234. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by telephone on November 24, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Zoll Autoclaveable Internal Handles, Catalog #8004-0023, intended for use in conjunction with Zoll's 1400/2000 Series Defibrillators to defibrillate the heart during open chest surgical procedures. Recall #Z-038-8. CODE Serial numbers: N97F00978-N97F00979; N97F00981-NP97F00999; N9701000-N97F01004; N97F01009; N97F01011, N97F01014-N97F01020; N97F01052-N970F01060. MANUFACTURER Zoll Medical Corporation, Burlington, Massachusetts. RECALLED BY Manufacturer, by telephone on July 7 and 8, 1997. Firm-initiated recall ongoing. DISTRIBUTION Alabama, Alaska, Louisiana, Kansas, Tennessee, Washington state. QUANTITY 42 units were distributed. REASON Lack of energy delivery to patient. _______________ PRODUCT Futura Instrument Software for APTT Application, an automated random access analyzer for in-vitro diagnostic use in coagulation and fibrinolysis testing in human plasma: ACL Futura System, Model Numbers: a) 0290001, ACL Futura (115 w/Barcode) b) 0290011, ACL Futura (220 w/Barcode) c) 0290111, ACL Futura (220 w/o Barcode) d) 0290006, ACL Futura (Japanese w/Barcode) 0290021, ACL Futura (220V/barcode w/o comp) 0029101 (models with various power supply, voltage and barcode options). Recall #Z-213/218-8. CODE Software versions prior to version 3.1. MANUFACTURER Instrumentation Laboratory Company, Lexington, Massachusetts. RECALLED BY Manufacturer, by letter May 19, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 584 units were distributed. REASON Software Problem caused false Short APTT (Activated Partial Thromboplastin Time). _______________ PRODUCT DC Medical Correct-A-Count Needle Count and Sharps Disposal System, foam strip needle counter products: a) Sterile Products with the Catalog Numbers: 20-0301 20-0302 20-0303 20-0401 20-0402 20-0701 20-0702 20-0102; b) Non-Sterile Products with the Catalog Numbers: 20-4301 20-4302 20-4303 20-4305 20-4306 20-4401 20-4402 20-4701 20-4702 20-4103 20-4104. Recall #Z-331/332-8. CODE All lot date numbers between 01/01/97 and 05/31/97 identified with the above catalog numbers. MANUFACTURER PSC, Inc., Louisville, Kentucky (component). RECALLED BY DC Medical, Division of PSC Corporation, Louisville, Kentucky, by telephone , followed by letter dated June 20, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 1,990 cases (191,040 units) were distributed. REASON The foam strip delaminated from the plastic box causing possible needle stick injury to a health care professional. _______________ PRODUCT Siemens Servo Ventilator 300/300A, designed for intensive care ventilation. Recall #Z-357-8. CODE Serial numbers 6175-10499. Fuses, Siemens Part #61 89 7 52. MANUFACTURER Siemens-Elema AG, Solna, Sweden. RECALLED BY Siemens Medical Systems, Inc., Electromedical Systems Group, Danvers, Massachusetts, by letter on December 29, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 1,528 units were distributed. REASON Premature failure of fuse which could cause loss of power to the ventilator. _______________ PRODUCT MCA and NOVA brand Hemodialyzers, a disposable device used for hemodialysis: a) MCA200, Catalog No. 201-855 b) Altra Nova200, Catalog No. 211-484G. Recall #Z-358/359-8. CODE Lot Numbers: a) 855970526A, 855970815A, 855970821; b) 484970427B. MANUFACTURER Althin Medical, Inc., Miami Lakes, Florida. RECALLED BY Manufacturer, by letter on December 22, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Sweden QUANTITY 9,706 units were distributed. REASON The hemodialyzer headers may become lose. _______________ PRODUCT Model Series Luxura 48, Sunlamp Tanning Products. Model Luxura 48. MANUFACTURER ProSun Tanning Industries, Inc., doing business as Hapro, St. Petersburg, Florida. RECALLED BY Manufacturer. FDA approved the firm's corrective action plan on February 12, 1998. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY 95 units were distributed. REASON The sunlamp product failed to comply with 21 CFR 1040.20(d)(1)(iv) because the products failed to include an adequate recommended exposure schedule. _______________ PRODUCT Sunlamp tanning products: a) Model Maximultysun; b) Model No. T180; c) Model No. T200; d) Model Kombi; e) Model Tristar 4000; f) Model Compact 4000; g) Model Ringo. Recall #Z-363/369-8. CODE None. MANUFACTURER Helios Technologies, Inc., Aurora, Illinois. RECALLED BY Manufacturer. FDA approved the firm's corrective action plan on February 19, 1998. Firm-initiated field correction ongoing. DISTRIBUTI 82 units were distributed. REASON The sunlamp products imported by Helios Technologies Incorporated failed to comply with the warning label and user instruction requirements of the sunlamp performance standard (21 CFR 1040.20). _______________ PRODUCT Knightstar 320 bi-level respiratory system for the support of spontaneously breathing patients a) Model No. 320I/E, Serial Nos. 704230000 and higher on units delivered in 1997; b) Model No. 320B, Serial Nos. 704252000 through 706192050; on units delivered in 1997. c) Model No. 335, Serial Nos. 704040000 and higher Recall #Z-375/377-8. CODE a) Serial Nos. 704230000 through 711300000 b) Serial Nos. 704252000 through 706192050 c) Serial Nos. 704040000 through 711300000. MANUFACTURER Nellcor Puritan Bennett, Inc., Lenexa, Kansas. RECALLED BY Nellcor Puritan Bennett, Inc., Minneapolis, Minnesota, by letter February 13, 1998. Firm-initiated recall ongoing DISTRIBUTION Nationwide and international. QUANTITY 2,968 units were distributed. REASON Some of the devices are delivering air pressures that are not the same as the device settings. The deviations have been positive or above the pressure settings. _______________ PRODUCT Becker External Drainage and Monitoring System with Anti-Reflux Valve, used to provide the physician with a closed system for draining cerbrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space for monitoring CSF pressure and flow. Recall #Z-380-8. CODE Catalog #25120, Lot numbers: 0672A EXP 2/28/02, 1186A Exp 5/30/02, 1299A EXP 6/30/02, 1477A EXP 7/30/02, 1478 EXP 8/30/02. MANUFACTURER Medtronic PS Medical, Goleta, California. RECALLED BY Manufacturer, by telephone or by visit beginning on or about January 16, 1998. Firm-initiated recall ongoing. DISTRIBUTION California, New Jersey, Virginia. QUANTITY 39 units were distributed. REASON A drawing error was discovered where the depiction of the anti-reflux valve was inverted when compared to the previous drawing revision. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT AIM Supracondylar Nail, Part #1812-20, indicated for fracture fixation of the distal third of the femur. Recall #Z-362-8. CODE Lot #RY3647. MANUFACTURER Depuy Ace Medical Company, El Segundo, California. RECALLED BY Manufacturer, by telephone on January 14, 1998, followed by letter dated January 15, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 50 nails were distributed. REASON The cannula running through the complete length of the nail was omitted during manufacture. __________ AngioJet F105 Rapid Thrombectomy Catheters labeled as being AngioJet LF140 Rapid Thrombectomy Catheters, sterile, single-use, 5 French, peripheral, vascular catheters. Recall #Z-378-8. CODE Lot 11667. MANUFACTURER Possis Medical, Inc., Minneapolis, Minnesota. RECALLED BY Manufacturer, by telephone on August 12, 1997. Firm-initiated recall complete. DISTRIBUTION California, Illinois, Kentucky, Massachusetts, Michigan, South Carolina, Tennessee, Wisconsin. QUANTITY 16 catheters were distributed. REASON Device is mislabeled as to length. _______________ PRODUCT dsDNA IgG/M Enzyme-Linked Immunosorbent Assay (ELISA), Wampole Laboratories Product No. 427670 (Clark Laboratories Product No. 2327670), for in-vitro diagnostic use. Recall #Z-379-8. CODE Lot No. 042. MANUFACTURER Trinity Biotech, Jamestown, New York. RECALLED BY Manufacturer, by letter dated February 3, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 277 kits were distributed. REASON Index value of the positive control is above its stated range on the vial label. _______________ PRODUCT Various Enzyme Immunoassays (EIAs), in-vitro diagnostic products labeled with Bartels Inc.: a) Toxoplasma IgG EIA, Catalog No. B1029-310 b) Toxoplasma IgM EIA, Catalog No. B1029-315 c) Rubella IgG EIA, Catalog No. B1029-320 d) Rubella IgM EIA, Catalog No. B1029-325 e) Cytomegalovirus IgG EIA, Catalog No. B1029-330 f) Herpes Simplex Virus 1 IgG EIA, Catalog No. B1029-340 g) Epstein-Barr Virus, IgM EIA, Catalog No. B1029-365 h) Rubeola IgG EIA, Catalog No. B1029-380. Recall #Z-381/388-8. CODE Lot numbers: a) 2092; b) 2096; c) 2084 and 2087; d) 2098; e) 2095 f) 2099; g) 2093; 2083, 2091. MANUFACTURER Gull Laboratories, Inc., Salt Lake City, Utah. RECALLED BY Bartels, Inc., The Diagnostics Division of Intracel Corporationa, Issawuah, Washington, by letter dated January 9, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Canada, Ireland, Australia, Singapore. QUANTITY a) 41; b) 7; c) 100 of lot 2084, 34 of lot 2087, 1 of lot 7HMDSN d) 2; e) 10; f) 24; g) 4; h) 7; i) 99 j) 70 of lot 2083; 41 lot 2091 were distributed. REASON Products contain conjugate which may demonstrate decline in absorbance values over time. END OF ENFORCEMENT REPORT FOR MARCH 11, 1998. BLANK PAGES MAY FOLLOW.End of Enforcement Report for