March 5, 1997 97-10 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ========== _______________ PRODUCT RX Guiatuss with Codeine Syrup, in 1 gallon, 16 ounce, 8 ounce, and 4 ounce bottles, an expectorant, cough suppressant, under the following labels: Barre, Rugby, Schein, and H.L. Moore. Recall #D-120-7. CODE Lot numbers: RB6059, RA6016, RS5841, RP5742, RP5743, RN5652, RL5568, RK5512, RJ5429, RB5089, RA5028, RA5027. MANUFACTURER Alpharma (Barre-National), Baltimore, Maryland. RECALLED BY Manufacturer, by letter on January 14, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 1,563,288 units were distributed. REASON Product lacks stability (i.e. codeine phosphate analysis results showed decreasing potency). _______________ PRODUCT Sodium Acetate Injection, USP, 100 mEq, (2 mEq/ml), Preservative Free, in 50 ml single dose vials, for IV use only after dilution, as a source of sodium for addition to large volume IV fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. Recall #D-121-7. CODE Lot numbers: 150681 EXP 5/97, 160634 EXP 4/98. MANUFACTURER Fujisawa USA, Inc., Melrose Park, Illinois. RECALLED BY Fujisawa USA, Inc., Deerfield, Illinois, by letter dated February 11, 1997. Firm- initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 29,375 vials were distributed; firm estimated that 25 percent of the product remained on market at time of recall initiation. REASON Label error on declared strength (i.e. label incorrectly states "Each ml contains 272.16 mg sodium acetate" (anhydrous), it should read, "Each ml contains 164 mg sodium acetate (anhydrous). RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma. Recall #B-386/387-7. CODE Unit #40GT45514. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by telephone on July 23, 1996, followed by letter dated July 30, 1996. Firm- initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit of each component was distributed. REASON Blood products tested repeatedly reactive for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1). _______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-388/389-7. CODE Unit #40GL09293. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by telephone on July 23, 1996, followed by letter dated July 30, 1996. Firm- initiated recall complete. DISTRIBUTION Florida and California. QUANTITY 1 unit of each component was distributed. REASON Blood products tested repeatedly reactive for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1). _______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-390/391-7. CODE Unit #40GT45575. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by telephone on July 23, 1996, followed by letter dated July 30, 1996. Firm- initiated recall complete. DISTRIBUTION Illinois and California. QUANTITY 1 unit of each component was distributed. REASON Blood products tested repeatedly reactive for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1). _______________ PRODUCT Red Blood Cells. Recall #B-416-7. CODE Unit numbers: S54405, S56115, S56761, S49163, S55063. MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois. RECALLED BY Manufacturer, by telephone on January 5, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 5 units were distributed. REASON Blood products were stored at an unacceptable temperature. _______________ PRODUCT Red Blood Cells. Recall #B-409-7. CODE Unit numbers: 4004474, 1681268, 3010521, 3500779, 6007126, 7414729, 8007064, 4008128, 2000304, 1031016, 5023984, 7153469, 5009721, 4007348. MANUFACTURER LifeSource Blood Services, Glenview, Illinois. RECALLED BY Manufacturer, by letter dated April 18, 1996. Firm-initiated recall complete. DISTRIBUTION California, Illinois, Kentucky, Ohio. QUANTITY 14 units were distributed. REASON Blood products were not tested for anti-HCV and no further testing was conducted on the donors. _______________ PRODUCT Red Blood Cells. Recall #B-417-7. CODE Unit #47T29763. MANUFACTURER American Red Cross Blood Services, Galesburg, Illinois. RECALLED BY American Red Cross Blood Services, Peoria, Illinois, by telephone on August 30, 1996, followed by letter. Firm-initiated recall complete. DISTRIBUTION Iowa. QUANTITY 1 unit was distributed. REASON Blood product tested repeatedly reactive for the antibody to the hepatitis B core antigen (anti-HBc). _______________ PRODUCT Platelets. Recall #B-418-7. CODE Unit #53F10114. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated October 28, 1996. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 unit was distributed. REASON Blood product was positive for anti-Kell and anti-Jsa antibodies was distributed and labeled as negative for unexpected antibodies. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma. Recall #B-423/425-7. CODE Unit #29045-5068. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by letter dated September 9, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit of each component was distributed. REASON Blood products tested initially reactive for the hepatitis B surface antigen (HBsAg), but had no repeat testing performed. _______________ PRODUCT Platelets. Recall #B-427-7. CODE Unit #53T32131. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated January 11, 1996. Firm-initiated recall complete. DISTRIBUTION District of Columbia. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of whole blood with an extended collection time. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-428/429-7. CODE Unit #53GN66133. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated October 10, 1995. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor who emigrated from a malarial endemic area within three years of donation. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-376/377-7. CODE Unit numbers: 2649385 and 4900157. MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana. RECALLED BY Manufacturer, by telephone on September 5-6, 1996, and by letter dated September 27, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 2 units of each component were distributed. REASON Blood products not quarantined and released despite the donor's use of confidential exclusion sticker. _______________ PRODUCT Recovered Plasma. Recall #B-382-7. CODE Unit #24124. MANUFACTURER Marshalltown Medical & Surgical Center, Marshalltown, Iowa. RECALLED BY Manufacturer, by telephone, fax, and by letter on November 10, 1994. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 unit was distributed. REASON Blood product was distributed prior to completion of testing and subsequently tested repeat reactive for anti-HBc. _______________ PRODUCT Fresh Frozen Plasma. Recall #B-415-7. CODE Unit numbers: 360052 364583 364818 365018 365066 365085 366376 366997 367010 367013 367016 367018 367767 368261 368573 368584 368590 368593 368598 368617 369730 369740 369749 369754 370993 371013 371273 371979 371982 371987 371995 372001 372011 372012 372014 372020 372021 372024 372025 372028 372238 372243 372246 373232 373716 380463 380488 380491 380493 380496 380498. MANUFACTURER Memorial Blood Centers of Minnesota, Minneapolis, Minnesota. RECALLED BY Manufacturer, by telephone on February 13, 1996. Firm-initiated recall complete. DISTRIBUTION Minnesota. QUANTITY 51 units were distributed. REASON Blood products were stored at temperatures exceeding acceptable limits. _______________ PRODUCT Red Blood Cells. Recall #B-419-7. CODE Unit numbers: 17179-9840 and 17179-9966. MANUFACTURER United Blood Services, McAllen, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on October 7, 1996. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 2 units were distributed. REASON Blood products may have been exposed to unacceptable temperatures. _______________ PRODUCT Red Blood Cells. Recall #B-420-7. CODE Unit numbers: 17179-8777, 17179-9747, 17180- 1248, 17180-1210, 17180-1048, 17180-0470. MANUFACTURER United Blood Services, McAllen, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on September 23, 1996. Firm- initiated recall complete. DISTRIBUTION Texas. QUANTITY 6 units were distributed. REASON Blood products may have been exposed to unacceptable temperatures. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-430/431-7. CODE (a) 0310131, 0310103, 0310147, 0310143; (b) 0310094, 0310098, 0310141. MANUFACTURER Community Blood Bank of Lancaster County Medical Society, Lincoln, Nebraska. RECALLED BY Manufacturer, by telephone on May 15, 1996. Firm-initiated recall complete. DISTRIBUTION Nebraska. QUANTITY (a) 4 units; (b) 3 units were distributed. REASON Blood products were incorrectly tested for the hepatitis B surface antigen (HBsAg). _______________ PRODUCT Whole Blood. Recall #B-453-7. CODE Unit #53GJ31002. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by telephone on October 23, 1995. Firm-initiated recall complete. DISTRIBUTION District of Columbia. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Adult Arterial Filters, indicated for use in cardiopulmonary bypass procedures for removal of particulate and gaseous micro emboli: (a) Model No. 20; (b) Model No. M-220; (c) Model No. M-40; (d) Model No. M-440; (e) Model No. CBM-20; (f) Model No. CBM-40. Recall #Z-287/292-7. CODE Lot Numbers: 0132407-1 and 032406-501. MANUFACTURER Medtronic Cardiopulmonary, Anaheim, California. RECALLED BY Manufacturer, by letter dated October 25, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 90,000 units were distributed. REASON Breakage at the arterial outlet port. _______________ PRODUCT Z-274/281-7, Royal Flush Plug Angiographic Catheters with Beacon Enhanced Radiopaque Tips, which appeared in the February 26, 1997, Enforcement Report should read: MANUFACTURER: Cook, Inc., Bloomington, Indiana. END OF ENFORCEMENT REPORT FOR MARCH 5, 1997. 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