February 18, 1998 98-07 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Powerade 64 ounce Lemon-Lime with jagged ice labels. Recall #F-251-8. CODE 7343CC. MANUFACTURER The Minute Maid Company, for Coca-Cola at United Packers, Inc., Chattanooga, Tennessee. RECALLED BY Coca Cola USA Operations, Atlanta, Georgia by fax on January 23, 1998. Firm-initiated recall ongoing. DISTRIBUTION Alabama, California, Connecticut, Florida, Georgia, Louisiana, Massachusetts, Mississippi, North Carolina, Ohio, South Carolina, Tennessee, Virginia. QUANTITY 9,352 cases (8 bottles per case) were distributed. REASON Product contain undeclared FD&C Yellow No. 5. _______________ PRODUCT Star Market brand White Corn Tortilla Chips, packed in 10 ยด oz. bags. Recall #F-252-8. CODE Product codes: SEPTD22; NOV10D; and NOV24C. MANUFACTURER Keystone Food Products, Inc., Easton, Pennsylvania. RECALLED BY Manufacturer, by letter on October 24, 1997. Firm-initiated recall ongoing. DISTRIBUTION New England states. QUANTITY Firm estimates none remains on the market. REASON The product is contaminated with cheese curls that contain dairy ingredients, monosodium glutamate, FD&C Yellow 5 Lake & FD&C Yellow 6 Lake, which are not declared on the tortilla chips labeling. _______________ PRODUCT Canned Kippered Snacks manufactured between May 26 and August 5, 1997: a) Kippered Snacks Herring in Dijon Mustard Sauce under the Brunswick label b) Kippered Snacks Herring in Louisiana Hot Sauce under the Brunswick label c) Kippered Snacks Golden Smoked Herring under the Brunswick label d) Kippered Snacks Herring under the following labels: Brunswick, Viking Delight, Season, King Oscar, Spirit of Norway, and Western Family e) Kippered Snacks Herring, No Salt Added under the Season label. Recall #F-253/257-8. CODE Codes are embossed on the lids of cans in addition to being printed on the outer case. Each can is overwrapped, code is not visible on cans unless overwrap is removed. Brunswick Brands: Dijon Mustard: (yellow wrapper UPC 66613-16906) Case Code: 7X1160, 7X2160, 7X1161, 7X2161, 7X1163, 7X2163, 7X1211, 7X2211, 7X1212, 7X2212 Can Code: I7X1160D, I7X2160D, I7X1161D, I7X2161D, I7X1163D, I7X2163D, I7X1211D, I7X2211D, I7X1212D, I7X2212D Louisiana Hot Sauce: (orange wrapper UPC 66613-19306) Case Code: 7X1156, 7X2156, 7X1157, 7X2157, 7X1162, 7X2162, 7X1195, 7X2196, 7X1196, 7X2196, 7X1197, 7X2197, 7X1211, 7X2211 Can Code: I7X1156L, I7X2156L, I7X1157L, I7X2157L, I7X1162L, I7X2162L, I7X1195L, I7X2195L, I7X1196L, I7X2196L, I7X1197L, AISLE, I7X1211L, I7X2211L Herring Kippered Snacks (Regular) (UPC 66613-17506) Case Code: 7X1147, 7X2147, 7X1148, 7X2148, 7X1150, 7X2150, 7X1153, 7X2153, 7X1163, 7X2163, 7X1164, 7X2164, 7X1168, 7X2168, 7X1169, 7X2169, 7X1170, 7X2170, 7X1171, 7X2171, 7X1174, X2174, 7X1175, 7X1175, 7X2175, 7X1176, 7X2176, 7X1177, 7X2177, 7X1178, 7X2178, 7X1182, 7X2182, 7X1183, 7X2183, 7X1184, 7X2184, 7X1185, 7X2185, 7X1189, 7X2189, 7X1190, 7X2190, 7X1191, 7X2191, 7X1213, 7X2213 Can Code: I7X1147R, I7X2147R, I7X1148R, I7X2148R, I7X2148R, I7X1150R, I7X2150, I7X1153R, I7X2153R, 17X1163R I7X2163R, I7X1164R, I7X2164R, I7X1168R, I7X2168R, I17X2169, I7X1170R, I7X2170R, I7X1171R, I7X2171R, I7X1174R, I7X2174R, I7X1175R, I7X2175, I7X1176R, I7X2176R, I7X1177R, I7X2177R, I7X1178R, I7X2178R, I7X1182R, I7X2182R, I7X1183R, I7X2183R, I7X1184R, I7X2184R, I7X1185R, I7X2185R, I7X1189R, I7X2189R, I7X1190R, I7X2190R, I7X1191R, I7X2191R, I7X1213R, I7X2213R Golden Smoked (UPC 66613-18106) Case code: 7X1188, 7X2188, 7X1192, 7X2192, 7X1196, 7X2196, 7X1197, 7X2197, 7X1198, 7X2198, 7X1199, 7X2199, 7X1202, 7X2202, 7X1205, 7X2205, 7X1206, 7X2206, 7X1210, 7X2210, 7X1212, 7X2212, 7X1213, 7X2213 Can Code: J7X1188S, J7X2188S, J7X1192S, J7X2192S, J7X1196S, J7X2196S, J7X1197S, J7X2197S, J7X1198S, J7X2198S, J7X1199S, J7X2199S, J7X1202S, J7X2202S, J7X1205S, JX2205S, J7X1206S, J7X2206S, J7X1210S, 7X2210S, J7X1212S, J7X2212S, J7X1213S, J7X2213S Private Label: Viking Delight Kippered Snacks (UPC 73196-00350) Case Code: 7X1197S, 7X2197 Can Code: J7X1197S, J7X2197S Season Kippered Snacks, No Salt Added (UPC 70303-02485) Case Code: 7X1188, 7X2188, 7X1189, 7X1189, Can Code: J7X1188Z, J7X2188Z, J7X1189Z Season Kippered Snacks (UPC 70303-02388) Case Code: 7X2189, 7X1190, 7X2190, 7X1191, 7X2191 Can Code: J7X2189Z, J7X1190S, J7X2190S, J7X1191S, J7X2191S King Oscar Kippered Snacks (UPC 71140-00400) Case Code: 7X2197,7X1198, 7X2198, 7X1199, 7X2199, 7X1206, 7X2206, 7X1195, 7X2195 Can Code: J7X2197S, J7X1198S, J7X2198S, J7X1199S, J7X2199S, J7X1206S, J7X2206S, J7X1195S, J7X2195S Spirit of Norway Kippered Snacks (UPC 71140-00345) Case Code: 7X1195, 7X1211, 7X2195, 7X2209 Can Code: J7X1195S, J7X1211S, J7X2195S, J7X2209S Western Family Kippered Snacks (UPC 15400-03586) Case Code: 7X1183 and 7X2183 Can Code: I7X1183R and I7X2183R. MANUFACTURER Connors Brothers, Ltd., New Brunswick, Canada. RECALLED BY Connors Brothers, Inc., So. Portland, Maine (importer), by fax on September 4, 1997 followed by letter. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 63,233 cases of 18 and 4,081 cases of 24 were distributed. REASON Some of the product was packed in defective cans which could not preserve the integrity of the product. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III =========== _______________ PRODUCT Gliadel Wafer (Polifeprosan 20 with Carmustine Implant), 7.7 mg carmustine/wafer, in units of 8 wafers individually packaged, Rx indicated for use as a adjunct to surgery to prolong survival in patients with recurrent glioblastoma multiform for whom surgical resection is indicated. NDC #IS 0075-9995-0107. Recall #D-065-8. CODE Lot #K97A1. MANUFACTURER Guilford Pharmaceuticals, Inc., Baltimore, Maryland. RECALLED BY Rhone Poulenc Rorer Pharmaceuticals, Inc., Collegeville, Pennsylvania, by telephone on December 12, 1997, followed by letter dated December 16, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 41 units (8 wafers each) and 17 partial units (less than 8 wafers) remained on market at time of recall initiation. REASON Excess breakage of wafers. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======== _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Plasma; d) Source Leukocytes. Recall #B-534/537-8. CODE Unit #53GN08468. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated October 28, 1997. Firm-initiated recall complete. DISTRIBUTION Maryland and New Jersey. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported that arm cleansing was not performed prior to venipuncture. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma. Recall #B-538/541-8. CODE Unit a) 40GR62762, 40GR67544, 40GS72959, 40GS76514, 40GR83691, 40GS87090, 40GV70465, 40GS98427, 40GR01028, 40GS11608, 40GF05377, 40LR04051, 40GK07515; b) 40GS98427, 40GR01028 c) 40GS11608; d) 40GR62762, 40GR67544, 40GS72959, 40GS76514, 40GR83691, 40GS87090, 40GV70465, 40GS98427, 40GR01028, 40GF05377, 40LR04051, 40GK07515. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by letters dated September 1, 1997, October 1 and 24, 1997, December 31, 1997, or January 8, 1998. Firm-initiated recall complete. DISTRIBUTION Illinois, Iowa, Mississippi, Tennessee, California. QUANTITY a) 13 units; b) 2 units; c) 1 unit; d) 12 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 and was subjected to additional retesting. _______________ PRODUCT Platelets, Pheresis. Recall #B-547-8. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by letters dated September 1, 1997, and October 1, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois, Mississippi, Massachusetts. QUANTITY 51 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. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Plasma; d) Recovered Plasma. Recall #B-550/553-8. CODE Unit numbers: a) 53FR20337, 53T59552, 53L99552, 53J07133, 53J02113, 53G15103, 53J91857, 53G49232 b) 53FR20337, 53J02113, 53J91857 c) 53J91857; d) 53FR20337, 53T59552, 53J07133, 53J02113, 53G15103, 53G49232. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter or fax on July 24, 1997 or July 16, 1997. Firm-initiated recall complete. DISTRIBUTION Maryland, New York, California. QUANTITY a) 8 units; b) 3 units; c) 1 unit; d) 6 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, and was reentered incorrectly. _______________ PRODUCT Platelets, Pheresis. Recall #B-561-8. CODE Unit #11317-9887. MANUFACTURER United Blood Services, El Paso, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on January 1, 1998. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======= _______________ PRODUCT Fresh Frozen Plasma. Recall #B-524-8. CODE Unit #10523-9031. MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on January 28, 1997. Firm-initiated recall complete. DISTRIBUTION Arizona. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of Whole Blood which may have had an extended collection time. _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-532/533-8. CODE Unit numbers: 4764334, 4764335, 4764336, 4764337, 4764339, 4764345, 4764347, 4764348, 4764349, 4764350, 4764354, 4764357, 4764359, 4592343. MANUFACTURER National Naval Medical Center, Bethesda, Maryland. RECALLED BY Manufacturer, by telephone on February 8, 1996. Firm-initiated recall complete. DISTRIBUTION District of Columbia. QUANTITY 14 units of each component were distributed. REASON Blood products were incorrectly tested for the hepatitis B surface antigen (HbsAg). _______________ PRODUCT Red Blood Cells. Recall #B-546-8. CODE Unit #05X72675. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated September 29, 1997, and November 4, 1997. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 unit was distributed. REASON Blood product tested initially reactive for the hepatitis B surface antigen (HBsAg), and had no retesting performed. _______________ PRODUCT a)Reagent Red Blood Cells Ortho Coombs Control; b) Reagent Red Blood Cells Surgiscreen. Recall #B-554/555-8. CODE Lot numbers: a) K222; b) 3SS790. MANUFACTURER Ortho Diagnostic Systems, Inc., Raritan, New Jersey. RECALLED BY Manufacturer, by letter dated May 13, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide and Japan. QUANTITY a) 1,028 kits; b) 225 kits were distributed. REASON Red Blood Cells were found to exhibit hemolysis. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========== _______________ PRODUCT Normal Saline Syringe, disposable, polypropylene, piston-type syringe. Recall #Z-297-8. CODE Catalog #: RAS-03-06, Lot #: 5061-0417-1133, EXP 10/17/97. MANUFACTURER ROCAP, Woburn, Massachusetts. RECALLED BY ROCAP, Inc., Orlando, Florida, by telephone beginning May 29, 1997. Firm-initiated recall complete. DISTRIBUTION Connecticut, Illinois, Maryland, Pennsylvania. QUANTITY 960 syringes were distributed. REASON Normal saline syringe was labeled as: 0.9% Sodium Chloride, USP, 3.0 ml fill in 6.0 ml syringes. However, the product was filled into 3.0 ml syringes instead of 6.0 ml syringes making the syringe size incorrect. _______________ PRODUCT Normal Saline Syringe, disposable polypropylene, piston-type syringe. Recall #Z-298-8. CODE Catalog #: RAS-01-03, Lot #: 5001-0516-1027, EXP 11/16/97. MANUFACTURER ROCAP, Woburn, Massachusetts. RECALLED BY ROCAP, Orlando, Florida, by telephone July 24, 1997. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 960 syringes were distributed. REASON Normal saline syringe was labeled as: 0.9% Sodium Chloride, USP, 1.0 ml fill in 3.0 ml syringes. However, the fill volume of the product was incorrect since it was actually filled with 3.0 ml of 0.9% Sodium Chloride, USP. _______________ PRODUCT Normal Saline Syringe, disposable polypropylene, piston-type syringe. Recall #Z-299-8. CODE Catalog #: RAS-01-03, Lot #: 5001-0507-1234, EXP 11/07/97 MANUFACTURER ROCAP, Inc., Woburn, Massachusetts. RECALLED BY ROCAP, Inc, Orlando, Florida, by telephone on August 29, 1997. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 960 syringes were distributed. REASON Normal saline syringe was labeled as: 0.9% Sodium Chloride, USP, 1.0 ml fill in 3.0 ml syringes. However, the fill volume of the product was incorrect since it was actually filled with 3.0 ml of 0.9% Sodium Chloride, USP. _______________ PRODUCT IVAC Space Saver Volumetric Infusion Pumps: a) Model 597; b) Model 598; c) Model 599. Recall #Z-300/302-8. CODE All serial numbers. MANUFACTURER Alaris Medical Systems, Inc. (formerly IVAC Corp.), San Diego, California. RECALLED BY Alaris Medical Systems, Inc., San Diego, California, by letter dated April 11, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY Approximately 28,000 units were distributed. REASON The devices are subject to over infusion due to the wear of the camming surfaces, causing the opening of the IV tubing to become smaller, therefore, reducing the loading gap. _______________ PRODUCT Techstar XL 6 French Percutaneous Vascular Surgery Device (PVS), indicated for the percutaneous delivery of sutures for closing the common femoral artery access site of patients who have undergone diagnostic catherization procedures using 5 to 6 Fr. Sheaths: a) Catalog No. TXL-431-06; b) Catalog No. TXLS-432-06. Recall #Z-311/312-8. CODE 1563 1641 1713 1720 1776 1564 1700 1714 1722 1778 1632 1704 1717 1727 1779 1634 1705 1718 1774 1497 1565 1671 1673 1711 1060 1091 1130 1363 1369 1559 1062 1093 1135 1364 1552 1561 1063 1102 1143 1366 1552 1068 1089 1107 1362 1367 1557 1098. MANUFACTURER Perclose, Inc., Menlo Park, California. RECALLED BY Manufacturer, by letter faxed on November 22, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 3,933 units were distributed. REASON The product was manufactured with out-of- specification components. _______________ PRODUCT Cobe-Gambro-Hospal brand Acid Concentrate for Bicarbonate Dialysis, Product #BAC-403X. Recall #Z-325-8. CODE 715605C, 716201C, 720307C, 723401C, 724802C. MANUFACTURER Gambro Healthcare, Deland, Florida. RECALLED BY Manufacturer, by letter on October 17, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 2,383 cases were distributed. REASON The acid concentrate label incorrectly identifies the magnesium and chloride concentration. _______________ PRODUCT Opteon brand Femoral Stems, indicated for use in skeletally mature individuals undergoing primary or secondary surgery for proximal femoral fractures where prosthetic replacement is determined by the surgeon to be the preferred treatment. Recall #Z-326-8. CODE All lots manufactured prior to 9/22/97. MANUFACTURER Exatech, Inc., Gainesville, Florida. RECALLED BY Manufacturer, by telephone on September 22, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide and Argentina. QUANTITY 608 stems were distributed. REASON The device is subject to fracture (breakage) near the laser "alignment" marking. _______________ PRODUCT Sterile ENT Knives and Burs in a plastic tray with lids and sealed in a primary peep pouch: a) MICRO ENT KNIVES, List No. A907060, Model Nos. 14-58230, 14-58231, 14-58232, 14-58234; b) MICRO-CRAFT AND HELIX BURS, List No. A871727, Model Numbers with the following common prefixes: "31-xxxx" and "9xxx-++". Recall #Z-327/328-8. CODE a) All lots manufactured from August 11, 1997 to November 6, 1997; b) All lots manufactured from August 11, 1997 to November 6, 1997. MANUFACTURER Xomed Surgical Products, Inc., Jacksonville, Florida. RECALLED BY Manufacturer, by letter on November 12, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY Approximately 22,856 units were distributed. REASON The sterility of the devices has been compromised as evidenced by loss of package integrity. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========= _______________ PRODUCT Triumph Vascular Access Ports: a) SSA-16-I Triumph 1 Vascular Access Ports, B) 8 SSD-16-I Triumph Vascular Access Ports. RECALL #Z-293/294-8. CODE Lot numbers: a) 50717D; b) 524126B. MANUFACTURER ACT Medical, Inc., Walthlam, Massachusetts. RECALLED BY Horizon Medical Products, Inc., Manchester, Georgia, by telephone on February 21, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY a) 39 ports; b) 166 ports were distributed. REASON The devices were packaged with a size 8 French Introducer instead of size 10 French Introducer as labeled. _______________ PRODUCT Bartels Toxi-Titer Diluent, in-vitro diagnostic, Catalog #B1029-70B. Recall #Z-324-8. CODE Lot #7M375-2. MANUFACTURER Bartels, Inc., Issawuah, Washington. RECALLED BY Manufacturer, by fax and by telephone on January 28, 1998. Firm-initiated recall complete. DISTRIBUTION Colorado, Illinois, Oklahoma, Oregon, Pennsylvania, Wisconsin. QUANTITY 18 units were distributed. REASON Bacterial contamination. _______________ PRODUCT 2-0 Chromic Gut Suture (3.5 Metric), DT-12 37mm 27" 67 cm), Sterile, Type C, Absorbable, Surgical Suture USP, Diamond Point. Recall #Z-313-8. CODE Lot #951824. MANUFACTURER Sherwood-Davis & Geck, Manati, Puerto Rico. RECALLED BY Sherwood-Davis & Geck, Hazelwood, Missouri, by letter dated December 16, 1997, followed by visit. Firm-initiated recall ongoing. DISTRIBUTION New York, Illinois, Connecticut, Louisiana, Puerto Rico, Georgia. QUANTITY 59 cartons were distributed. REASON Some of the foil envelopes containing the sutures were labeled Chromic Gut Size 3-0 but actually contained size 2-0. END OF ENFORCEMENT REPORT FOR FEBRUARY 18, 1998. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for