October 4, 2000 00-40RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______ PRODUCT Jensen's Seattle Style Smoked Wild Pacific King Salmon, in clear vacuum pack pouch. Recall #F-862-0. CODE 000708, 000714, 000715. MANUFACTURER Jensen's Old Fashioned Smokehouse, Inc., Seattle, Washington. RECALLED BY Manufacturer, by press release on August 9, 2000, and by telephone. Firm-initiated recall complete. DISTRIBUTION Washington State. QUANTITY 270 pounds were distributed. REASON Product is contaminated with Listeria monocytogenes.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Oasis brand Eggplants in Brine, in 19-ounce metal cans. Recall #F-908-0. CODE All product on the market at the time of recall initiation. MANUFACTURER Kad Bnei Darom Food Products, Bnei-Darom D.N. Evtach, Israel. RECALLED BY Trans Mid-East Shipping & Trading Agency, Inc., Brooklyn, New York, by letter dated May 18, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, New Jersey, Florida, Massachusetts, Georgia, Texas. QUANTITY 60 cases (24 cans per case) were distributed. REASON Product contained the unapproved color additive carmosine. ________ PRODUCT a) Taco Bell Home Originals Taco Shells, packaged in boxes of 12, shells, Net Wt. 4.5 oz., UPC #28400-00417, and 18 shells, Net Wt. 6.75 oz., UPC #28400-00423; b) Taco Bell Home Originals Taco Dinner, 12 shells, sauce and seasoning, Net Wt. 10.75 oz., UPC #28400-01170 - 12 box case, UPC #28400-08132 - 4/3 pack case. Recall #F-912/913-0. CODE All product on the market at the time of recall initiation. MANUFACTURER Sabritas Mexicali, a wholly owned subsidiary of PepsiCo, Inc., Mexicali, Mexico. RECALLED BY Kraft Foods, Inc., Northfield, Illinois, by fax and E-mail and press release on September 22, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 635,991 cases were distributed. REASON Products appear to contain Bacillus thuringiensis subspecies tolworthi Cry9C protein and the genetic material necessary for its production in corn (trade name: StarLink)- a pesticide which is not allowed for use in foods.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT Welch's 100% Apple Juice, in 16-fluid ounce bottles. Recall #F-831-0. CODE Lot OV24G. MANUFACTURER Krier Foods, Inc., Random Lake, Wisconsin. RECALLED BY Welch's, Concord, Massachusetts, by telephone and letter on August 23, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 1,178 cases (24 bottles per case) were distributed. REASON Product is contaminated with mold. ________ PRODUCT a) Three Rivers brand Coconut Slice, in 7-ounce (200gm) flexible plastic packages; b) Three Rivers brand Coconut, in 7-ounce (200gm) flexible plastic packages. Recall #F-832/833-0. CODE None. REPACKER Shata Trading, Inc., Brooklyn, New York. RECALLED BY Repacker, by visit April 13, 2000. Completed field correction (relabeling) resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York and New Jersey. QUANTITY Approximately 100 cases (24 packages per case) were distributed. REASON Products contained undeclared sulfites.RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS I
________ PRODUCT Anti-Aging System Skin Renewing "C" Slices Vitamin C Eye Relief, treated eye pads in sealed packets of pairs. Recall #F-835-0. CODE No code printed on the product [manufacturer's lot code is UD001(0403/0405)]. MANUFACTURER Dermal Sciences, Inc., Fairfield, Connecticut. RECALLED BY Garden Botanika, Redmond, Washington, by letter on July 13, 2000, by telephone, and by press release on July 21, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 594 boxes (6 pairs per box) were distributed. REASON Product is contaminated with Ochrobactrum anthropi, Bacillus species, and Enterobacter gergoviae.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT Suprax Tablets, 400 mg, Rx, used to treat bacterial infections. NDC #51655-794-47. Recall #D-472-0. CODE Lot #S078RB EXP 1/31/00. MANUFACTURER Pharmaceutical Corporation of America, Carmel, Indiana. RECALLED BY Manufacturer, by telephone on May 11, 2000. Firm-initiated recall complete. DISTRIBUTION Wyoming. QUANTITY 56 bottles were distributed. REASON Label mix-up - Product bore a bar code for Cefadroxil.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT Fenwal Autopheresis-C Plasmapheresis System, Models A-200, A-201, and A- 401. Recall #B-860-0. CODE Product Code Numbers: 4R4550, 4R4560, 4R4561, R4R4585 MANUFACTURER Baxter Healthcare Corporation, Largo, Florida. SOFTWARE DEVELOPER Baxter Healthcare Corporation, Round Lake, Illinois. RECALLED BY Baxter Healthcare Corporation, Deerfield, Illinois, by telephone and fax dated May 5, 2000, followed by letter dated June 15, 2000. Firm- initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 5,250 units were distributed REASON The Autopheresis-C Plasmapheresis instruments with version 6.0 software may proceed to "Saline Rinse" without displaying the “Remove Plasma” prompt. ________ PRODUCT Source Plasma. Recall #B-938-0. CODE Unit Numbers: 17265546 and 1726358. MANUFACTURER Plasma Biologicals Services, Inc., Ashville, North Carolina. RECALLED BY Manufacturer, by letter dated May 6, 1999. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor who had been incarcerated. ________ PRODUCT Source Leukocytes. Recall #B-1085-0. CODE Unit #3600010. MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas. RECALLED BY Manufacturer, by fax on May 5, 1999, and August 22 and 30, 1999. Firm- initiated recall ongoing. DISTRIBUTION Pennsylvania. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had previously been deferred for high risk behavior. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1140/1141-0. CODE Unit #0972298. MANUFACTURER Community Blood Bank of Erie County, Erie, Pennsylvania. RECALLED BY Manufacturer, by telephone on June 26, 2000, and by fax on June 21, 2000. Firm-initiated recall complete. DISTRIBUTION Pennsylvania and New Jersey. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who was previously deferred for receiving a tattoo within the past 12 months. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1155/1156-0. CODE Unit Numbers: 13GQ24219 and 13GM31649. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by letter dated October 30, 1999, or November 3, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 2 units of each component were distributed. REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1157/1158-0. CODE Unit #13GC68251. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by letter dated November 5, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1159/1160-0. CODE Unit Numbers: 13FN43186 and 13FN40838. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by letter dated November 2, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 2 units of each component were distributed. REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1161/1162-0. CODE Unit #13L93682. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by letter dated November 24, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor traveled to an area considered endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1163/1164-0. CODE Unit #13GX17710. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by letter dated November 16, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-1189-0. CODE Unit #3213206. MANUFACTURER Florida Blood Services, St. Petersburg, Florida. RECALLED BY Manufacturer, by telephone and letter on May 1, 1997. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from an unsuitable donor. ________ PRODUCT Red Blood Cells. Recall #B-1191-0. CODE Unit #30-09381. MANUFACTURER Saginaw Valley Blood Program, Saginaw, Michigan. RECALLED BY Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, Michigan, by letter on September 21, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. 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 Red Blood Cells. Recall #B-1192-0. CODE Unit #03GN23244. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by letters dated February 2 and 17, 1999. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 1 unit ws distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-1193/1195-0. CODE Unit #12X81916. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letters on May 12 and 31, 2000, and by telephone on May 15, 2000. Firm-initiated recall complete. DISTRIBUTION North Carolina and South Carolina. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor having been diagnosed with Sarcoidosis. ________ PRODUCT Red Blood Cells. Recall #B-1196-0. CODE Unit Numbers: 21GE15613 and 21GE13842 . MANUFACTURER American Red Cross, Portland, Oregon. RECALLED BY Manufacturer, by letters dated February 29, 2000, and April 7, 2000. Firm-initiated recall complete. DISTRIBUTIONB Pennsylvania and Washington state. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Source Plasma. Recall #B-1203-0. CODE G-11177-036, G-18743-036, G-19332-036, G-51405-036, G-52260-036, G-52708-036, G-53074-036, G-54494-036, G-39009-036, G-39151-036, G-90258-036, G-83456-036, G-87193-036, G-91993-036, G-71947-036, G-72220-036, G-34542-036, G-56940-036, G-73406-036, G-73835-036, G-36957-036, G-37433-036, G-92024-036, G-92720-036, G-93073-036, G-18833-036, G-93518-036. MANUFACTURER Alpha Therapeutic Corporation, Los Angeles, California. RECALLED BY Manufacturer, by letters dated December 9, 1998, February 4, 1999, or August 31, 2000. Firm-initiated recall complete. DISTRIBUTION Florida, New Jersey, Germany, Spain, Austria, Italy. QUANTITY 27 units were distributed. REASON Blood products tested negative for HBsAg, but were collected from a donor who previously tested repeatedly reactive for HBsAg. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1211/1212-0. CODE Unit #29KN20553. MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by letters dated April 4, 2000 and May 4, 2000. Firm- initiated recall complete. DISTRIBUTION North Carolina and Puerto Rico. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with Porphyria Cutanea Tarda. ________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-1214/1215-0. CODE Unit #3364313. MANUFACTURER Florida Blood Services, St. Petersburg, Florida. RECALLED BYB Manufacturer, by telephone on July 9, 1998. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit of each component was distributed. REASON Blood products were incorrectly tested for anti-HCV. ________ PRODUCT Platelets, Pheresis. Recall #B-1218-0. CODE Unit #2505602. MANUFACTURER Central Texas Regional Blood and Tissue Center, Austin, Texas. RECALLED BY Manufacturer, by letter dated August 17, 1999. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product tested negative for Cytomegalovirus (CMV), but was collected from a donor who previously tested CMV positive. ________ PRODUCT Red Blood Cells. Recall #B-1220-0. CODE Unit Numbers: 36GW00642, 36GW00648, 36GW00650, 36GW00652, and 36GW00656 MANUFACTURER The American National Red Cross, Columbia, South Carolina. RECALLED BY Manufacturer, by letter dated May 11, 1999. Firm-initiated recall complete. DISTRIBUTION South Carolina. QUANTITY 5 units were distributed. REASON Blood products, tested positive for Cytomegalovirus (CMV), but were labeled as negative for CMV. ________ PRODUCT Red Blood Cells. Recall #B-1221-0. CODE Unit #21KK18380. MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter dated May 12, 2000. Firm-initiated recall complete. DISTRIBUTION California. 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-1222-0. CODE Unit #2257373. MANUFACTURER Central Florida Blood Bank, Inc., Orlando, Florida. RECALLED BY Manufacturer, by telephone on October 28, 1999. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product was positive for anti-Rho(D) antibodies, was labeled negative for unexpected antibodies and distributed for transfusion. ________ PRODUCT Platelets. Recall #B-1225-0. CODE Unit Numbers: 3185171, 3185170, 3185417, 3183986, 3348267, 3348269, 3348271, 3183998, 3801648, 3185250, 3185439, 3185440, 3185257, 3185435, 3801649, 3185444, 3800870, 3800865, 3348287, 3800875, 3185437, 3800869, 3185436. MANUFACTURER Florida Blood Services, St. Petersburg, Florida. RECALLED BY Manufacturer, by telephone on January 14, 1998, followed by letter. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 23 units were distributed. REASON Blood products were manufactured using a centrifuge that failed quality control testing. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Source Leukocytes; d) Fresh Frozen Plasma; e) Recovered Plasma. Recall #B-1226/1230-0. CODE Unit Numbers: a) 7812957, 7940442, 7913582, 7875499; b) 7913582, 7875499; c) 7812957; d) 7940442, 7913582; e) 7812957, 7913582. MANUFACTURER South Florida Blood Banks, Inc., West Palm Beach, Florida. RECALLED BY Manufacturer, by letter on December 13, 1999. Firm initiated recall complete. DISTRIBUTION Florida and California. QUANTITY a) 4 units; b) 2 units; c) 1 unit; d) 2 units; e) 2 units were distributed. REASON Blood products were collected from a donor with a history of jaundice. ________ PRODUCT a) Red Blood Cells, Leukoreduced, Irradiated; b) Cryoprecipitated AHF. Recall #B-1231/1232-0. CODE Unit #12GS17921. MANUFACTURER American Red Cross Blood Services, Durham, North Carolina. RECALLED BY American Red Cross Blood Services, Charlotte, North Carolina, by letter dated March 2, 2000. Firm-initiated recall complete. DISTRIBUTION North Carolina and Georgia. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of having tested positive for Hepatitis A. ________ PRODUCT Red Blood Cells. Recall #B-1233-0. CODE Unit #3838725. MANUFACTURER Central Florida Blood Bank, Inc., Orlando, Florida. RECALLED BY Manufacturer, by telephone on July 1, 1999. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product was identified by the donor for confidential unit exclusion was distributed. ________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Platelets; d) Fresh Frozen Plasma; e) Recovered Plasma. Recall #B-1234/1238-0. CODE Unit Numbers: a) 03FC40408, 03FC48774; b) 03LM60825; c) 03LM60825; d) 03FC40408; e) 03FC48774, 03LM60825. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by letter dated April 14 and 21, 1999. Firm-initiated recall complete. DISTRIBUTION Georgia and California. QUANTITY a) 2 units; b) 1 unit; c) 1 unit; d) 1 unit; e) 2 units were distributed. REASON Blood products were collected from a donor with a history of jaundice. ________ PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Cryoprecipitated AHF; c) Recovered Plasma. Recall #B-1239/1241-0. CODE Unit #21Y60267. MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter dated March 10, 2000, and by telephone on March 3, 2000. Firm-initiated recall complete. DISTRIBUTION Washington State and Oregon. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of jaundice. ________ PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c) Recovered Plasma. Recall #B-1242/1244-0. CODE Unit Numbers: 21KG29045, 21KE06409. MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letters dated March 23, 2000 or April 4, 2000, and April 28, 2000, and by telephone on March 13, 2000. Firm-initiated recall complete. DISTRIBUTION Oregon, California, Switzerland. QUANTITY 2 units of each component were distributed. REASON Blood products were collected from a donor with a history of having tested positive for Hepatitis C. ________ PRODUCT a) Red Blood Cells; b) Platelets, Pooled; c) Fresh Frozen Plasma. Recall #B-1245/1247-0. CODE Unit Numbers: a) W111758; b) W11758 (Pool #AP13972); c) W111758 (Pool #HP04190). MANUFACTURER Puget Sound Blood Center and Program, Seattle, Washington. RECALLED BY Manufacturer, by letter dated April 27, 2000. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had been exposed to Hepatitis A within one year of donation. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma. Recall #B-1248/1251-0. CODE Unit Numbers: a) 12GN55638, 12Z24968, 12F00460, 12V11106; b) 12V11106; c) 12GN55638; d) 12Z24968, 12F00460, 12V11106. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated April 18, 2000, and by telephone on April 14, 2000. Firm-initiated recall complete. DISTRIBUTION North Carolina, South Carolina, Puerto Rico, California. QUANTITY a) 4 units; b) 1 unit; c) 1 unit; d) 3 units were distributed. REASON Blood products were collected from a donor with a history of having tested positive for hepatitis B. ________ PRODUCT Source Plasma. Recall #B-1252-0. CODE Unit Numbers: T-48341-036, T-48251-036, T-48185-036, T-47969 036, T-47866-036, T-47816-036, T-47738-036, T-47710-036, T-47314-036, T-47191-036, T-47104-036, T-47051-036, T-46988-036, T-46926-036, T-46871-036, T-46811-036, T-46752-036, T-46725-036, T-46682-036, T-46643-036, T-46578-036, T-46554-036, T-46499-036, T-46491-036, T-46462-036, T-46454-036, T-46427-036, T-46410-036, T-46372-036, T-46354-036, T-46325-036, T-46306-036, T-46235-036, T-46215-036, T-46160-036, T-46142-036, T-46085-036, T-46070-036, T-46018-036, T-46000-036, T-45933-036, T-45862-036 . MANUFACTURER Alpha Therapeutic Corporation, Los Angeles, California. RECALLED BY Manufacturer, by letter dated March 13, 2000. Firm-initiated recall complete. DISTRIBUTION Spain. QUANTITY 42 units were distributed. REASON Blood products were collected form a donor who was incarcerated and received a tattoo within 12 months of donation. ________ PRODUCT Platelets. Recall #B-1253-0. CODE Unit Numbers: 8051249 and 8051250. MANUFACTURER South Florida Blood Banks, West Palm Beach, Florida. RECALLED BY Manufacturer, by letter dated December 16, 1999. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 2 units were distributed. REASON Blood products were collected from donors who were previously deferred for a history of incarceration. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1254/1255-0. CODE Unit #03GN25397. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by letter dated June 4, 1999. Firm-initiated recall complete. DISTRIBUTION Georgia and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported multiple high risk behaviors. ________ PRODUCT Red Blood Cells. Recall #B-1257-0. CODE Unit Numbers: 3493449 and 3486282. MANUFACTURER Florida Blood Services, St. Petersburg, Florida. RECALLED BY Manufacturer, by fax on January 22, 1998. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 2 units were distributed. REASON Blood products corresponded to a unit of pooled platelets that was implicated in a transfusion reaction. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma for Non-Injectable Use; e) Recovered Plasma. Recall #B-1262/1266- 0. CODE Unit Numbers: a) 12FP33160, 12FT71151, 12FP10403, 12FP04489, 12FH57737; b) 12FH57737; c) 12FH57737; d) 12FT71151, 12FP10403; e) 12FP33160, 12FH57737. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated May 3, 1999. Firm-initiated recall complete. DISTRIBUTION Massachusetts, North Carolina, Switzerland. QUANTITY a) 5 units; b) 1 unit; c) 1 unit; d) 2 units; e) 2 units were distributed. REASON Blood products were collected from a donor with a history of having tested positive for hepatitis.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Red Blood Cells. Recall #B-674-0. CODE Unit Numbers: 17FZ26372 and 17FZ26376. MANUFCTURER American Red Cross Blood Services, St. Paul, Minnesota. RECALLED BY Manufacturer, by telephone on December 20, 1999. Firm-initiated recall complete. DISTRIBUTION Minnesota. QUANTITY 2 units were distributed. REASON Blood product was labeled with an extended expiration date. ________ PRODUCT Fresh Frozen Plasma. Recall #B-688-0. CODE Unit #7618991. MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana. RECALLED BY Manufacturer, by telephone on November 11, 1999. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit was distributed. REASON Unlicensed blood product was distributed in interstate commerce. ________ PRODUCT a) Black Willow Allergenic, Patient Treatment Vials; b) Black Willow Allergenic, Scratch Test Vials. Recall #B-1177/1178-0. CODE Lot Numbers: a) A0010704; b) B0010703 and B0011041. MANUFACTURER Allergy Laboratories of Ohio, Inc., Columbus, Ohio. RECALLED BY Manufacturer, by telephone on July 21, 2000, and by letter dated July 25, 2000. Firm-initiated recall complete. DISTRIBUTION New York and Missouri. QUANTITY a) 1 vial; b) 3 vials were distributed. REASON Allergenic extracts were labeled with the incorrect concentrations. ________ PRODUCT Red Blood Cells. Recall #B-1190-0. CODE Unit Numbers: 3491048. 3491053, 3491054, 3491056. MANUFACTURER Florida Blood Services, Tampa, Florida. RECALLED BY Florida Blood Services, St. Petersburg, Florida, by fax on December 9, 1997. Firm-initiated recall complete. DISTRIBUTION New Jersey. QUANTITY 4 units were distributed. REASON Blood products were labeled with an extended expiration date. ________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocyte Reduced; c) Platelets; d) Fresh Frozen Plasma. Recall #B-1197/1200-0. CODE Unit Numbers: a) 12FS77058, 12FT67413, 12FP05971 b) 12FS81558, 12FS80498, 12FS77970; c) 12FS80498; d) 12FS79487. COLLECTION SITE American Red Cross Blood Services, Durham, North Carolina. RECALLED BY American Red Cross Blood Services, Charlotte, North Carolina, by letters dated May 10, 1999 and June 9, 1999. Firm-initiated recall complete. DISTRIBUTION North Carolina and Connecticut. QUANTITY a) 3 units; b) 3 units; c) 1 unit; d) 1 unit distributed. REASON Blood products were collected from a donor with a history of Idiopathic Thrombocytopenic Purpura. ________ PRODUCT Platelets. Recall #B-1210-0. CODE 3613166, 3618961, 3618960, 3618962, 3618965, 3618966, 3689249, 3689253, 3689254, 3689258, 3689263, 3689266, 3890260, and Platelets, Pheresis, units 3613164 and 3618964. MANUFACTURE Gulf Coast Regional Blood Center, Houston, Texas. RECALLED BY Manufacturer, by telephone or fax on August 2, 1999. Firm-initiated recall complete. DISTRIBUTION Texas and New York. QUANTITY 13 units of platelets and 2 units of Platelets, Pheresis were distributed. REASON Blood products were stored at unacceptable temperatures or manufactured from units of whole blood that were collected at unacceptable temperatures. ________ PRODUCT Recovered Plasma. Recall #B-1213-0. CODE Unit #29KN20553. MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by fax on April 6, 2000. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with Porphyria Cutanea Tarda. ________ PRODUCT Red Blood Cells. Recall #B-1216-0. CODE Unit Numbers: 12GM57364 and 12LK28263. COLLECTION SITE American Red Cross Blood Services, Asheville, North Carolina. RECALLED BY American Red Cross Blood Services, Charlotte, North Carolina, by letter dated April 11, 2000. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor with a history of Idiopathic Thrombocytopenic Purpura. ________ PRODUCT Platelets Pheresis, Leukocytes Reduced. Recall #B-1219-0. CODE Unit Numbers 12710 and 12750. MANUFACTURER Carolina-Georgia Blood Center, Inc., Greenville, South Carolina. RECALLED BY Manufacturer, by letter dated October 29, 1998. Firm-initiated recall complete. DISTRIBUTION South Carolina. QUANTITY 2 units were distributed. REASON Blood products were collected from an unsuitable donor due to use of the medication Propecia. ________ PRODUCT Red Blood Cells. Recall #B-1256-0. CODE 3342073, 3473041, 3218048, 3465987, 3472594. MANUFACTURER Florida Blood Services, St. Petersburg, Florida. RECALLED BY Manufacturer, by fax on October 6, 1997. Firm-initiated recall complete. DISTRIBUTION Florida, New Jersey, New York. QUANTITY 5 units were distributed. REASON Blood products corresponded to a unit of pooled Platelets that was positive for Propionibacterium acnes. ________ PRODUCT Recovered Plasma. Recall #B-1258-0. CODE Unit #3813090. MANUFACTURER Florida Blood Services, St. Petersburg, Florida. RECALLED BY Manufacturer, by fax on March 16, 1998. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product corresponded to a unit of platelets that was positive for Staphylococcus waraneri and Propionibacterium acnes, and was implicated in a transfusion reaction. ________ PRODUCT Cryoprecipitated AHF. Recall #B-1261-0. CODE Unit #K14648. MANUFACTURER Carolina-Georgia Blood Center, Greenville, South Carolina. RECALLED BY Manufacturer, by telephone on December 17, 1998. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 unit was distributed. REASON Blood product was prepared from plasma that was not separated from the red blood cells within eight hours of collection.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Centrex Bipolar Endoprothesis Comp, used in comjunction with a femoral stem component in the reconstruction of a femoral head damaged by fresh fracture non-union aseptic necrosis of the femoral head and neck or by osteoarthritis or post-traumatic arthritis. Recall #Z-963-0. CODE Catalog No. 6225-2-846, Lot Code GOUDA. MANUFACTURER Howmedica Osteonics Corporation, Rutherford, New Jersey. RECALLED BY Manufacturer, by letter dated June 22, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Australia and Canada. QUANTITY 11 units were distributed. REASON A 26mm UHWPE insert was issued instead of a 28mm insert. ________ PRODUCT Titanium Roof Pile Screw, Catalog #1001-05-501, intended for use to fixate Depuy Protrusio Rings. Recall #Z-1022-0. CODE Lot TE7GR1. MANUFACTURER DePuy Orthopaedics, Inc., Warsaw, Indiana. RECALLED BY Manufacturer, by letter on or about April 12, 2000 and on May 17, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide and Canada. QUANTITY 20 pieces were distributed. REASON The device was incorrectly labeled as sterile when it was not properly sterilized. ________ PRODUCT Power Chairs: a) Rascal Model Numbers RAS 545 and RAS 445; b) Chauffeur Model Numbers: P48, S45, X48, and X48E. Recall #Z-1029/1030-0. CODE Identified power chairs are: PC004492, PC004493, PC004494, PC004501, PC004502, PC004508, PC004511, PC004527, PC004532, PC004534, PC004536, PC004552, PC004553, PC004555, PC004556, PC004579, JS004709. MANUFACTURER Electric Mobility Corporation, Sewell, New Jersey. RECALLED BY Manufacturer, by letter August 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION a) North Carolina, Indiana, Florida, Pennsylvania, New York, Kentucky, California, Kansas, Mississippi, and West Virginia, England; b) Alabama. QUANTITY 17 chairs were distributed. REASON The Power chairs' controller program does not meet the original engineering specifications. ________ PRODUCT Isoniazid drug lot No. 9335260 used in the following kits: BACTEC(tm) S.I.R.E. Drug Kit used for susceptibility testing of Mycobacterium tuberculosis, Catalog No. 442102, Lot Nos. 9327296, 93442298, 9327298; BACTEC(tm) Isoniazid Drug Kit used for isoniazid susceptibility testing, Catalog No. 442146, Lot No. 9327297. Recall #Z-1032-0. CODE See above. MANUFACTURER Becton Dickinson Microbiology Systems, Cockeysville, Maryland. RECALLED BY Becton Dickinson Microbiology Systems, Sparks, Maryland, by letter on August 22 and 25, 2000, followed by telephone on September 6, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Hong Kong, Philippines, Australia, Brazil, New Delhi, Singapore, Puerto Rico, Belgium, Canada, Argentina. QUANTITY 148 Isoniazid Drug Kits and 490 S.I.R.E. Kits were distributed. REASON Some bottles of the products listed above are labeled Isoniazid but actually contain Streptomycin.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT Vitros Immunodiagnostic Products brand of: Prolactin Reagent Pack, 100 test units per pack Catalog No.184 9793; and associated Vitros Prolactin Calibrators, Catalog No. 111 3596, for in vitro diagnostic use only. Recall #Z-1023/1024-0. CODE Catalog No. 1849793, Lot No.90, EXP 09/15/2000; Catalog No. 1112595, Lot No.90, EXP 09/15/2000. MANUFACTURER Ortho-Clinical Diagnostics, Inc., Forest Farm Estate Whitchurch, Cardiff, UK. RECALLED BY Ortho-Clinical Diagnostics, Inc., Rochester, New York, by letter dated May 24, 2000. Firm-initiated recall ongoing. DISTRIBUTION Alabama, Arizona, Kansas, Missouri, Virginia, Washington state, Argentina, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Puerto Rico, Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain. QUANTITY 764 packs were distributed. REASON Calibration failures may occur when using this lot of product due to lower than expected light unit output for the level 1 calibrator. _______ PRODUCT Replace 4.3mm Conical Abutment, 4.3mm diameter x 4.5 mm height, Catalog #43503. An abutment is used either for single or multiple unit, screw- retained prosthetic restorations. Recall #Z-1025-0. CODE Lot #308039 EXP 2/05. MANUFACTURER Nobel Biocare USA, Inc., Yorba Linda, California. RECALLED BY Manufacturer, by letter on June 13, 2000, followed by telephone. Firm- initiated recall ongoing. DISTRIBUTION Florida, Illinois, Louisiana, Michigan, Minnesota, North Carolina, New York, Ohio, Pennsylvania, Texas, Hong Kong, Israel, Mexico. QUANTITY 40 units were distributed. REASON The conical abutment was not the size as labeled. ________ PRODUCT IMC (Intramobile Connector) Conversion Screw, 3.3mm diameter, Catalog #8198CA. An IMC cylinder is used for either single or multiple unit, screw-retained prosthetic restorations. Recall #Z-1026-0. CODE Lot #310052. MANUFACTURER Nobel Biocare USA, Inc., Yorba Linda, California. RECALLED BY Manufacturer, by letter on June 14, 2000. Firm-initiated recall ongoing. DISTRIBUTION Arizona, Connecticut, Delaware, Florida, Indiana, Massachusetts, Maryland, Michigan, New Jersey, New York, Ohio, Texas. QUANTITY 29 units were distributed. REASON The screw in the package is incorrect. ________ PRODUCT Gold Cylinder Fastening Screw, 3.3mm diameter x 12 mm height. Catalog #8905A. an IMC cylinder is used either for single or multiple unit, screw-retained prosthetic restorations. Recall #Z-1027-0. CODE Lot #309634. MANUFACTURER Nobel Biocare USA, Inc., Yorba Linda, California. RECALLED BY Manufacturer, on June 8, 2000. Firm-initiated recall complete. DISTRIBUTION New Jersey. QUANTITY 6 units were distributed. All units have been returned. REASON The screw in the package is incorrect. ________ PRODUCT Replace 4.3mm Conical Abutment, 4.3mm diameter x 1.5mm height, Catalog #43500. An abutment is used either for single or multiple unit, screw- retained prosthetic restorations. Recall Z-1028-0. CODE Lot #308028 EXP 2/05. MANUFACTURER Nobel Biocare USA, Inc., Yorba Linda, California. RECALLED BY Manufacturer, by letter on June 12, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, Florida, Idaho, Indiana, New York, Colombia, Hong Kong, Mexico, South Korea. QUANTITY 41 units were distributed. REASON The conical abutment was not the size as labeled. ________ PRODUCT ProCide-D Plus Sterilizing & Disinfecting Solution. Recall #Z-1031-0. CODE Lot #200020002 EXP 7/02 MANUFACTURER Metrex Research Corporation, Parker, Colorado. RECALLED BY Sybron Dental Specialties, Inc., Orange, California, letter on August 7, 2000. Firm-initiated recall ongoing. DISTRIBUTION Alabama, Iowa, Indiana, New York, Oregon, Pennsylvania, West Virginia, Texas. QUANTITY 280 gallons were distributed. REASON Part of the subject lot was mislabeled as Procide-D Plus, which contains 3.4% glutaraldehyde, rather Procide-D, which contains 2.5% glutaraldehyde. END OF ENFORCEMENT REPORT FOR OCTOBER 4,2000. ####
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