May 28, 1997 97-22 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ============ _______________ PRODUCT Cap'n Crunch Bars, Crunchy Marshmallow Treats, 8-0.78 ounces individually wrapped bars per retail box, net weight 6.2 ounces, 12 boxes per case. Recall #F-411-7. CODE 7CF20Bxx on bars and retail box, FEB 20 97 CF on case. MANUFACTURER Campfire Foods, Clearfield, Utah. RECALLED BY Quaker Oats Company, Chicago. Illinois., by memorandum dated April 14, 1997, followed by letter dated April 15, 1997. Firm-initiated recall ongoing. DISTRIBUTION Wisconsin, Ohio, Iowa, Illinois. QUANTITY 4,811 cases were distributed; firm estimated that 50 percent of the product remained on market at time of recall initiation. REASON Product fails to declare whey on the ingredient panel of the retail cartons. _______________ UPDATE Frozen Strawberry Fruit Bars, Recall #F-409-7, which appeared in the May 21, 1997 Enforcement Report erroneously reported code "11-04-96". This code is not under recall. Only bars with an October 1996 code are under recall. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III =========== _______________ PRODUCT (a) Ethex brand Guaifenex LA, Guaifenesin Extended-release Tablets, Expectorant, 600-mg tablets packaged in 100-tablet bottles, RX, indicated for the temporary relief of coughs associated with respiratory tract infections and related conditions (b) Ethex brand Guaifenex-Rx Tablets, Guaifenesin/Pseudoephedrine HCl Extended-release Tablets 14 Day Treatment Regimen, each 14-day treatment regimen consists of 56 tablets packaged in blister packs containing 600-mg guaifenesin and 60-mg pseudoephedrine HCl tablets to be used for the A.M. dosage and 600-mg. guaifenesin tablets for the P.M. dosage, Rx, indicated for the temporary relief of nasal congestion associated with respiratory tract infections and related conditions. Recall #D-175/176-7. CODE (a) Lot #L8541, EXP 8/98 (b) - Lot #L8877, EXP 8/98. MANUFACTURER: KV Pharmaceutical Company, Maryland Heights, Missouri. RECALLED BY Ethex Corporation, St. Louis, Missouri, by letter sent on April 21, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY (a) 3,418 bottles were distributed; (b) 21,494 cartons (56 tablets per carton) were distributed. REASON Product failed dissolution specifications. _______________ PRODUCT Sedapap Tablets, (50 mg butalbital/650 mg, Acetaminophen) packaged in bottles of 100, Rx, indicated for the relief of tension headaches. Recall #D-177-7. CODE Lot numbers: S609 and S610. MANUFACTURER Graham Laboratories, Hobart, New York. RECALLED BY Merz Pharmaceuticals, Greensboro, North Carolina, by letter on April 23, 1997. Firm-initiated recall ongoing. DISTRIBUTION North Carolina, South Carolina, Georgia, Florida, Alabama, Mississippi, Virginia, West Virginia, Tennessee. QUANTITY 4,636 bottles of lot S609 and 4,829 bottles of lot S610 were distributed; firm estimated that 3,363 bottles remained on market at time of recall initiation. REASON Discoloration. _______________ PRODUCT Ibuprofen Tablets, USP, 400 mg, in 500 count, for use as an anti-inflammatory, distributed by Par Pharmaceutical. Recall #D-178-7. CODE Lot #13574 EXP 8/97. MANUFACTURER Knoll Pharmaceutical Company, Mount Olive, New Jersey. RECALLED BY Manufacturer, by telephone on February 24, 1997, followed by letter on February 26, 1997 and March 6, 1997. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY Approximately 4,718 bottles were distributed; firm estimates none remains on the market. REASON Dissolution specification failure. _______________ PRODUCT Tussex-DM Expectorant Cough Suppressant, alcohol free, (100 mg guaifenesin/15 mg dextromethorphan), in 2 fluid ounce bottles. Recall #D-179-7. CODE Lot numbers: 555-215, 55-334, 56-201. MANUFACTURER Ferndale Laboratories, Inc., Ferndale, Michigan. RECALLED BY Manufacturer, by letter issued on April 22, 1997. Firm-initiated recall ongoing. DISTRIBUTION Alabama, Arizona, California, Colorado, Connecticut, Delaware, Illinois, Indiana, Louisiana, Michigan, Missouri, New York, North Carolina, Ohio, Tennessee, Texas, Virginia, West Virginia, Wisconsin QUANTITY 38,428 bottles were distributed. REASON Ingredient non-uniformity. _______________ PRODUCT Aquaphilic TAC 1/4 (Triamcinolone Acetonide 0.025%) Ointment, in 1 pound jars, Rx for dermatology indications. Recall #D-180-7. CODE Lot #4382/025 EXP 2/28/97. MANUFACTURER Medco Lab, Inc., Sioux City, Iowa. RECALLED BY Manufacturer, by letter sent on or about November 15, 1996. Firm-initiated recall complete. DISTRIBUTION Iowa. QUANTITY 139 jars were distributed. REASON Subpotency. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======== _______________ PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-672/673-7. Code Unit numbers: 9513701, 9132464. MANUFACTURER Oklahoma Blood Institute, Oklahoma City, Oklahoma. RECALLED BY Manufacturer, by fax on July 11, 1995 or August 1, 1995. Firm-initiated recall ongoing. DISTRIBUTION Texas, Oklahoma, Pennsylvania. QUANTITY 2 units of each component were distributed. REASON Blood products were collected from a donor who emigrated from an area considered endemic for malaria. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma. Recall #B-703/705-7. CODE Unit numbers: (a) 8401721, 8441420; (b) 8401721; (c) 8401721. MANUFACTURER Community Blood Centers of South Florida, Inc., Lauderhill, Florida. RECALLED BY Manufacturer, by fax or telephone on July 7, 1995. Firm-initiated recall complete. DISTRIBUTION Florida and New York. QUANTITY (a) 2 units; (b) 1 unit; (c) 1 unit was distributed. REASON Blood products were collected from a donor with a history of receiving human pituitary-derived growth hormone. _______________ PRODUCT Red Blood Cells. Recall #B-706-7. CODE Unit #8553034. MANUFACTURER Community Blood Centers of South Florida, Inc., Lauderhill, Florida. RECALLED BY Manufacturer, by fax or telephone on January 4, 1996. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 unit was distributed. REASON Blood product tested initially reactive for the Hepatitis B Surface Antigen (HbsAg), but retested non-reactive at a different processing laboratory using a different test methodology. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Frozen Plasma-Cryoprecipitate Removed; (d) Cryoprecipitate. Recall #B-707/710-7. CODE Unit #8645910. MANUFACTURER Community Blood Centers of South Florida, Inc., Lauderhill, Florida. RECALLED BY Manufacturer, by fax or telephone on February 11, 1997. Firm-initiated recall complete. DISTRIBUTION Florida, New York, North Carolina. -4-QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported a history of high risk behavior. _______________ PRODUCT Red Blood Cells. Recall #B-715-7. CODE Unit #29271-9739, 29271-9740. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by telephone on December 17, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 2 units were distributed. REASON Blood products were labeled as "Nonreactive for CMV Antibody" but were not tested for CMV. _______________ PRODUCT Red Blood Cells. Recall #B-716-7. CODE Unit #29272-0662. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by telephone and by letter dated February 20,1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to a malarial endemic area. _______________ PRODUCT Red Blood Cells. Recall #B-721-7. CODE Unit #12LJ20509. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by telephone and letter on February 7, 1997. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. _______________ PRODUCT Red Blood Cells. Recall #B-722-7. CODE Unit #12E89701. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated February 28, 1997. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled in an area considered endemic for malaria. _______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-725/726-7. CODE Unit #7501394. MANUFACTURER Manatee Community Blood Center, Bradenton, Florida. RECALLED BY Manufacturer, by letter dated April 6, 1995. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor taking the drug Proscar. _______________ PRODUCT Fresh Frozen Plasma. Recall #B-727-7. CODE Unit #1382123. MANUFACTURER LifSource, Glenview, Illinois. RECALLED BY Manufacturer, by letter dated March 11, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of cancer. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-728/729-7. CODE Unit #28028-0015. MANUFACTURER United Blood Services, San Angelo, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated May 30, 1996. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit of each component was distributed. REASON Blood products tested negative for the antibody to the human T-lymphotropic virus type I (anti-HTLV-1), but were collected from a donor who previously tested repeatedly reactive for anti-HTLV-1 on two occasions. _______________ PRODUCT Red Blood Cells. Recall #B-730-7. CODE Unit #13FY16091. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by telephone on January 27, 1997. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who subsequently requested that his blood not be used was distributed after receipt of the post donation information. _______________ PRODUCT Whole Blood, CPD. Recall #B-734-7. CODE Unit #29443-7931. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by telephone on March 14, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was held at room temperature for an unknown period of time and released for distribution. _______________ PRODUCT Cytogam-(CVM-IGIV), Cytomegalovirus Immune Globulin Intravenous (Human). Recall #B-736-7. CODE Unit #MV1CMV-38 Exp 8/15/97. MANUFACTURER Massachusetts Public Health Biologic Laboratories, Jamaica Plains, Massachusetts. RECALLED BY Manufacturer, by letter dated May 6, 1997. Firm-initiated recall ongoing. DISTRIBUTION Delaware and Maryland. QUANTITY 3,677 vials were distributed. REASON Immune Globulin product was found in post-release testing to have elevated levels of the plasma Pre-Kallikrein Activator (PKA). _______________ PRODUCT Platelets, Pheresis. Recall #B-739-7. CODE Unit numbers: 53LT50666, 53LT50321, 53LT50042, 53LT49459, 53LT48864. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated January 9, 1997. Firm-initiated recall complete. DISTRIBUTION Maryland and District of Columbia. QUANTITY 5 units were distributed. REASON Blood products were collected from a donor who reported travel to an area considered endemic for malaria. _______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-742/743-7. CODE Unit numbers: 55KH05716, 55L90976, 55H28304, 55H30829, 55L97114, 55W04648, 55H37746, 55W07783. MANUFACTURER American Red Cross Blood Services, Little Rock, Arkansas. RECALLED BY Manufacturer, by letter dated August 27, 1996. Firm-initiated recall complete. DISTRIBUTION Arkansas, California, Switzerland. QUANTITY 8 units were distributed. REASON Blood products were collected from a donor with a history of cancer. _______________ PRODUCT Red Blood Cells. Recall #B-745-7. CODE Unit numbers: 1607205, 1607206, 1607207. MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana. RECALLED BY Manufacturer, by telephone on November 8, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana. Quantity 3 units were distributed. REASON Blood products had an extended expiration date. _______________ PRODUCT (a) Platelets; (b) Recovered Plasma, Frozen. Recall #B-747/748-7. CODE Unit #13Q93764. MANUFACTURER American Red Cross, Detroit, Michigan. RECALLED BY Manufacturer, by letter dated January 7, 1997. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit of each component was distributed. REASON Blood products corresponded to Red Blood Cells which were returned because of confirmed hemolyzed segments. _______________ PRODUCT Red Blood Cells. Recall #B-749-7. CODE Unit #13FJ18182. MANUFACTURER American Red Cross, Detroit, Michigan. RECALLED BY Manufacturer, by telephone on January 12, 1997. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who received a tattoo within twelve months of donation. _______________ PRODUCT Platelets. Recall #B-751-7. CODE Unit numbers: 13FS42641, 13FS42647. MANUFACTURER American Red Cross, Detroit, Michigan. RECALLED BY Manufacturer, by telephone on November 13, 1996, and by letter dated December 12, 1996. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 2 units were distributed. REASON Blood products which corresponded to Red Blood Cells were returned because of confirmed clotted segments. _______________ PRODUCT (a) Plasma - Cryoprecipitate Reduced; (b) Recovered Plasma. Recall #B-752/753-7. CODE Unit #55R91924. MANUFACTURER American Red Cross, Little Rock, Arkansas. RECALLED BY Manufacturer, by letter dated March 25, 1997. Firm-initiated recall complete. DISTRIBUTION Arkansas. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor who received ear piercing within twelve months of donation. _______________ PRODUCT Source Plasma. Recall #B-754-7. CODE Unit numbers: T92158, T93290, T95320, T96418, T96744, T97379, T97797, T98483, T99565, T9V169, T9W132, T9Z477, VR2554, VR5660, VR5809, VRW277, VRX023, VRY455, VRZ367, VSH681, VSI111, VSJ463, VSK641. MANUFACTURER Centeon Bio Services, Inc., Fort Worth, Texas. RECALLED BY Manufacturer, by letter dated July 10, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 23 units were distributed. REASON Blood products were collected from a donor with a history of IV drug use. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma; (d) Recovered Plasma. Recall #B-755/757-7. CODE Unit numbers: 17030-3908, 17030-7406, 17032-1780, 17032-6076, 17034-6362, 17175-7608, 17176-2627, 17178-2371, 17034-6362, 17175-7608, 17176-2627, 17178-2371, 17178-7260, 28029-2509, 28105-6870, 28105-7910, 28105-9152, 28106-1523, 28106-2227, 17178-2371, 17178-7260; (b) 17302-6076, 17175-7608, 28029-2509, 28105-7910, 28105-9152; (c) 17030-3908, 17030-7406, 17032-6076, 17034-6362, 17175-7608, 17176-2627, 28105-6870, 28106-1523. MANUFACTURERS United Blood Services, San Angelo, Texas; United Blood Services, McAllen, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letters dated May 30 or 31, 1996. Firm-initiated recall ongoing. DISTRIBUTION Texas, Florida, Switzerland. QUANTITY (a) 21 units; (b) 5 units; (8 units were distributed. REASON Blood products tested negative for the antibody to the human T-lymphotropic virus type 1 (anti-HTLV-I), but were collected from donors who previously tested repeatedly reactive for anti-HTLV-1 on two occasions. _______________ PRODUCT Red Blood Cells. Recall #B-759-7. CODE Unit #18N57687. MANUFACTURER American Red Cross Blood Services, Lansing, Michigan. RECALLED BY Manufacturer, by letter dated January 6, 1997. 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 considered endemic for malaria. _______________ PRODUCT Plasma, Pheresis. Recall #B-760-7. CODE Unit #3077567. MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas. RECALLED BY Manufacturer, by fax on January 15, 1997. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product corresponded to a unit of Platlets, Pheresis, that was positive for Staphylococcus aureus. _______________ PRODUCT Platelets. Recall #B-761-7. CODE Unit #T75691. MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois. RECALLED BY Manufacturer, by telephone on March 17, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product tested negative for the antibody to the hepatitis C virus encoded antigen (anti-HCV), but was collected from a donor who previously tested repeatedly reactive for anti-HCV. _______________ PRODUCT Recovered Plasma. Recall #B-762-7. CODE Unit #21Q49876. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter dated March 18, 1997. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported a history of cancer. _______________ PRODUCT Red Blood Cells. Recall #B-763-7. CODE Unit #21Y34370. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter dated December 13, 1996. Firm-initiated recall complete. DISTRIBUTION Oregon. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of hepatitis A. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitaed AHF. Recall #B-764/766-7. CODE Unit number #03H03346. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by letter dated January 29, 1997. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood products tested negative for the antibody to the hepatitis C virus encoded antigen (anti-HCV), but were collected from a donor who previously tested repeatedly reactive for anti-HCV. _______________ PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma. Recall #B-767/768-7. CODE Unit #03GM26308. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by telephone on September 4, 1996, followed by letter dated September 12, 1996. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor whose high risk behavior screening was inadequately performed. _______________ PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma; (c) Recovered Plasma. Recall #B-771/773-7. CODE Unit numbers: (a) 12FV38026, 12FY25986, 12FT49949, 12FP01786; (b) 12FV38026, 12FY25986, 12FT49949; (c) 12FP01786. MANUFACTURER American Red Cross, Charlotte, North Carolina. RECALLED BY Manufacturer, by letters dated on August 9-12, 1996. Firm-initiated recall complete. DISTRIBUTION North Carolina, Florida, California. QUANTITY (a) 4 units; (b) 3 units; (c) 1 unit was distributed. REASON Blood products which tested negative for the antibody to Hepatitis B core antigen (anti-HBc), but were collected from a donor who previously tested repeatedly reactive for anti-HBc. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma; (d) Recovered Plasma. Recall #B-774/777-7. CODE Unit numbers: (a) 12V77765, 12R57387; (b) 12R57387, (c) 12R57387; (d) 12V77765. MANUFACTURER American Red Cross, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated July 31, 1996. Firm-initiated recall complete. DISTRIBUTION North Carolina and California. QUANTITY (a) 2 units; (b) 1 unit; (c) 1 unit; (d) 1 unit was distributed. REASON Blood products tested negative for the antibody to Hepatitis B core antigen (anti-HBc), but were collected from a donor who previously tested repeatedly reactive for anti-HBc. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-778/780-7. CODE Unit numbers: (a) 56K35228, 56G59861, 56L06878; (b) 56G59861; (c) 56L06878. MANUFACTURER American Red Cross, Syracuse, New York. RECALLED BY Manufacturer, by letter dated on or about November 1995. Firm-initiated recall complete. DISTRIBUTION New York and California. QUANTITY (a) 3 units; (b) 1 unit; (c) 1 unit was distributed. REASON Blood products were collected from donors who tested repeatedly reactive for HBsAg. _______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-785/786-7. CODE Unit numbers: N28473, N29264. MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, Iowa. RECALLED BY Manufacturer, by letter dated August 14, 1996. Firm-initiated recall complete. DISTRIBUTION New York, New Jersey, California. QUANTITY 2 units of each component was distributed. REASON Blood products tested repeatedly reactive for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), Western Blot negative, then later reinterpreted and reported as indeterminate. _______________ PRODUCT Platelets; (b) Fresh Frozen Plasma. Recall #B-787/788-7. CODE Unit #13LG37815. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by telephone on November 5, 1996, followed by letter dated November 6, 1996. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit of each component was distributed. REASON blood products corresponded to a unit of red blood cells that was reported as clotted. _______________ PRODUCT (a) Platelets; (b) Fresh Frozen Plasma. Recall #B-790/791-7. CODE Unit #13GM03525. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by telephone on December 2, 1996. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit of each component was distributed. REASON blood products corresponded to a unit of red blood cells that was reported as having clotted segments. _______________ PRODUCT Red Blood Cells. Recall #B-794-7. CODE Unit #38FC07433. MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana. RECALLED BY Manufacturer, by letter dated January 16, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana, Florida. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who lived in an area considered endemic for malaria. _______________ PRODUCT Platelets. Recall #B-798-7. CODE Unit #FY67726. MANUFACTURER Inova Health Care Services, Annandale, Virginia. RECALLED BY Manufacturer, by letter dated November 26, 1996. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit was distributed. REASON Blood product tested repeatedly reactive for the antibody to the hepatitis C virus encoded antigen (anti-HCV). _______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-800/801-7. CODE Unit #49F91516. MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma, RECALLED BY Manufacturer, by letters dated February 5 and 12, 1997. Firm-initiated recall complete. DISTRIBUTION Oklahoma, California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor taking the drug Lupron. _______________ PRODUCT Platelet, Pheresis. Recall B-802-7. CODE Unit #0291982A1. MANUFACTURER Inland Northwest Blood Center, Spokane, Washington. RECALLED BY Manufacturer, by telephone on December 13, 1996. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY 1 unit was distributed. REASON Blood product had an extended expiration date. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-823/825-7. CODE Unit #24GV24716. MANUFACTURER American Red Cross, Louisville, Kentucky. RECALLED BY Manufacturer, by letters dated February 27 and 28, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana, California. QUANTITY 1 unit of each component was distributed. REASON Blood products which had undergone atypical viral testing for HBsAg were then tested into compliance with no confirmatory test. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======= _______________ PRODUCT Platelets, Pooled. Recall #B-412-7. CODE Unit #3N-8721, Pool #ES 0967. MANUFACTURER Puget Sound Blood Center, Seattle, Washington. RECALLED BY Manufacturer, by telephone on June 14, 1996. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY 1 unit was distributed. REASON Platelets were used in platelet pool procedures that had expired prior to pooling. _______________ PRODUCT Source Plasma. Recall #B-617-7. CODE Unit #77798B. MANUFACTURER Ohio Blood Plasma, Inc., Cincinnati, Ohio. RECALLED BY Manufacturer, by telephone on September 12, 1996. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 1 unit was distributed. REASON Blood product was not tested for syphilis. _______________ PRODUCT Red Blood Cells, Irradiated - Leukocytes Reduced. Recall #B-718-7. CODE Unit #29443-8108. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by telephone on March 10, 1997, followed by letter dated March 31, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was held at unacceptable room temperature. _______________ PRODUCT Fresh Frozen Plasma. Recall #B-737-7. CODE Unit #26147-9857. MANUFACTURER United Blood Services, Hot Springs, Arkansas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on February 5, 1997. Firm-initiated recall complete. DISTRIBUTION Arkansas. QUANTITY 1 unit. REASON Blood product was prepared from a unit of Whole Blood which may have had an extended collection time. _______________ PRODUCT Fresh Frozen Plasma. Recall #B-738-7. CODE Unit #26147-8820. MANUFACTURER United Blood Services, Fort Smith, Arkansas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated February 20, 1997. Firm-initiated recall complete. DISTRIBUTION Arkansas. QUANTITY 1 unit was distributed. REASON Blood product was not frozen within eight hours of collection. _______________ PRODUCT Red Blood Cells for further manufacture. Recall #B-740-7. CODE Unit #53GJ86771. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated January 9, 1997. Firm-initiated recall complete. DISTRIBUTION New Jersey. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. _______________ PRODUCT Platelets. Recall #B-741-7. CODE Unit numbers: 53GF06145, 53FV03956, 53FV03985, 53FV03972, 53FV03963, 53GF06126, 53GF06131, 53FH46303, 53GF06135, 53FV03983, 53FV03986, 53FV03987, 53FV03976, 53FV03977, 53FV03974, 53FV03973, 53FV03971, 53FV03968, 53FV03965, 53FV03962, 53FV03961, 53FV03960, 53FV03958, 53GF06124, 53GF06133, 53GF06136, 53GF06146, 53GF06150, 53GF06149, 53GF06148, 53GF06147, 53FV03981, 53FV03984, 53FV03975, 53FV03969, 53FV03967, 53FV03964, 53FV03959, 53FV03957, 53FH46304. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated November 1, 1995. Firm-initiated recall complete. DISTRIBUTION Maryland and District of Columbia. QUANTITY 40 units were distributed. REASON Blood products were stored at an unacceptable temperature. _______________ PRODUCT Red Blood Cells. Recall #B-746-7. CODE Unit #2370040. MANUFACTURER Central Indiana Regional Blood Center, Indianapolis, Indiana. RECALLED BY Manufacturer. Consignee returned the unit on August 27, 1995. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood product was typed as E antigen positive but labeled as E antigen negative. _______________ PRODUCT Recovered Plasma. Recall #B-758-7. CODE Unit numbers: 17033-9644, 28-29-2509, 17032-1780, 17178-2371, 28105-7910, 28105-9152, 28106-2227. MANUFACTURERS United Blood Services, San Angelo, Texas; United Blood Services, McAllen, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letters dated May 30 or 31, 1996. Firm-initiated recall ongoing. DISTRIBUTION Texas, Florida, Switzerland. QUANTITY 7 units were distributed. REASON Blood products tested negative for the antibody to the human T-lymmphotropic virus type 1 (anti-HTLV-I), but were collected from donors who previously tested repeatedly reactive for anti-HTLV-1 on two occasions. _______________ PRODUCT Red Blood Cells. Recall #B-769-7. CODE Unit numbers: 24195-2533, 21363-5602, 21363-5234. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by letter dated February 20, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 3 units. REASON Blood products, which were incorrectly tested for CMV antibody were distributed labeled as CMV negative. _______________ PRODUCT Red Blood Cells. Recall #B-770-7. CODE Unit #6157892. MANUFACTURER LifeShare Blood Centers, Beaumont, Texas. RECALLED BY Manufacturer, by telephone on December 17, 1996. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was irradiated and labeled with an extended expiration date. _______________ PRODUCT Platelets, for further manufacture. Recall #B-795-7. CODE Unit #38FC07433. MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana. RECALLED BY Manufacturer, by letter dated January 16, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana and Florida. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who lived in an area considered endemic for malaria. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========== _______________ PRODUCT Pressure monitoring kits, lines, single put-up flush devices: (a) Pressure Monitoring Kits (b) Pressure Monitoring Lines (c) Single Put-Up Flush Devices (d) Single Put-Up Monitoring Lines (e) Extension Sets (d) CDXPress Transducers. Recall #Z-572/577-7. CODE Products manufactured from 12/26 to 3/97. MANUFACTURER Medical, Argon Division, Athens, Massachusetts. RECALLED BY Maxxim Medical, Argon Division, Athens, Texas, by letter, March 28, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 338,883 items were distributed. REASON The monitoring lines are separating from connectors and flushing devices. _______________ PRODUCT LifePort Infuse-a-Port Implantable Port Systems: (a) Snap-LockTM MacroPortTM Arterial Access System, Catalog No. 39514, (b) Snap-LockTM MicroPortTM Arterial Access System, Catalog No. 39615. Recall #Z-578/579-7. CODE Lot Nos. (a) 13914, 14106, 14190, 13973, 13845; (b) 13282, 13757. MANUFACTURER Strato/Infusaid , Inc., Norwood, Massachusetts. RECALLED BY Manufacturer, by telephone between April 30, 1997 and May 1, 1997. Firm-initiated recall ongoing. DISTRIBUTION Missouri, New York, Indiana, Colorado, Massachusetts, Texas, Florida, Alabama, Connecticut, international. QUANTITY 2,927 units were distributed. REASON The catheters or ports of certain lots of arterial Infuse-a-ports may contain stainless steel spheres which could result in the metallic spheres flushing from the catheter or port. ______________ PRODUCT Renasol Acid Concentrate, hemodialysis concentrate, in .91 gallon (3.43 liter) bottles. Recall #Z-584-7. CODE Product #SB-1020, Lot #107B716. MANUFACTURER Minntech Corporation, Minneapolis, Minnesota. RECALLED BY Manufacturer, by telephone on April 4, 1997. Firm-initiated recall complete. DISTRIBUTION Maine. QUANTITY 41 cases (4 bottles per case) were distributed; firm estimates none remains on the market. REASON The immediate bottle containers were labeled, "Part A Renasol Acid Concentrate, SB-1019". The cases were properly labeled. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========= _______________ PRODUCT Radiation Oncology Computer Systems (ROCS) Treatment Planning System Software Version 5.0.X. Recall #Z-564-7. CODE Software version 5.0.X. MANUFACTURER Radiation Oncology Computer Systems, Inc., Carlsbad, California. RECALLED BY Manufacturer, by letters dated September 27, 1996, and November 6, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 248 sets of disks were distributed. REASON An error occurs when using this software version for brachytherapy dose estimations for user specified calculation points for re-oriented linear sources. _______________ PRODUCT Pinnacle Radiation Therapy Planning Software Version 2.1f. Recall #Z-565-7. CODE None. MANUFACTURER ADAC Laboratories, Milpitas, California. RECALLED BY Manufacturer, by telephone, followed by letter on February 14, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 83 tapes of the software version 2.1f were distributed. REASON Due to a software problem, the wedge scatter fields will be calculated incorrectly if the wedge filter is not square. _______________ PRODUCT Innovasive Retractor Blade (Arm), 20 mm x 80 mm, used in orthopedic procedures. Recall #Z-583-7. CODE Catalog #2513, Lot #10664. MANUFACTURER Innovasive Devices, Inc., Marlborough, Massachusetts. RECALLED BY Manufacturer, by letter dated May 2, 1997. Firm-initiated recall ongoing. DISTRIBUTION Oregon, South Carolina, Massachusetts, Texas. QUANTITY 30 units (15 sets) were distributed. REASON The arm length was found to measure 65 mm instead of the 80 mm as labeled. _______________ PRODUCT Abbott Vision CHEM Control Kit, in-vitro diagnostic. Recall #Z-585-7. CODE Control Kit, List No. 1433-02, Lot Nos. 08001M401, 08001M402. MANUFACTURER Abbott Laboratories, Diagnostics Division, Abbott Park, Illinois. RECALLED BY Manufacturer, by technical bulletin letters dated March 4, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY 2,631 kits were distributed. REASON These lots may exhibit an elevated triglyceride concentration. _______________ PRODUCT Pressure Sentinel Intramedullary Flexible Reamers: 1. Catalog No. 00-2228-005-00 2. Catalog No. 00-2228-005-05 3. Catalog No. 00-2228-006-00 4. Catalog No. 00-2228-006-05 5. Catalog No. 00-2228-007-00 6. Catalog No. 00-2228-007-05 7. Catalog No. 00-2228-008-00 8. Catalog No. 00-2228-008-05 9. Catalog No. 00-2228-009-00 10. Catalog No. 00-2228-009-05 11. Catalog No. 00-2228-010-00 12. Catalog No. 00-2228-010-05 13. Catalog No. 00-2228-011-00 14. Catalog No. 00-2228-011-05 15. Catalog No. 00-2228-012-00 16. Catalog No. 00-2228-012-05 -20- 17. Catalog No. 00-2228-013-00 18. Catalog No. 00-2228-013-05 19. Catalog No. 00-2228-014-00 20. Catalog No. 00-2228-014-05 21. Catalog No. 00-2228-015-00 22. Catalog No. 00-2228-015-05 23. Catalog No. 00-2228-016-00 24. Catalog No. 00-2228-016-05 25. Catalog No. 00-2228-017-00 26. Catalog No. 00-2228-017-05 27. Catalog No. 00-2228-018-00 28. Catalog No. 00-2228-018-05 29. Catalog No. 00-2228-019-00 30. Catalog No. 00-2228-019-05 31. Catalog No. 00-2228-020-00 32. Catalog No. 00-2228-020-05 33. Catalog No. 00-2228-021-00 34. Catalog No. 00-2228-021-05 35. Catalog No. 00-2228-022-00. Recall #Z-590/624-7. CODE All lot numbers. MANUFACTURER Zimmer, Inc., Warsaw, Indiana. RECALLED BY Manufacturer, by E-mail on February 7, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Canada, Singapore. QUANTITY Approximately 1,285 units were distributed. REASON Cracks were found on the cutting tips. END OF ENFORCEMENT REPORT FOR MAY 28, 1997. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for