April 3, 2002 02-13
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________ PRODUCT My Country Sweet - HONEY DIJON MUSTARD 8 oz. glass jars Responsible firm on the label: Manufactured for Nancy's Specialty Foods, Schenectady, NY. Recall # F-331-2. CODE Uncoded lot produced 2/19/01 Lot C0202VDJ produced 3/2/00 Lot M0692VDJ produced 12/6/99. RECALLING FIRM/MANUFACTURER Viscusi Wholesale Grocers, Inc., Schenectady, NY, by telephone and visits beginning December 10, 2001 and by press release on December 11, 2001. FDA initiated recall is ongoing. REASON The product contained undeclared eggs. VOLUME OF PRODUCT IN COMMERCE 454 cases/12 per case. DISTRIBUTION NY, NJ, PA, CT and MA. _______________________ PRODUCT A) Awrey's brand Date Nut Bars, Recall # F-333-2; - 8 Pack, 10.75 ounce package, product number 1760, - 8 Pack, 10.75 ounce package, product number 1763 - Twin Pack, 2.5 ounce package, product number 1785 B) Awrey's brand Date Oatmeal Bars, 8 Pack, 12 ounce package, product number 1990, Recall # F-334-2; C) Awrey's brand Strawberry Bars, Twin Pack, 2.5 ounce package, product number 1785, Recall # F-335-2; D) Awrey’s brand Sliced Buttermilk Biscuits, 2 ounce, sold in cases of 5 dozen, frozen, fully baked, product number 1125-35, Recall # F-336-2; E) F-337-2 Awrey's brand Country Hy Biscuit, 2 ounce, sold in cases of 4 dozen, frozen, fully baked, product number 1140-35, Recall # F-336-2. CODE Products distributed prior to December 13, 2001 are under recall. RECALLING FIRM/MANUFACTURER Awrey Bakeries Inc., Livonia, MI, by telephone, letter and press release on December 14, 2001. Firm initiated recall is complete. REASON A-C) Undeclared nonfat milk. D-E) Undeclared eggs. VOLUME OF PRODUCT IN COMMERCE Bars and Brownies: 26,083 cases. (NOTE: Brownies are listed under Class III, Recall # F-338-2) Biscuits: 120,396 cases. DISTRIBUTION Bars: MI, NY. Biscuits: MI, OH and TN. _______________________ PRODUCT WEGMANS Old Fashioned FAMILY WHEAT Thin Sliced Bread 32 oz. plastic bag. Recall # F-339-2. CODE USE BY 11/09. RECALLING FIRM/MANUFACTURER Wegmans Food Markets, Rochester, NY, by press release, e-mail and post card on November 17, 2001. Firm initiated recall is complete. REASON The product contained undeclared walnuts. VOLUME OF PRODUCT IN COMMERCE 353 loaves DISTRIBUTION NY, PA and NJ. _______________________ PRODUCT Jars labeled: "WHOLE FOODS Crunchy Organic Peanut Butter" UPC: 0 99482 16002 (peanut butter label) The product is in 16 oz. glass jars. The responsible firm on the label is: WHOLE FOODS, Austin, TX. Recall # F-340-2. CODE Jars labeled "USE BY 10/30/02" / cases labeled "10/30/01" (The jar code is stamped on the cap) RECALLING FIRM/MANUFACTURER Once Again Nut Butter, Inc., Nunda, NY, by e-mail beginning December 17, 2001, and press release on December 19, 2001. Firm initiated recall is complete. REASON Jars labeled as Crunchy Peanut Butter actually contain Crunchy Almond Butter. VOLUME OF PRODUCT IN COMMERCE 1,201 cases/12 jars per case. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________ PRODUCT Goldensmell Preserved Ginger, Net weight 4.0 oz. Product of China. Recall # F-332-2. CODE No codes. RECALLING FIRM/MANUFACTURER Recalling Firm: Strong America Limited, Brooklyn, NY, by letters on May 21, 2001. Manufacturer: Xiamen Da Chang Hua Imp. & Exp. Co. Ltd., Xiamen, Fujian, China. State initiated recall is complete. REASON The product contained Ponceau 4R (E124, Acid Red 18), an unapproved color additive, and undeclared sulfites. The product also contained undeclared sunset yellow FCF (certifiable as FD&C Yellow #6). VOLUME OF PRODUCT IN COMMERCE 120 cases (100 - 4 oz. jars per case). DISTRIBUTION NY.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
_______________________ PRODUCT Chocolate Peanut Sensation Brownies under the Awrey’s, GFS and Sysco Classic labels. Recall # F-338-2. CODE Products distributed prior to December 13, 2001 are under recall. RECALLING FIRM/MANUFACTURER Awrey Bakeries Inc., Livonia, MI, by telephone, letter and press release on December 14, 2001. Firm initiated recall is complete. REASON Incomplete ingredient statement. VOLUME OF PRODUCT IN COMMERCE 26,083 cases of brownies and bars. (NOTE: Bars are listed under class I, Recall #F-332/335-2) DISTRIBUTION Nationwide.
_______________________ PRODUCT Oxygen USP, compressed in size C, D and E in steel and aluminum Cylinders. Recall # D-218-2. CODE Lots 020501/4, 020502/5, 020503/4 and 020504/5. RECALLING FIRM/MANUFACTURER Southern Welding Supply Co., Inc., Savannah, GA, by telephone on February 20, 2002. Firm initiated recall is ongoing. REASON Good Manufacturing Practice (GMP's) deviations including, but not limited to, failure to test product for purity and identity. VOLUME OF PRODUCT IN COMMERCE 70 cylinders. DISTRIBUTION GA.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT Necon 1/50-28 Tablets (Norethindrone 1.0 mg and Mestranol 0.05 mg. Recall # D-217-2. Cartons of six (6) tablet dispensers, twenty eight (28) tablets each. Each light blue tablet (21) contains noethindrone 1 mg and mestranol 50 mcg. Each white tablet contains inert ingredients. CODE Lot & Exp. Amnt Dist. No. Cust. (ctns) 51001X99 12/2002 6936 78 51001B00 3/2003 6501 88 51001D00 4/2003 7176 85 51002D00 4/2003 7231 58 RECALLING FIRM/MANUFACTURER Watson Pharmaceuticals, Inc., Corona, CA, by letter on February 27, 2002. Firm initiated recall is ongoing. REASON Subpotent for mestranol component (stability). VOLUME OF PRODUCT IN COMMERCE 27,844. DISTRIBUTION Nationwide and Puerto Rico.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT a) Platelets Unit, Recall # B-0939-2; b) Recovered Plasma, Recall # B-0940-2. CODE a) and b) Unit GR08104. RECALLING FIRM/MANUFACTURER Reading Hospital and Medical Center, West Reading, PA, by telephone and letter on January 8, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor taking the drug Proscar, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION PA and MD. _______________________ PRODUCT Red Blood Cells, Recall #Z-0941-1. CODE Unit 5819727. RECALLING FIRM/MANUFACTURER LifeSource Blood Services, Glenview, IL, by telephone on July 2, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who had traveled to an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IL. _______________________ PRODUCT Platelets, Pheresis, Leukoreduced, Recall # B-0942-2. CODE Unit 40P75174. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Heart of America Region, Peoria, IL, by letter dated May 18, 2000. Firm initiated recall is complete. REASON Blood product, which may have been stored at unacceptable temperatures, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IL. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0943-2. CODE Units 02FG71597, 02FG71571, 02FG71632, 02FG71573, 02FC58602, 02FC58603, 02LE03383, 02LE03387, 02LE03384, 02LE03386, 02FC58604 RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Central Plains Region, Wichita, KS, by letter and telephone on July 28, 1999. Firm initiated recall is complete. REASON Leukoreduced blood products, that were filtered two times, were distributed. VOLUME OF PRODUCT IN COMMERCE 11 units. DISTRIBUTION KS. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0944-2; b) Fresh Frozen Plasma, Recall # 0945-2. CODE a) and b) Unit C93817. RECALLING FIRM/MANUFACTURER Heartland Blood Centers, Aurora, IL, by letter dated December 26, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who was at increased risk for CJD, due to a history of taking insulin injections, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION IL. _______________________ PRODUCT Red Blood Cells, Recall # B-0947-2. CODE Units 19233-3876, 19237-0198, 19238-9590, 19240-9961. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated May 30 or July 25, 2001. Manufacturer: United Blood Services, Reno, NV. Firm initiated recall is complete. REASON Blood products, collected from a donor who was diagnosed with Nephrotic Syndrome, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION NY, TX, IL and NV. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0949-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-0950-2; c) Platelets, Recall # B-0951-2; d) Recovered Plasma, Recall # B-0952-2. CODE a) Unit 2130812; b) and c) Unit 2037458; d) Unit 2130812, 2037458. RECALLING FIRM/MANUFACTURER Sylvan N. Goldman Institute, Dba Oklahoma Blood Institute, Oklahoma City, OK, by fax on February 18, 1997. Firm initiated recall is complete. REASON Blood products, which tested negative for anti-HCV, but were collected from a donor who previously tested repeatedly reactive for anti-HCV, RIBA indeterminate, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION MO and OK. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0985-2. CODE Units 29FL59852, 29KJ07081, 29FX57038. RECALLING FIRM/MANUFACTURER American Red Cross, Mid-Atlantic Region, Norfolk, VA, by letter dated Nov. 21, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION MD. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall #B-0986-2; b) Frozen Plasma for Further Manufacture, Recall # B-0987-2. CODE a) and b) Unit 53FP35970. RECALLING FIRM/MANUFACTURER American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter dated April 4 and June 11, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of having tested positive for Hepatitis B, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MD. _______________________ PRODUCT Source Plasma, Recall # B-0988-2 CODE Units 0010641493, 0010620193, 0010613919, 0010612407, 0010609269, 0010614885, 0010604885, 0010605027, 0010605564, 0010605735, 0010606511, 0010607124, 0010607790, 0010608338, 0010610173, 0010610603, 0010615325, 0010615610, 0010616234, 0010616987, 0010617288, 0010618050, 0010618871, 0010619201, 0010619516, 0010620574, 0010621009, 0010626489, 0010638440, 0010641251, 0010641862, 0010642409, 0010642891. RECALLING FIRM/MANUFACTURER Nabi Biomedical Center, Ft. Meyers, FL, by letter or fax on February 24 or March 3, 1998. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of having tested positive for Hepatitis B, was distributed. VOLUME OF PRODUCT IN COMMERCE 33 units. DISTRIBUTION FL and NC. _______________________ PRODUCT a) Red Blood Cells Recall # B-0992-2; b) Red Blood Cells, Leukoreduced, Recall # B-0993-2; c) Fresh Frozen Plasma, Recall # B-0994-2; d) Recovered Plasma, Recall # B-0995-2. CODE a) and c) Unit 15 009-3060; b) and d) Unit 15 010-5622. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letters on March 28 and June 7, 2001. Manufacturer: Blood Systems, Inc., Lubbock, TX. Firm initiated recall is complete. REASON Blood products, collected from a previously deferred donor, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION TX and NY. _______________________ PRODUCT Fresh Frozen Plasma, Recall # B-0997-2. CODE Units 0678760, 0802089, 0820116, 0678757, 0804122, 0820128, 0802087 RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, Cincinnati, OH, by telephone on November 7, 2001. Firm initiated recall is complete. REASON Seven units of Platelets, that had been pooled, were implicated in a transfusion reaction in which the pooled unit was found to be contaminated with Staphylococcus, coagulase negative bacteria. Corresponding blood products were distributed. VOLUME OF PRODUCT IN COMMERCE 7 units. DISTRIBUTION OH. _______________________ PRODUCT Red Blood Cells, Recall # B-0998-2. CODE Unit FX13459. RECALLING FIRM/MANUFACTURER Gateway Community Blood Program, St. Louis, MO, by letter and telephone on February 4, 2000. Firm initiated recall is complete. REASON Blood product, which had an elevated ALT test result, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MO. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1004-2; b) Plasma, Cryoreduced, Recall # B-1005-2; c) Cryoprecipitate AHF, Pooled, Recall # B-1006-2; CODE a) and b) Unit, 0629832; c) Unit 0524432. RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, San Francisco, CA, by letters dated September 6 or October 2, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor who was at increased risk for new variant Creutzfeld-Jakob Disease (nvCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-1010-2. CODE Unit G00260. RECALLING FIRM/MANUFACTURER Tacoma-Pierce County Blood Bank, dba Cascade Regional Blood Services, Tacoma, WA, by telephone on April 19, 2001. Firm initiated recall is ongoing. REASON Blood product, collected from a donor whose hematocrit/hemoglobin had not been documented, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION RI. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1011-2; b) Platelets, Recall # B-1012-2; c) Cryoprecipitate, Recall # B-1013-2; d) Fresh Frozen Plasma, Recall # B-1014-2; e) Recovered Plasma, Recall # B-1015-2. CODE a), c) and e) Unit 06GT08456; b) and d) Unit 06GP58249. RECALLING FIRM/MANUFACTURER American National Red Cross, Southern California Region, Los Angeles, CA, by letter dated January 14, 2000. Firm initiated recall is complete. REASON Blood products, which tested negative for anti-HCV, but were collected from a donor who previously tested positive for anti-HCV, was distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION CA. _______________________ PRODUCT Source Plasma, Recall # B-1016-2. CODE Unit 31671668. RECALLING FIRM/MANUFACTURER Nabi BioMedical Center, Corpus Christi, TX, by fax on June 9, 2000. Firm initiated recall is complete. REASON Blood product, collected from a donor who had not completed the CJD/nvCJD increased risk questions, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Platelets, Leukoreduced, Recall # B-1017-2. CODE Unit FK48769. RECALLING FIRM/MANUFACTURER Healthcare Provider Services Inc., dba Rhode Island Blood Center,Providence, RI, by letter dated January 4, 2002. Firm initiated recall is complete. REASON Blood product, collected from a donor whose hematocrit/hemoglobin had not been documented, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION RI. _______________________ PRODUCT a) Red Blood Cells for Further Manufacturing, Recall # B 1019-2; b) Human Serum, Recall # B-1020-2. CODE a) Units VF-05986, VF-06225, VF-06612, and VF-06778. b) Unit VF-05986. RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA, by letters dated March 28, 2000. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who was listed on the California Donor Deferral Registry for testing positive for an infectious disease, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION NJ and NE. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1021-2; b) Platelets, Recall # B-1022-2; c) Fresh Frozen Plasma, Recall # B-1023-2. CODE a), b) and c) Unit 21K25386. RECALLING FIRM/MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, OR, by letters dated August 31, 2001. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who admitted to engaging in multiple high risk behaviors, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION OR. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1024-2; b) Cryoprecipitated AHF, Recall # B-1025-2; c) Recovered Plasma, Recall # B-1026-2. CODE a), b) and c) Unit 21KH41204. RECALLING FIRM/MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, OR, by telephone on July 11 or by letter dated July 25 or by fax on July 12, 2001. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who previously tested positive for the antibody to the hepatitis C virus encoded antigen (anti- HCV), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION OR, CA and Switzerland. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1027-2; b) Plasma, Recall # B-1028. CODE a) Units 21FL51726, 21FL49281, and 21FL46723; b) Unit 21FL46723. RECALLING FIRM/MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, OR, by telephone on July 30 and/or by letters dated August 13 or by fax August 1, 2001. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who admitted to engaging in multiple high risk behaviors, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION OR, WA and Switzerland.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0989-2. CODE Unit 15-388-3780. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated September 12, 2001. Manufacturer: United Blood Services, Lubbock, TX. Firm initiated recall is complete. REASON Blood product, that failed the red cell recovery ratio, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION TX. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0990-2. CODE Unit 15-387-9343. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on May 22, 2001. Manufacturer: United Blood Services, Lubbock, TX. Firm initiated recall is complete. REASON Blood product, that failed the red cell recovery ratio, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION TX. _______________________ PRODUCT Red Blood Cells, Recall # B-0991-2. CODE Unit 7310908. RECALLING FIRM/MANUFACTURER Department of the Airforce, Lackland AFB, TX, by fax on June 26 and 28, 2000. Firm initiated recall is complete. REASON Blood product, which tested initially reactive for syphilis, was distributed. Confirmatory testing determined that the unit was non- reactive for syphilis. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION TX. _______________________ PRODUCT Red Blood Cells, Recall # B-0996-2. CODE Unit 2124613. RECALLING FIRM/MANUFACTURER LifeShare, Inc., Elyria, OH, by letter dated December 6, 2001. Firm initiated recall is complete REASON Blood product, labeled with an extended expiration date, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OH. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0999-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-1000-2; c) Platelets, Pheresis, Leukocytes Reduced, Recall # B-1001-2; d) Cryoprecipitated AHF, Pooled, Recall # B-1002-2; e) Recovered Plasma, Recall # B-1003-2. CODE a) Units R11670, R11672, R11673, R11675, R11676, R11679, R11681, R11682; b) Units R11680, KZ59382, KZ59383, KZ59384; c) Units R11671-1, R11671-2, R11674-1, R11677-1, R11677-2, R11678-1; d) Units KZ59382; pool number P14117; e) Units KZ59382, KZ59383, KZ59384, FJ70472. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on April 26 and by letters dated May 4, 2001. Firm initiated recall is complete. REASON Blood products, not tested according to the manufacturer’s directions for HTLV-I/II, were distributed. VOLUME OF PRODUCT IN COMMERCE 23 units. DISTRIBUTION WI. _______________________ PRODUCT Source Plasma, Recall # B-1018-2. CODE Unit CP-15665. RECALLING FIRM/MANUFACTURER Pyramid Biological Corp., Van Nuys, CA, by letter dated March 2, 2001. Firm initiated recall is complete. REASON Blood product, which was collected from a donor whose health history screening was not adequately performed in that there was no documentation on the donor history form that a satisfactory arm inspection was conducted, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Austria. _______________________ PRODUCT Recovered Plasma, Recall # B-1029-2. CODE Units 21FL51726 and 21FL49281. RECALLING FIRM/MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, OR, by telephone on July 30 and/or by letters dated August 13 or by fax on August 1, 2001. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who admitted to engaging in multiple high risk behaviors, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION OR, WA and Switzerland.
_______________________ PRODUCT FlexiLab Laboratory Information System, versions 5.23 and 5.3 with Specimen Management Routing and Tracking (SMART). Recall # Z-0656-2. CODE FlexiLab version 5.23 and version 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by mailing June 21, 2001. Firm initiated recall is ongoing. REASON Container ID labels print incorrectly, names of patients mix. VOLUME OF PRODUCT IN COMMERCE 164. DISTRIBUTION Nationwide and the United Kingdom, Denmark, Canada, Ireland and Bermuda. _______________________ PRODUCT ID-MTS (Micro Typing System) IMPACT Pipettor. Recall # Z-0667-2. CODE ID-MTS Impact Pipettor Catalog Number: 1022-05 Serial Numbers: 182189 182190 182191 182192 182193 182194 182195 182196 182197 182198 182199 182200 182201 182202 182203 182204 182205 182206 182207 182208 182209 182210 182211 182212 182213 182214 182215 182216 182218 182219 182220 182221 182222 182223 182224 182225 182226 182269 182270 182271 182272 182274 182278 182227 182228 182229 182230 182231 182232 182233 182234 182235 182236 182237 182238 182239 182240 182241 182245 182246 182248 182260 182262 182263 182264 182266 182267 182268 182289 182291 182294 182302 182305 182306 182307 182309 182310 182311 182312 182316 182317 182318 182371 182372 182375 182376 182381 182242 182243 182244 182390 182392 182421 182427 182429 182432 182440 182441 182443 182446 182448 182449 182450 182460 182461 182474 182475 182482 182487 182492 182495 182498 182509 182510 182511 182512 182513. RECALLING FIRM/MANUFACTURER Matrix Technologies Corp., Hudson, NH, by letter dated December 20, 2001. Firm initiated recall is ongoing. REASON Motor may fail resulting in inaccurate volume filling and causing a false negative test result. VOLUME OF PRODUCT IN COMMERCE 147 units. DISTRIBUTION FL. _______________________ PRODUCT Haemophilus Test Medium Agar, catalog #221954, packaged as plated media, 8 plates per plastic package. Recall # Z-0668-2. CODE Lot 1275334, exp 1/22/02. RECALLING FIRM/MANUFACTURER Recalling Firm: Becton Dickinson, Sparks, MD, by letter, fax or e-mail on January 15, 2002. Manufacturer: Becton Dickinson Microbiology Systems, Cockeysville, MD. Firm initiated recall is ongoing. REASON Micobiological test media may exhibit insufficient growth of bacteria. VOLUME OF PRODUCT IN COMMERCE 2009 packages. DISTRIBUTION Nationwide and Belgium, Taiwan and Canada. _______________________ PRODUCT Beckman Coulter Synchron LX20 Clinical System. This is a machine used to perform clinical chemistry tests on patient specimens. Recall # Z-0670-2. CODE Part number 466000. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc. Brea, CA, by letter dated February. 8, 2002. Firm initiated recall is a 24- hour alert. REASON Synchron LX20 Low cc side chemistries. VOLUME OF PRODUCT IN COMMERCE 793. DISTRIBUTION Nationwide and Canada. _______________________ PRODUCT Smoke Evacuator Hoses, sterile and non-sterile, single use only. Recall # Z-0671-2/Z-0676-2. Each hose unit is packaged in a Tyvek bag under the DM Medical label, with a disposable aspirator adapter. The following items are recalled: Catalog # Description HA-3 1 1/4" X 5' Sterile tubing, 10/box. Recall # Z-0671-2; HA-4 1 1/4" X 5' Non-Sterile tubing, 10/box. Recall # Z-0672-2; HA-8 1 1/4" X 10' Sterile tubing, 5/box. Recall # Z-0673-2; HA-9 7/8" X 10' Sterile tubing, 10/box. Recall # Z-0674-2; HA-9N 7/8" X 10' Non-sterile tubing, 10/box. Recall # Z-0675-2; 0007-1810 7/8" X 10' Sterile tubing, 10/box. Recall # Z-0676-2. CODE All lot numbers. RECALLING FIRM/MANUFACTURER DM Medical, Inc. Cincinnati, OH, by recall notices on February 28, 2002. FDA initiated recall is ongoing. REASON QSR deviations including: no validated sterilization process, and lack of 510 (k). VOLUME OF PRODUCT IN COMMERCE 440 boxes (3,240 hoses). DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________ PRODUCT DynaGraft Gel and Putty, a mixture of human demineralized allograft bone powder mixed with a reverse-phase medium and formulated into a gel or putty consistency. Packed into 10 cc plastic syringes, 10 cc Nagalene vials or 1 cc Nagalene vials. Recall # Z—0596-2. CODE DynaGraft Gel from Lot LN1990721001 to LN1990721041; DynaGraft Putty, 10 cc vial from LN1990489001 to LN1990489025; DynaGraft Putty, 1 cc vial from LN1990489026 to LN1990489028 and LN1990489030. RECALLING FIRM/MANUFACTURER GenSci OrthoBiologics, Inc., Irvine, CA, by notice dated November 12, 2001. Firm initiated recall is complete. REASON Donor Screening Problems. VOLUME OF PRODUCT IN COMMERCE 68 units. DISTRIBUTION Nationwide and Canada. _______________________ PRODUCT PASV (Pressure Activated Safety Valve) PICC Peripherally Inserted Central Catheters. Recall # Z-0657-2/0658-2. CODE PASV PICC Peripherally Inserted Central Cathters Catalog Number Product Description PIC401CK PASV PICC 4F/SL/S/CK PIC501CK PASV PICC 5F/SL/S/CK PIC601CK PASV PICC 6F/SL/S/CK PIC402CK PASV PICC 4F/DL/S/CK PIC502CK PASV PICC 5F/DL/S/CK PIC602CK PASV PICC 6F/DL/S/CK PIC301CKP PASV PICC 3F/SL/P/CK PIC401CKP PASV PICC 4F/SL/P/CK PIC501CKP PASV PICC 5F/SL/P/CK PIC502CKP PASV PICC 5F/DL/P/CK Devices shipped between 6/2001-9/19/2001. RECALLING FIRM/MANUFACTURER Recalling Firm: Boston Scientific Corp./Medi Tech Division, Natick, MA, by letters on December 6, 2001. Manufacturer: Medi Tech a division of Boston Scientific, Salt Lake City, UT. Firm initiated recall is ongoing. REASON Instructions for use and/or patient information guides may be omitted. VOLUME OF PRODUCT IN COMMERCE 64 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Roche CSA Cobas Integra 700 Cyclosporine reagent. Recall # Z-0669-2. CODE Catalog # 2064391, Art # 0753564. All lots. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by notice dated February 22, 2002. Manufacturer: Roche Diagnostics, Mannheim, Germany. Firm initiated recall is ongoing. REASON Revised calibration frequency due to reduced standard curve stability. VOLUME OF PRODUCT IN COMMERCE 221. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
_______________________ PRODUCT IBA Anti-Diarrhea Bolus, Adsorbent Anti-Diarrheal Bolus for Cattle, packaged in 50-bolus jars, each bolus contains activated attapulgite, carob flour, pectin and magnesium trisillicate in a sugar and starch base, for oral administration, for use as an aid in relief of simple non-infectious diarrhea in horses and cattle. The responsible firm on the label shows the product is Manufactured for IBA Inc., Animal Health Division, Millbury, MA. Recall # V-030-2. CODE Lot 010504, Exp. 08/03 Lot 010505, Exp. 08/03. RECALLING FIRM/MANUFACTURER Veterinary Laboratories, Inc. Lenexa, KS, by telephone on August 28, 2001. Firm initiated recall is ongoing. REASON Mislabeled as anti-diarrhea bolus. VOLUME OF PRODUCT IN COMMERCE 144/50-bolus jars. DISTRIBUTION MA.END OF ENFORCEMENT REPORT FOR APRIL 3, 2002 ####
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