October 11, 2000 00-41RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT Pat Vidor's chocolate Chip Cookies, net weight 7 ounces. Recall #F-836-0. CODE All codes on the market at time of recall initiation. MANUFACTURER Taylor Street Ovens, Corvallis, Oregon. RECALLED BY Manufacturer, by telephone on August 21, 2000. Firm-initiated field correction (relabeling) complete. DISTRIBUTION Oregon. QUANTITY 15 packages at retail level at time of recall initiation. REASON Product contained undeclared walnuts. ________ PRODUCT Scobee Deli Chicken Salad Sandwich, 5 ounces; and Express Deli Chicken Salad Sandwich, 4.5 ounces. Recall #F-001-1. CODE Sell by date 071400 and 072100. MANUFACTURER Scobee Foods, Inc., Mesquite, Texas. RECALLED BY Manufacturer, by telephone on June 28, 2000, and by press release on June 30, 2000. Firm-initiated recall complete. DISTRIBUTION Michigan, Illinois, Wisconsin, Ohio, Kentucky, Indiana, Texas. QUANTITY Approximately 12,000 sandwiches. REASON Sandwiches may be contaminated with Listeria monocytogenes.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT Fierce Lime Gatorade Thirst Quencher, in 32-fluid ounce Plastic bottles. Recall #F-834-0. CODE Cap code: T28H0x3xx:xx Case code: 12-32 OZ PLASTIC FIERCE LIME 32073 AUG-28-00 T x xx:xx xxxxx The "x"s indicate the shift, time, and case number which can be ignored. MANUFACTURER The Quaker Oats Company, Dallas, Texas. RECALLED BY The Quaker Oats Company, Chicago, Illinois, by telephone on September 19- 20, 2000. Firm-initiated recall ongoing. DISTRIBUTION Kansas, Oklahoma, Texas, New Mexico, Missouri, Colorado, Arkansas, Ohio, Louisiana, Nebraska and Mississippi. QUANTITY Approximately 14,300 cases (12 bottles per case) were distributed. REASON Product was contaminated with mold.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______ PRODUCT BC(r) brand Headache Powder (650 mg Aspirin, 195 mg Salicylamide, 33.3 Caffeine), packaged in 2's NDC# 1015800908, packaged in 6's NDC# 1015800910, packaged in 24's NDC# 1015800912, packaged in 50's NDC# 1015800916. Recall#D-457-0. CODE Lot Numbers: M000580, M000581, M000582, M000583, M000857, M000858, M000859, M000860, M000861, M000862, M000863, M000864, M000865, M000866, M001703, M001704, M001705, M001706, M001707, M001708, M001709, M001710, M001711, M001712, M002205, M002206, M002207, M002208, M002209, M002210, M002211, M002212, M002213, M002214, M002771, M002772, M002773, M002774, M002780, M002903, M002904, M002905, M002906, M002907, M002908, M002909, M002910, M002911, M002912, M003265, M003390, M003391, M003392, M003393, M003394, M003395, M003396, M003397, M003398, M003420, M003428, M003429, M003430, M003431, M003432, M003433, M003434, M003435, M003436, M003437, M004001, M004049, M004050, M004051, M004052, M004053. MANUFACTURER Block Drug Company, Memphis, Tennessee. RECALLED BY Block Drug Company, Jersey, City, New Jersey, by letter on May 30, 2000, and June 23, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY BC Powder 2"s ---316,714/60dz BC Powder 6's ----180,232/60dz BC Powder 24's ----1,806/3dz BC Powder 50's ----18,188/3dz were distributed. REASON Discoloring of glassine envelopes holding product. _______ UPDATE Jordan's Epinephrine Injection, USP, 1:1000, 1mg/mL, in 1 mL ampuls, which appeared in the May 24, 2000 Enforcement Report should have been listed as follows: Class II -- Recall #D-349-0, Lot Numbers: 980308, 980401, 980501, 980601, 990205; and Class III -- Recall #D-350-0, Lot Numbers: Lot Numbers: 980402, 990307, 990308.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT a) Red Blood Cells, Irradiated; b) Platelets, Irradiated. Recall #B-869/870-0. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by letter dated May 31, 2000. Firm-initiated recall complete. DISTRIBUTION Virginia and Maryland. QUANTITY a) 1,411 units; b) 463 units were distributed. REASON Blood products, for which there is no documentation of the time of the products were returned to controlled storage temperatures, were distributed. ________ PRODUCT Cornea. Recall #B-1010-0. CODE 2000-201C. MANUFACTURER Lions Eye Bank for Long Island, Manhasset, New York. RECALLED BY Manufacturer, by telephone on August 18, 2000, and by letter dated August 17, 2000. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 unit was distributed. REASON Cornea was collected from a donor who tested repeatedly reactive for the antibody to the Hepatitis B core antigen (anti-HBc), non-confirmable by PCR. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1165/1166-0. CODE Unit #38FC44906. MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana. RECALLED BY Manufacturer, by letter and telephone on June 1, 1999. Firm-initiated recall complete. DISTRIBUTION Indiana and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported a history of hepatitis. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1167/1168-0. CODE Unit #38E72100. MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana. RECALLED BY Manufacturer, by letter dated June 15, 1998. Firm-initiated recall complete. DISTRIBUTION Michigan and Ohio. 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-1169-0. CODE Unit #13W92939. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by letter dated September 3, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product was collected from a door who traveled to an area considered endemic for malaria. ________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Double Unit. Recall #B-1187-0. CODE Unit #3350538. MANUFACTURER Florida Blood Services, St. Petersburg, Florida. RECALLED BY Manufacturer, by telephone on December 16, 1997. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product was labeled with incorrect platelet yields. ________ PRODUCT Red Blood Cells. Recall #B-1188-0. CODE Unit #3138262. MANUFACTURER Florida Blood Services, St. Petersburg, Florida. RECALLED BY Manufacturer, by telephone and letter on March 11, 1997. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose body temperature had not been documented. ________ PRODUCT Source Plasma. Recall #B-1217-0. CODE Unit Numbers: 07504945, 07503429, 07502620. MANUFACTURER Plasma Biological Services, Inc., Asheville, North Carolina. RECALLED BY Interstate Blood Bank, Inc., Memphis, Tennessee, by fax on April 26, 1999. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 3 units were distributed. REASON Blood products were collected from a donor who had body piercing within twelve months of donation. ________ PRODUCT Red Blood Cells. Recall #B-1223-0. CODE Unit #38FK03420. MANUFACTURER American Red Cross Great Lakes Region, Fort Wayne, Indiana. RECALLED BY Manufacturer, by letter on May 25, 1999. Firm-initiated recall complete. DISTRIBUTION Indiana. 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 Cryoprecipitated AHF. Recall #B-1224-0. CODE Unit Numbers: 3155759, 3155727, 3155761, 3156704, 3155764, 3330058, 3356874, 3156718, 3157724, 3156714, 3326875, 3156705, 3157706, 3339870, 3186493, 3352521, 3352513, 3352524, 3803089, 3330055, 3187917, 3347502, 3188270, 3803080, 3352424, 3157726, 3187920. MANUFACTURER Florida Blood Services, St. Petersburg, Florida. RECALLED BY Manufacturer, by telephone and letter on April 30, 1998. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 27 units were distributed. REASON Blood products were not frozen within the acceptable time limit. ________ PRODUCT Red Blood Cells. Recall #B-1260-0. CODE Unit Numbers: 12LE73325 and 12L47287. MANUFACTURER American Red Cross Blood Services, Winston Salem, North Carolina. RECALLED BY American Red Cross Blood Services, Charlotte, North Carolina, by letter dated February 9, 2000. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor taking the drug Arava. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Cryoprecipitated AHF; e) Recovered Plasma. Recall #B-1268/1272-0. CODE Unit Numbers: a) 3163429, 3176259, 3136116, 3308309, 3316150, 3329126, 3342262, 9109256, 3417590, 3444243, 3456197, 3472818, 3324773, 3421480, 3450727, 3129559, 3151156, 3323891, 3144615, 3173389, 3449581, 3311998, 3457202, 3490183, 3480664, 3150862, 3168696, 3176358, 3472952, 3156453, 3187799; b) 3842844, 3136116, 3308309, 3316150, 9109256, 3472818, 3324773, 9726114a, 9726114b, 9726331, 3406718, 3417274, 3424156, 3439368, 3129559, 3314409, 3173389, 3151355a, 3151355b, 3153776, 3449581, 3311998; c) 3421480, 3150862, 3150560, 3329126, 3450727, 3311998, 9109256, 3323891; d) 3490183, 3150560, 3427162; e) 3142341, 3163429, 3842844, 3136116, 3308309, 3316150, 3342262, 3417590, 3444243, 3456175, 3472818, 3324773, 3129559, 3151156, 3314409, 3321738, 3144615, 3173389, 3419729, 3457202, 3490183, 3427162, 3444690, 3480664, 3168696, 3176358, 3472952, 3156453, 3187799. MANUFACTURER Florida Blood Services, St. Petersburg, Florida. RECALLED BY Manufacturer, by telephone and letters from May 15, 1998 through October 1, 1998. Firm-initiated recall complete. DISTRIBUTION Florida, Virginia, New York. QUANTITY a) 31 units; b) 22 units; c) 8 units; d) 3 units; e) 29 units were distributed. REASON Blood products tested negative for syphilis, but were collected from donors who previously tested reactive for syphilis by confirmatory testing. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1273/1274-0. CODE Unit #2272081. MANUFACTURER Central Texas Regional Blood & Tissue Center, Austin, Texas. RECALLED BY Manufacturer, by letter dated October 27, 1999. Firm-initiated recall complete. DISTRIBUTION Tennessee and Florida. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor whose sex partner lived in an HIV group O risk area. ________ PRODUCT Red Blood Cells. Recall #B-1275-0. CODE Unit Numbers: 62-41602 and 62-38663. MANUFACTURER Saginaw Valley Blood Program, Saginaw, Michigan. RECALLED BY Michigan Community Blood Centers, Grand Rapids, Michigan, by letter on October 5, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. 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 Red Blood Cells. Recall #B-1276-0. CODE Unit #17KW04966. MANUFACTURER American Red Cross, North Central Blood Services, St. Paul, Minnesota. RECALLED BY Manufacturer, by letter dated December 27, 1999. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. 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-1277-0. CODE Unit #38-31785. MANUFACTURER Saginaw Valley Blood Program, Saginaw, Michigan. RECALLED BY Michigan Community Blood Centers, Grand Rapids, Michigan, by letter on December 30, 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-1278-0. CODE Unit #62-44493. MANUFACTURER Saginaw Valley Blood Program, Saginaw, Michigan. RECALLED BY Michigan Community Blood Centers, Grand Rapids, Michigan, by letter on January 13, 2000. 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-1279-0. CODE Unit #18FK21636. MANUFACTURER American Red Cross, Lansing, Michigan. RECALLED BY Manufacturer, by letter on August 6, 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 a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-1280/1281-0. CODE Unit #3026574. MANUFACTURER Florida Blood Services, St. Petersburg, Florida. RECALLED BY Manufacturer, by fax on October 22, 1999. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit of each component was distributed. REASON Blood products had invalid test results for HBsAg or HIV-1 p24 Antigen. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1283/1284-0. CODE Unit #18FE43211. MANUFACTURER American Red Cross, Lansing, Michigan. RECALLED BY Manufacturer, by letter on November 19, 1997. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1285/1286-0. CODE Unit Numbers: a) 0344068, 0344070, 0344072, 0344079, 0344087, 0344097, 0344098, 0974626, 0974627, 0974628, 0974629, 0974630, 0974631, 0974632, 0974633, 0974634, 0974635, 0974636; b) 0344070 and 0344087. MANUFACTURER Community Blood Bank of Erie County, Erie, Pennsylvania. RECALLED BY Manufacturer, by letter dated August 21, 2000. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY a) 18 units; b) 2 units were distributed. REASON Blood products were incorrectly tested for anti-HBc. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma. Recall #B-1287/1290-0. CODE Unit Numbers: a) 7223446, 7225814, 7226924; b) 7223446, 7225814, 7226924; c) 7225814; d) 7223446, 7226924. MANUFACTURER Manatee Community Blood Center, Inc., Bradenton, Florida. RECALLED BY Manufacturer, by telephone and letter on September 21, 1998. Firm- initiated recall complete. DISTRIBUTION Florida. QUANTITY a) 3 units; b) 3 units; c) 1 unit; d) 2 units were distributed. REASON Blood products were collected from a donor who was not deferred after reporting a needlestick. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1291/1292-0. CODE Unit #13L94167. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by letter dated March 2, 2000. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit 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-1293/1294-0. CODE Unit #36GQ18476. MANUFACTURER American Red Cross Blood Services, Columbia, South Carolina. RECALLED BY Manufacturer, by letter dated June 15, 1999. Firm-initiated recall complete. DISTRIBUTION South Carolina. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor who reported taking antibiotics for a sore throat. ________ PRODUCT Red Blood Cells. Recall #B-1297-0. CODE Unit #18FQ55394. MANUFACTURER American Red Cross, Lansing, Michigan. RECALLED BY Manufacturer, by letter dated April 19, 2000. 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 Platelets. Recall #B-1300-0. CODE Unit #65-47098. MANUFACTURER Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, Michigan. RECALLED BY Manufacturer, by telephone on January 17, 2000, followed by letter dated March 5, 2000. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product was distributed after receiving information concerning a post donation illness.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Red Blood Cells. Recall #B-1182-0. CODE Unit #1667091. MANUFACTURER Central Kentucky Blood Center (CKBC), Lexington, Kentucky. RECALLED BY Manufacturer, by telephone on May 3, 2000. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. ________ PRODUCT Platelets Pheresis, Double Units. Recall #B-1186-0. CODE Unit Numbers: 3552481, 3552473, 3391789. MANUFACTURER Florida Blood Services, Tampa, Florida. RECALLED BY Florida Blood Services, St. Petersburg, Florida, by fax on April 27, 1999. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 3 double units were distributed. REASON Unlicensed blood products were distributed in interstate commerce. ________ PRODUCT Fresh Frozen Plasma. Recall #B-1259-0. CODE Unit #7617111. MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana. RECALLED BY Manufacturer, by telephone on December 9, 1999. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit was distributed. REASON Unlicensed blood product was distributed in interstate commerce. ________ PRODUCT Red Blood Cells. Recall #B-1282-0. CODE Unit Numbers: 3029708, 3050047, 3027134, 3027137, 3052590. MANUFACTURER Florida Blood Services, St. Petersburg, Florida. RECALLED BY Manufacturer, by fax on October 22, 1999. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 5 units were distributed. REASON Blood products had invalid test results for HBsAg or HIV-1 p24 Antigen. ________ PRODUCT PK7100 and PK7200 CMV-PA Automated Blood Grouping Analyzer CMV Test System and Controls: Olympus PK7100 Automated Blood Grouping System, Product Code 81KSZ; Olympus PK7200 Automated Microplate System, Product Code 81KSZ; Olympus PK CMV-PA Cytomegalovirus serological reagents, Product Code MZE. Recall #B-1295-0. CODE All lot and serial numbers are affected. MANUFACTURER PK7100 & PK7200 Automated Analyzer: Olympus Optical Co., Ltd., Tokyo, Japan PK CMV-PA Systems and Controls: Fujirebio America, Inc., Fairfield, New Jersey; Fujirebio, Inc., Tokyo, Japan; SCIMEDIX Corp., Denville, New Jersey. RECALLED BY Olympus America, Inc., Irving, Texas (distributor), by letter dated July 17, 2000. Firm-initiated recall ongoing. DISTRIBUTION North Carolina, California, Louisiana, Florida, Kentucky, Virginia, Illinois, Tennessee, Oklahoma, Canada. QUANTITY PK7100: 2 analyzers; PK7200 38 analyzers were distributed. 412,000 tests per month were distributed. REASON Automated test systems, which may have produced incorrect CMV antibody test results. ________ PRODUCT Red Blood Cells. Recall #B-1296-0. CODE Unit #21KC05728. MANUFACTURER American Red Cross Blood Services, Pacific Northwest Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by telephone on March 29, 2000, followed by letters dated April 12, 2000, and May 22, 2000. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. ________ PRODUCT Red Blood Cells, Autologous. Recall #B-1298-0. CODE Unit Numbers: 00-81738, 00-81739, 23-40650, 29-01391, 29-01392, 52-00660, 52-00661, 52-00663. MANUFACTURER Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, Michigan. RECALLED BY Manufacturer, by letter dated January 21, 2000. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 8 units were distributed. REASON Blood products were labeled with extended expiration dates. ________ PRODUCT Red Blood Cells. Recall #B-1299-0. CODE Unit #38-32919. MANUFACTURER Saginaw Valley Blood Program, Saginaw, Michigan. RECALLED BY Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, Michigan, by letter dated October 18, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product was received at an unacceptable temperature.RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
________ PRODUCT Datex-Ohmeda AS/3 Anesthesia Delivery Unit (ADU), a complete anesthesia delivery unit with electronically controlled ventilator, gas delivery and agent vaporizing units. Recall #Z-004-1. CODE Serial Numbers: 40022203 and above. MANUFACTURER Datex-OHMEDA, Inc., Tewksbury, Massachusetts. RECALLED BY Manufacturer, by voice mail on April 28, 2000, followed by visit beginning May 5, 2000. Firm-initiated field correction ongoing. DISRIBUTION Nationwide and international. QUANTITY 1,150 units were distributed. REASON The device has reliability problems with fresh gas delivery, agent delivery and ventilation functions.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT CeeOn Intraocular Lens, heparin surface modified IOL. Recall #Z-002-1. CODE Model 727C, Lot Numbers: 5448, 5450, 5451, 5452, 5453, 5454, 5455, 5456, 5458, 5459, 5460, 5462, 5464, 5466. MANUFACTURER Pharmacia & Upjohn Groningen BV, Groningen, Netherlands. RECALLED BY Pharmacia & Upjohn Company, Kalamazoo, Michigan, by telephone on August 10, 2000. Firm-initiated recall complete. DISTRIBUTION Arizona, Arkansas, California, Idaho, Ohio. QUANTITY 140 lenses were distributed. REASON The label states the lens has a diameter of 6.5mm while the actual diameter of the lens is 6.0mm. END OF ENFORCEMENT REPORT FOR OCTOBER 11, 2000.
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