April 10, 2002 02-14
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________ PRODUCT a) Sonoma brand Teleme Spreadable Cheeses (packaged in 8/7.5oz rectangle plastic containers and 8/9oz boxes). Recall # F-341-2; b) Sonoma Cheddar Wheels and Wedges. Recall # F-342-2; c) Sonoma Jack Wheels and Wedges. Recall # F-343-2. CODE All lots. RECALLING FIRM/MANUFACTURER Sonoma Foods, Inc., Sonoma, CA, by press release on May 1, 18 and 29, 2001. FDA initiated recall is complete. REASON The products are contaminated with Listeria monocytogenes. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION Nationwide. _______________________ PRODUCT a) Acti-Gest Tablets, 150 mg/tab. Recall # F-345-2; b) Super Enzyme Capsules, 50 mg/cap. Recall #F-346-2; c) Super Enzyme Tablets, 50 mg/tab. Recall # F-347-2. CODE a) Lot 0101288; b) Lot 0101284; c) Lot 0101216. RECALLING FIRM/MANUFACTURER Horizon Laboratories, Inc., Chatsworth, CA, by letter on May 14, 2001. Firm initiated recall is complete. REASON Contaminated with Salmonella spp. VOLUME OF PRODUCT IN COMMERCE Firm distributed all products manufactured. DISTRIBUTION CA. ______________________ PRODUCT a) Deli Fresh Delux Roast Beef Sub - 8 oz in plastic wrap. Recall # F-349-2; b) Deli Fresh Delux Ham Sub - 8 oz in plastic wrap. Recall # F-350-2; c) Deli Fresh Delux Turkey Sub - 8 oz in plastic wrap. Recall # F-351-2; d) Deli Fresh Ham and Cheddar Croissant Sandwich - 6 oz in plastic wrap. Recall # F-352-2; e) Deli Fresh Turkey and Cheddar Croissant Sandwich - 5 oz in plastic wrap. Recall # F-353-2; f) Deli Fresh Tuna Salad Sandwich - 5 oz in plastic wrap. Recall #F-354-2; g) Deli Fresh Chicken Salad Sandwich - 5 oz in plastic wrap. Recall # F-355-2; h) Deli Fresh Roast Beef and Cheddar Croissant Sandwich - 5 oz in plastic wrap. Recall # F-356-2; i) Deli Fresh Tuna Salad Croissant Sandwich - 5 oz in plastic Wrap. Recall # F-357-2; j) Deli Fresh Chicken Salad Croissant Sandwich - 5 oz in plastic wrap. Recall # F-358-2; k) Deli Fresh Corned Beef and Swiss Croissant Sandwich - 5 oz in plastic wrap. Recall # F-359-2. CODE Jun 9 01. RECALLING FIRM/MANUFACTURER K & S Wholesale Meats Sun Prairie, WI, by pulling product on June 5, 2001. Firm initiated recall is complete. REASON Undeclared eggs in subs and sandwiches. VOLUME OF PRODUCT IN COMMERCE 100 + sandwiches. DISTRIBUTION WI. _______________________ PRODUCT Yellow Sheet cake. Recall # F-360-2. The sheet cakes are sold in cartons (4 cakes per carton) labeled "Yellow Cake - Full Sheet Publix 85170". The individual sheet cakes are unlabeled. CODE Lot #1258 Use By: 9/15/02. RECALLING FIRM/MANUFACTURER Recalling Firm: Rich Products Corp., Buffalo, NY, by e-mail on October 5, 2001 and press release on October 11, 2001. Manufacturer: J.W. Allen Frozen Cake, Div. of Rich Products, Morristown, TN. Firm initiated recall is complete. REASON The product may contain undeclared walnuts. VOLUME OF PRODUCT IN COMMERCE 960 cases. DISTRIBUTION FL, GA and SC. _______________________ PRODUCT NARSAI’S brand Butter Caramel Decadence (Sauce). Recall # F-361-2. CODE MNBCD1039B MNBCD1051B MNBCD1093A MNBCD1093B MNBCD1240A MNBCD1271A MNBCD1192B. RECALLING FIRM/MANUFACTURER Recalling Firm: Narsai’s Specialty Foods. Inc., Pinole, CA, by telephone and letters on October 3, 2001. Manufacturer: Mad Will’s Food Company Auburn, CA. Firm initiated recall is complete. REASON Product may contain undeclared nuts. VOLUME OF PRODUCT IN COMMERCE 248 cases. DISTRIBUTION CA, MO, KN, NM, OH and WA. _______________________ PRODUCT Valley Lahvosh brand Original American Sesame Seed Bread in 15¾ Oz packages: a) Cracker Bread. Recall # F-362-2; b) Cracker Bread, Cracked Wheat. Recall # F-363-2. CODE Cracker Bread USE BY Cracked Wheat USE BY 03-28-03 3/24/03 03-24-03 2/27/03 02-27-03 12/6/02 12-28-02 10/27/02 12-19-02 8/27/02 12-06-02 6/13/02 11-14-02 5/7/02 10-27-02 1/21/02 09-06-02 08-21-02 08-07-02 07-12-02 06-21-02 06-13-02 05-28-02 04-06-02 04-05-02 02-11-02 01-26-02 01-21-02 12-01-01 11-22-01. RECALLING FIRM/MANUFACTURER Valley Lahvosh Baking Co., Fresno, CA, by telephone and letters on or about October 26, 2001. FDA initiated recall is complete. REASON Products contain undeclared milk ingredients. VOLUME OF PRODUCT IN COMMERCE 18,286 cases. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________ PRODUCT Sulfur Sublimed Powder, USP, 4 oz plastic bottle, Humco Trademark. Recall # D-219-2. Sodium Bicarbonate Oral Powder, USP, 4 oz bottle, Humco Trademark. Recall # D-220-2. CODE Sulfur Sublimed Sodium Bicarbonate Powder USP Oral Powder USP Lot No 237059 272629 Humco Catalog No. 279994001 268594001 AmeriSource Cat No. Unknown 1973832 Borschow Cat. No. not in catalog H7567 NDC 0395-2799-94 0395-2685-94 Exp. Date 10/05 6/05. RECALLING FIRM/MANUFACTURER Borschow Hospital & Medical Supplies, Inc., Hato Rey, Puerto Rico, by letter on December 3, 2000. FDA initiated recall is ongoing. REASON Mislabeling of Sulfur Sublimed as Sodium Bicarbonate (by product price label supplied by Borschow Hospital & Medical Supplies, Inc). VOLUME OF PRODUCT IN COMMERCE 152 units. DISTRIBUTION Puerto Rico. _______________________ PRODUCT Pentothal, Ready to Mix Syringe, Thiopental Sodium for Injection, 500 mg. 2.5% (25 mg/mL) vial, 20 ml Abboject Syringe, and Sterile Water in a 20 mL Fliptop Vial and Injector, 25 kits per case. Recall # D- 223-2. CODE Lot No. 80-076-DK. RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Laboratories, Abbott Park, IL, by letter dated February 15, 2002. Manufacturer: Abbott Laboratories, Rocky Mount, NC. Firm initiated recall is ongoing. REASON Component Mix-up. VOLUME OF PRODUCT IN COMMERCE 18,000 units. DISTRIBUTION Nationwide. _______________________ PRODUCT a) Chloral Hydrate Syrup USP, 500 mg/5mL, 5 mL unit dose cups, 10 cups per tray, 10 trays per case. Recall # D-225-2. b) Phenobarbital Elixir, 20 mg/5 mL, 5 mL unit dose cups, 10 cups per tray, 10 trays per case. Recall # D-226-2. CODE a) Lots 1E46, 1H52, 1K17 NDC-0121-0532-05 b) Lot 1K49 NDC-0121-0531-05. RECALLING FIRM/MANUFACTURER Pharmaceutical Associates, Inc., Greenville, SC, by letter on March 4, 2002. Firm initiated recall is ongoing. REASON Overfill of drug cups which could lead to twice the labeled amount of active ingredient being dispensed. VOLUME OF PRODUCT IN COMMERCE a) 284,860/5 mL cups; b) 4,207/5 mL cups. DISTRIBUTION Nationwide. _______________________ PRODUCT Meclizine Tablets 25 mg, 30 tablets per bottle, labeled as Packaged by QCP. Rx Only. Recall # D-227-2. CODE Lot 00037, Exp. 6/30/03, NDC 49999-029-30. RECALLING FIRM/MANUFACTURER Recalling Firm: Quality Care Products, L.L.C. Temperance, MI, by telephone and letter on March 18, 2002. Manufacturer: Par Pharmaceutical, Spring Valley, NY. Firm initiated recall is ongoing. REASON Mispackaging at repacking firm; bottles labeled as 25 mg actually contain 12.5 mg tablets. VOLUME OF PRODUCT IN COMMERCE 33 bott les. DISTRIBUTION OK, TN, and WI.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT Epinephrine Mist Kit, Epinephrine Inhalation Aerosol, USP, 5.5 mg/mL 1/2 Fl. Oz., Kit contains nebulizer/actuator packaged with vial. Recall # D-221-2. Epinephrine Mist-Epinephrine Inhalation Aerosol USP Refill, 5.5 mg/mL, packaged in 0.5 ounce plastic coated glass vials, 1 vial per box, 24 boxes/carton. Recall # D-222-2. CODE Kit with Inhaler (1/2 oz) Lot Number Expiration Date RB0166 28-Feb-02 RB0170 28-Feb-02 RB0171 31-Mar-02 RB1200 31-Jan-03 RB1201 31-Jan-03 RB1204 28-Feb-03 RB1205 28-Feb-03 RB1207 28-Feb-03 RB1208 28-Feb-03 RC0176 30-Apr-02 RC1209 28-Feb-03 RC1213 31-Mar-03 RD0178 30-APR-02 RD0180 31-Mar-02 RD0182 30-Mar-02 RD0183 30-Mar-02 RF1414 30-Mar-03 RH0543 30-Jun-02 RH0544 31-Jul-02 RH0547 31-Jul-02 RH0548 31-Jul-02 RJ1669 30-Jun-03 RJ1671 30-Jun-03 RJ1672 30-Jun-03 RK0551 31-Aug-02 RK0552 31-Aug-02 RK0553 31-Aug-02 RK0689 30-Sep-02 RK1676 31-Jul-03 RK1677 31-Jul-03 RK1680 31-Aug-03 RL0690 30-Sep-02 RL0691 30-Sep-02 RN0698 31-Oct-02 RN0699 31-Oct-02 RN0700 31-Oct-02 RP0834 31-Oct-02 RP0835 31-Oct-02 RS0840 31-Jan-03 RS0841 31-Jan-03 Refill (1/2 oz) Lot Number Expiration Date RB0167 28-Feb-02 RB0168 28-Feb-02 RB0169 28-Feb-02 RB1202 28-Feb-03 RB1203 28-Feb-03 RB1206 28-Feb-03 RC0172 31-Mar-02 RC0173 03-Jan-00 RC0177 28-Feb-02 RC1210 31-Mar-03 RC1211 31-Mar-03 RC1212 31-Mar-03 RC1214 31-Mar-03 RD0179 31-Mar-02 RD0181 30-Mar-02 RD0410 31-Mar-03 RD1405 30-APR-03 RD1406 31-May-03 RD1407 31-May-03 RD1408 31-May-03 RD1409 31-May-03 RF1410 31-Mar-03 RF1412 31-Mar-03 RF1413 31-Mar-03 RH0542 30-Mar-02 RH0545 31-Jul-02 RH0546 31-Jul-02 RH0549 31-Aug-02 RH0550 31-Aug-02 RJ1670 30-Jun-03 RJ1674 30-Jun-03 RK0554 31-Aug-02 RK0555 31-Aug-02 RK0688 31-Aug-02 RK1675 31-Jul-03 RK1678 31-Jul-03 RK1679 31-Aug-03 RL0692 30-Sep-02 RL0693 30-Sep-02 RL0694 30-Sep-02 RL0695 31-Oct-02 RL1977 31-Aug-03 RN0696 31-Oct-02 RN0701 31-Oct-02 RP0833 31-Oct-02 RP0836 30-Nov-03 RP0837 30-Nov-03 RP0838 31-Jan-03 RS0839 31-Jan-03 RS0841 31-Jan-03 RS0841 31-Jan-03 RS0842 31-Jan-03 RS0843 31-Jan-03. RECALLING FIRM/MANUFACTURER Recalling Firm: Alpharma USPD, Baltimore, MD, by letter on February 26, 2002. Manufacturer: Armstrong Laboratories, Inc., West Roxbury, MA. Firm initiated recall is ongoing. REASON Failure to test Purified Water ingredient for all microbial specifications. VOLUME OF PRODUCT IN COMMERCE 4,333,356 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Aspirin and Codeine Phosphate Tablets, 325mg/30mg, 100 tablet bottles, Rx only. Recall # D-224-2. The product is sold under the Vintage, Qualitest, and URL labels. CODE Lot Numbers 129089A, 129089B, 129089C, 129089D, 108080A, 108080B, 108080C, 108080E, 108080F, 108080G, 011120A, 011120B, 011120C, 011120E. RECALLING FIRM/MANUFACTURER Recalling Firm: Vintage Pharmaceuticals, Huntsville, AL, by letter on November 12, 2001. Manufacturer: Vintage Pharmaceuticals, Charlotte, NC. Firm initiated recall is complete. REASON Codeine Phosphate component may not maintain potency throughout labeled expiry date. VOLUME OF PRODUCT IN COMMERCE 58,368 units. DISTRIBUTION AL. _______________________ PRODUCT Clartin-D 12 Hour Tablets, (5 mg Loratadine/120 mg pseudoephedrine sulfate, USP), Extended release tablets, Rx only, 100 tablet bottles, 100 unit dose tablets, and 30 tablet blister packs. Recall # D-228-2. CODE All lots with the prefix number of "0" or "1" (representing the years 2000 and 2001 respectively). Also lots 9-JRP- 313, 9-JRP-338, 9-JRP-2040, 9-JRP-2041 and 9-JRP-2042. Batch Exp. Date Batch Exp. Date Batch Exp. Date 0-JRP-134 04/2003 0-JRP-256 10/2003 1-JRP-2045 05/2004 0-JRP-153 04/2003 1-JRP-10 12/2003 1-JRP-2047 04/2004 0-JRP-2000 07/2002 1-JRP-113 02/2004 1-JRP-2049 05/2004 0-JRP-2001 10/2002 1-JRP-2000 06/2003 1-JRP-2052 03/2004 0-JRP-2003 08/2002 1-JRP-2004 06/2003 1-JRP-2053 03/2004 0-JRP-2005 10/2002 1-JRP-2005 10/2003 1-JRP-2055 05/2004 0-JRP-2006 01/2003 1-JRP-2007 08/2003 1-JRP-2057 03/2004 0-JRP-2008 12/2002 1-JRP-2009 10/2003 1-JRP-2058 05/2004 0-JRP-2009 01/2003 1-JRP-2011 10/2003 1-JRP-2060 03/2004 0-JRP-2010 02/2003 1-JRP-2012 05/2003 1-JRP-2061 05/2004 0-JRP-2011 02/2003 1-JRP-2013 10/2003 1-JRP-2062 05/2004 0-JRP-2013 02/2003 1-JRP-2014 12/2003 1-JRP-2063 05/2004 0-JRP-2016 02/2003 1-JRP-2015 10/2003 1-JRP-2064 05/2004 0-JRP-2017 02/2003 1-JRP-2016 01/2003 1-JRP-2065 05/2004 0-JRP-2022 03/2003 1-JRP-2019 12/2003 1-JRP-2066 05/2004 0-JRP-2023 02/2003 1-JRP-2020 01/2004 1-JRP-2067 05/2004 0-JRP-2025 03/2003 1-JRP-2021 08/2003 1-JRP-2068 05/2004 0-JRP-2027 04/2003 1-JRP-2022 01/2004 1-JRP-292 01/2003 0-JRP-2028 04/2003 1-JRP-2023 01/2004 1-JRP-324 01/2003 0-JRP-2029 03/2003 1-JRP-2024 01/2004 1-JRP-46 01/2004 0-JRP-2031 04/2003 1-JRP-2025 01/2004 1-JRP-52 01/2004 0-JRP-2033 04/2003 1-JRP-2026 01/2004 9-JRP-2040 09/2002 0-JRP-2034 04/2003 1-JRP-2027 01/2004 9-JRP-2041 10/2002 0-JRP-2036 05/2005 1-JRP-2028 08/2003 9-JRP-2042 10/2002 0-JRP-2039 02/2003 1-JRP-2029 02/2004 9-JRP-313 11/2002 0-JRP-2047 03/2003 1-JRP-203 09/2002 9-JRP-338 11/2002 0-JRP-2048 03/2003 1-JRP-2030 01/2004 0-JRP-2049 05/2003 1-JRP-2031 01/2004 0-JRP-2050 05/2003 1-JRP-2032 02/2004 0-JRP-2051 05/2003 1-JRP-2033 02/2004 0-JRP-2052 05/2003 1-JRP-2035 02/2004 0-JRP-2053 06/2003 1-JRP-2036 03/2004 0-JRP-2054 07/2003 1-JRP-2037 03/2004 0-JRP-2055 07/2003 1-JRP-2040 03/2004 0-JRP-2056 05/2003 1-JRP-2044 04/2004. RECALLING FIRM/MANUFACTURER Schering Corp., Kenilworth, NJ, by letter on February 19, 2002. Firm initiated recall is ongoing. REASON Dissolution failure; pseudoephedrine sulfate component (5th hour/18 month stability). VOLUME OF PRODUCT IN COMMERCE 7,875,653 units. DISTRIBUTION TX, PA, CA, DE and VA. _______________________ PRODUCT Claritin-D 12 Hour Extended Release Tablets, (5 mg loratadine/120 mg pseudoephedrine sulfate, USP); Rx Only, Packaged in a) 20 tablet bottle (Product No. 4094-0); b) 14 tablet bottle (Product No. 4094-1); c) 60 tablet bottle (Product No. 4094-2); d) 10 tablet bottle (Product No. 4094-3). Recall # D-229-2. CODE a) 0042080, 0055010, 0101117, 0146013, 0160042, 0174010, 0195010, 0244057, 0269160, 0291101, 0318124, 0334073, 0349135, 0363122, 1025185, 1046228, 1067144, 1086185, 1102132, 1122197, 1142124, 1157100, 1193162, 1220148, 1234121, 1254105, 1262128, 1281162, 1317148, 1325191, 1330163, 1354100, 2015153, 2023112; b) 0039104, 0063047, 0117108, 0154036, 0189024, 0208100, 0264132, 0290115, 0320132, 0332205, 0335205, 0341185, 1360424, 1362043, 2011112, 2018088 c) 0084051, 0098022, 0111068, 0157159, 0166112, 0231024, 0249120, 0259030, 0278118, 0307047, 0343028, 1003155, 1019179, 1032136, 1068023, 1078146, 1099136, 1123198, 1129153, 1141136, 1151198, 1170147, 1229041, 1247163, 1269187, 1276189, 1290107, 1306025, 1338183, 1348039, 2009151, 2042179 d) 0049098, 0053185, 0234125, 0238040, 0341212, 0354178, 1109179, 1115217, 1117053, 1124051, 1124120, 1129103, 1131049. RECALLING FIRM/MANUFACTURER Allscripts Healthcare Solutions, Libertyville, IL, by letters dated February 28, 2002. Firm initiated recall is ongoing. REASON Dissolution failure (at manufacturer, Schering Corp); pseudoephedrine sulfate component (5th hour/18 month stability). VOLUME OF PRODUCT IN COMMERCE 84,392 tablets. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0600-2. CODE Unit numbers 04KL49450 and 04KL43072. RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA, by letter dated October 23, 2001. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MA and NH. _______________________ PRODUCT Platelets, Recall # B-0948-2. CODE Unit number V42197. RECALLING FIRM/MANUFACTURER Tacoma-Pierce County Blood Bank, Cascade Regional Blood Services, Tacoma, WA, by telephone and letter on August 22, 2001. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WA. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-0954-2; b) Recovered Plasma, Recall # B-0955-2. CODE a) and b) Unit number 04FK21925. RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA, by telephone on September 6 and by letters dated September 7 and 19, 2001. Firm initiated recall is complete. REASON Blood products that were collected in a manner that may have compromised the sterility of the products were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MA and CA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0956-2. CODE Unit number 04J27447. RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA, by letter dated December 11, 2001. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0957-2. CODE Unit number 04FJ35112. RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA, by letter dated October 4, 2001. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NY. _______________________ PRODUCT a) Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0958-2; b) Platelets Pheresis, Leukocytes Reduced, Recall # B-0959-2. CODE a) Unit number 10624-0282; b) Unit number 10705-9517. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ, by letter dated May 24, 2001. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION AZ. _______________________ PRODUCT a) Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0960-2. b) Platelets Pheresis, Leukocytes Reduced, Recall # B-0961-2. CODE a) Unit number 10719-9177; b) Unit numbers 10718-3881 and 10721-3150. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ, by letter dated January 2, 2002. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION AZ. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0962-2. CODE Unit number 10713-4357. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ, by letter dated December 12, 2001. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AZ. _______________________ PRODUCT Capture-P? Test System for the detection of IgG antibodies to platelets, Recall # B-0963-2. CODE Lot number 24015. RECALLING FIRM/MANUFACTURER Immucor, Inc., Norcross, GA, by letter on June 8, 2001. Firm initiated recall is complete. REASON Test kit, labeled with the incorrect expiration date, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 lot. DISTRIBUTION Italy, England, Portugal and Germany. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0964; b) Platelets, Recall # B-0965-2; c) Fresh Frozen Plasma, Recall # B-0966-2. CODE a), b) and c) Unit number 33LJ95792. RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut Region, Farmington, CT, by letter dated December 17, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from a donor that subsequently admitted to multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION CT. _______________________ PRODUCT Fresh Frozen Plasma, Recall # B-0970-2. CODE Unit number 10721-4912. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ, by telephone on December 7, 2001. Firm initiated recall is complete. REASON Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AZ. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0971-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-0972-2. CODE a) Unit number 15008-6865; b) Unit unit numbers 15005-6388, 15012-0938, and 15006-5474. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Lubbock, TX, by letter dated October 3, 2001. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to a history of ulcerative colitis and medication with the drug Asacol, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION TX and CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0974-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-0975-2. CODE a) Unit number 15010-1762 (distributed as two split units); b) Unit number 15386-3499 (distributed as two split units). RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Lubbock, TX, by letter dated June 1, 2001. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION TX. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-0979-2; b) Recovered Plasma, Recall # B-0980-2. CODE a) and b) Unit number 15010-5538. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Lubbock, TX, by letter dated October 31 and December 15, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for the antibodies to human immunodeficiency virus (anti-HIV), but were collected from an ineligible donor due to a history of symptoms associated with HIV infection, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION TX and NY. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0981-2. CODE Unit numbers 15388-7066 and 15386-8153 (distributed as 2 split units). RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Lubbock, TX, by letter dated October 25, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for Cytomegalovirus (CMV), but were collected from a donor who previously tested CMV positive, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION TX. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced Irradiated, Recall # B-1008-2; CODE Unit number 4211180C. RECALLING FIRM/MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, AK, by letters July 19 and October 24, 2001. Firm initiated recall is complete. REASON Platelets with a decreased platelet count were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AK. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced Irradiated, Recall # B-1009-2. CODE Unit number 4211823A. RECALLING FIRM/MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, AK, by letter on August 7, 2001. Firm initiated recall is complete. REASON Platelets with a decreased platelet count were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AK. _______________________ PRODUCT Human Skin, Recall # B-1030-2. CODE Unit 02004-001 and 02004-002. RECALLING FIRM/MANUFACTURER Central Texas Regional Blood and Tissue Center, Austin, TX, by telephone and fax on February 20 and by letter February 21, 2002. Firm initiated recall is complete. REASON Human Skin, collected from a donor who subsequently tested positive for antibody to the Hepatitis B core antigen (anti-HBc) by another tissue procurement organization, was distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION TX. _______________________ PRODUCT Platelets, Pheresis, Recall # B-1034-2. CODE Units 7305426 - triple collection. RECALLING FIRM/MANUFACTURER Manatee Community Blood Center, Bradenton, FL, by telephone on November 9, 2001. Firm initiated recall is complete. REASON Blood products, with an extended expiration date, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION FL. ______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-1041-2; b) Red Blood Cells, Irradiated, Recall # B-1042-2; c) Red Blood Cells, Recall # B-1043-2; d) Platelets, Recall # B-1044-2. CODE a) Units 3766496, 3783247,3690143; b) Unit 3558717; c) Units 3634313, 3296209, 3153661, 2990884, 2896390, 2855360, 2671789; d) Units 3690143, 3634313, 3558717, 3153661, 2896390, 2855360; e) Units 3871294, 3634313, 3558717. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by fax dated January 10, 2001, and by letter dated August 29, 2001. 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 17 units. DISTRIBUTION TX, NY, FL and NJ. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-1046-2; CODE Unit numbers 9222711A, 9222711B, and 9222711C. RECALLING FIRM/MANUFACTURER Coral Blood Services, Inc., Scarborough, ME, by telephone on November 21 and by letter dated November 23, 2001. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION ME. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1047-2; b) Platelets, Recall # B-1048-2. CODE a) and b) Unit number 0694114. RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter on December 10, 2001. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to medication with the drug Proscar, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OH and KY. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1049-2. CODE Unit number 12M13817. RECALLING FIRM/MANUFACTURER The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on January 10 and by letter dated January 15, 2002. Firm initiated recall is complete. REASON Blood product, collected from an ineligible donor due to a low hemoglobin value, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NC. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1050-2; b) Recovered Plasma, Recall # B-1051-2. CODE a) and b)Unit numbers 01GJ38388 and 01GJ41651. RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY, by letters dated June 26, 2001. Manufacturer: American Red Cross Blood Services, Syracuse, NY. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to medication with the drug Proscar, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION NY and Switzerland. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1052-2; b) Platelets, Recall #B-1053-2. CODE a) Unit numbers 01LS30019, 01LS28803, and 01LS27855; b) Unit numbers 01LS28803 and 01LS27855 RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY, by letter June 28, 2001. Manufacturer: American Red Cross Blood Services, Hamburg, NY. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION NY. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1054-2; b) Recovered Plasma, Recall # B-1055-2. CODE a) and b) Unit numbers 8202458, 8203138, 8204813, 8206392, 8207525, 8047007, and 8051739. RECALLING FIRM/MANUFACTURER LifeSource Blood Services, Glenview, IL, by telephone on April 10 and September 27, 2001, and by letters on April 13, 2001 and September 28, 2001. Firm initiated recall is complete. REASON Blood products, collected from ineligible donors due to medication with the drug Methotrexate, were distributed. VOLUME OF PRODUCT IN COMMERCE 14 units. DISTRIBUTION IL, Switzerland and Scotland. _______________________ PRODUCT Red Blood Cells, recall # B-1056-2. CODE Unit numbers GX30901, GX35351, and GX37768. RECALLING FIRM/MANUFACTURER Blood Bank of San Bernadino and Riverside Counties, San Bernadino, CA, by letter on May 30, 2001. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1057-2. CODE Unit number 10712-0149. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ, by letter dated November 5, 2001. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AZ. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall #B-1058-2. CODE Unit number GK24900 (distributed as two split units). RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated September 10, 2001. Manufacturer: Tri-Counties Blood Bank, Santa Barbara, CA. Firm initiated recall is complete. REASON Blood product, that was labeled leukoreduced but was not tested to determine the white blood cell count as required in the firm's standard operating procedures, was distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0321-2. CODE Unit numbers 10720-0914 and 10720-5518. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ, by telephone on October 31, 2001 and by letter dated November 28, 2001. Firm initiated recall is complete. REASON Blood products that were out of controlled storage for more than 30 minutes were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION AZ. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0601-2. CODE Unit number 04FN14410. RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA, by telephone on June 15 and by letter dated June 21, 2001. Firm initiated recall is complete. REASON Blood product, that was found to be out of specification for red blood cell recovery, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VT. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-0967-2; b) Cryoprecipitated AHF, Recall # B-0968-2; c) Recovered Plasma, Recall # B-0969-2. CODE a), b) and c) Unit number 10626-5833. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ., by letter dated December 6, 2000. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to a history of a human tissue transplant in the previous 12 months, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION AZ and Switzerland. _______________________ PRODUCT Recovered Plasma, Recall # B-0973-2. CODE Unit numbers 15008-6865 and 15006-5474. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Lubbock, TX, by letter dated October 3, 2001. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to a history of ulcerative colitis and medication with the drug Asacol, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION TX and CA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0978-2. CODE Unit number 15386-8043 (distributed as 2 split units). RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Lubbock, TX, by letter dated August 30, 2001. Firm initiated recall is complete. REASON Blood product, collected on an apheresis machine where there was no documentation of evaluation of the filter assemblies as required, was distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION TX. _______________________ PRODUCT Fresh Frozen Plasma, Recall # B-1007-2. CODE Unit number 20FC14453. RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, Lewis and Clark Region, Boise, ID, by telephone on May 8, 2000. Manufacturer: American Red Cross Blood Services, Missoula, MT. Firm initiated recall is complete. REASON Blood product, corresponding to a unit of Red Blood Cells that may have been bacterially contaminated with Propionibacterium acnes, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MT. _______________________ PRODUCT Red Blood Cell, Recall # B-1031-2. CODE Unit 7138553. RECALLING FIRM/MANUFACTURER Manatee Community Blood Centers, Inc., Bradenton, FL, by telephone on January 7, 2000. Firm initiated recall is complete. REASON Blood product, labeled with an extended expiration date, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION FL. _______________________ PRODUCT Source Leukocytes, Recall # B-1045-2. CODE Units 3871294, 3634313, 3558717. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by fax on January 10, 2001, and by letter dated August 29, 2001. 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 TX, NY, FL and NJ.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________ PRODUCT PT-One Cards. Recall # Z-0678-2. CODE 308020107 and 308020101. RECALLING FIRM/MANUFACTURER Recalling Firm: Cardiovascular Diagnostics, d/b/a Pharmanetics, Inc., Morrisville, NC, by letter on July 5, 2001. Manufacturer: Cardiovascular Diagnostics, Inc., d/b/a Pharmanetics, Inc., Morrisville, NC. Firm initiated recall is complete. REASON Incorrect inserts were found in some boxes of the product. VOLUME OF PRODUCT IN COMMERCE 94 boxes/9,400 cards. DISTRIBUTION AZ, CA, IA, MN, NY, OH, OR and PA. _______________________ PRODUCT Pentax brand Video Colonoscopes and Fiber Colonoscopes. The Angle Wire Receptacle component is the affected part. Recall # Z-0680-2/Z-0681-2. Common Names: Video Colonoscope; Fiber Colonoscope Classification Name: Colonoscope (CFR 876.1500). CODE MODEL # PMN # 510(k)REF. # OPERATOR MANUAL # Video Colonoscopes: XEC-3830L K951574 EC-3800L Z231 R05 EC-2930F K951574 EC-3800L Z231 R05 EC-2930FK K951574 EC-3800L Z270 R01 EC-3400F K951574 EC-3800L Z207 R04 EC-3400L K951574 EC-3800L Z207 R04 EC-3430F K951574 EC-3800L Z207 R04 EC-3430FK K951574 EC-3800L Z270 R01 EC-3430L K951574 EC-3800L Z231 R05 EC-3430LK K951574 EC-3800L Z270 R01 EC-3430LZ K951574 EC-3800L Z231 R05 EC-3431L K951574 EC-3800L Z237 R06 EC-3440F K961570 EC-3840L Z237 R06 EC-3440L K961570 EC-3840L Z237 R06 EC-3800F K951574 EC-3800L Z270 R01 EC-3800L K951574 Original Z207 R04 EC-3800TL K951579 Original Z213 R02 EC-3801F K951574 EC-3800L Z207 R04 EC-3801F2 K951574 EC-3800L Z207 R04 EC-3801L K951574 EC-3800L Z207 R04 EC-3801L30 K951574 EC-3800L Z207 R04 EC-3801S2 K951574 EC-3800L Z207 R04 EC-380LP K951574 EC-3800L Z207 R04 EC-381L30 K951574 EC-3800L Z207 R04 EC-3830F K951574 EC-3800L Z207 R04 EC-3830FK2 K951574 EC-3800L Z207 R04 EC-3830L K951574 EC-3800L Z231 R05 EC-3830LK K951574 EC-3800L Z207 R04 EC-3830LZ K951574 EC-3800L Z242 R05 EC-3830LZK K951574 EC-3800L Z242 R05 EC-3830M2 K951574 EC-3800L Z231 R05 EC-3830MK K951574 EC-3800L Z207 R04 EC-3830MK2 K951574 EC-3800L Z207 R04 EC-3830S2 K951574 EC-3800L Z207 R04 EC-3830TL K951579 EC-3800TL Z231 R05 EC-3830TLK K951579 EC-3800TL Z270 R01 EC-3831L K951574 EC-3800L Z231 R05 EC-3831LK K951574 EC-3800L Z207 R04 EC-3831TL K951574 EC-3800L Z231 R05 EC-3832L K951574 EC-3800L Z231 R05 EC-3840F2 K961570 EC-3840L Z237 R05 EC-3840L K961570 Original Z237 R05 EC-3840LK K961570 EC-3840L Z207 R04 EC-3840TL K961563 Original Z237 R06 EC-3841LK K961570 EC-3840L Z207 R04 EC-38TL30 K951579 EC-3800TL Z207 R04 EC-O2930MK K951574 EC-3800L Z270 R01 EC-O2930FK K951574 EC-3800L Z270 R01 ECX-3830L K951574 EC-3800L Z231 R05 Fiber Colonoscopes: FC-34FH K951580 FC-38LH Z127 FC-38FV K951578 FC-38LX Z171 R04 FC-38FX2 K951578 FC-38LX Z140 FC-38LA K822846 Original FC-38LA FC-38LH K951580 Original Z127 FC-38LP K951580 FC-38LH Z150 R02 FC-38LV K951578 FC-38LX Z171 R04 FC-38LX K951578 Original Z140 FC-38MX K951578 FC-38LX Z140 FC-38SH K951580 FC-38LH Z127 FC-38SX2 K951578 FC-38LX Z140 FC-38TLH K951575 Original Z127 FC-P34 K951580 FC-38LH Z127 FC-PP34L K951580 FC-38LH Z127 (Note: The 510(k) Model Reference # is the model on the PMN, clearance reference is made as 'not significant change'). There are 3,630 affected Serial Numbers involved in this action: Video Colonoscopes: Model Number Serial Number(s) ~XEC-3830L A01002 EC-2930F A01001, A01002, A01003, A01007 EC-2930FK A01001, A01002, A01003 EC-3400F A01016, A01024, A01025, A01036, A01042, A01047, A01056, A01058, A01060, A01063, A01064, A01074, A01076, A01084, A01090, A01092, A01093, A01099, A01101, A01105, A01106, A01112, A01114, A01119, A01122, A01124, A01131, A01137, A01141, A01142, A01145, A01159, A01161, A01162, A01172, A01176, A01177, A01179, A01187, A01210, A01211, A01212, A01223, A91001, B01241, B01245, B01250, B01252, C01280, C01281, C01282, C01291, C01296, C01311 EC-3400L A01014, A01015, A01018, A01020, A01022, A01023, A01026, A01030, A01037, A01038, A01039, A01052, A01064, A01065, A01067, A01068, A01072, B01084, C01091, C01093, C01094, C01096, C01098, C01099, C01100, C01109, C01111, C01113, C01116, C01122, C01124, C01125, C01127, C01135, C01140, C01147, C01148, C01150, C01154, C01155, C01156, C01159, C01164, C01165, C01171, C01175, C01182, C01183, C01187, C01188, C01189, C01190, C01191, C01193, C01195, C01199, C01201, C01202, C01203, C01205, C01207 EC-3430F A01011, A01013, A01014, A01016, A01017, A01020, A01027, A01032, A01039, A01046, A01048, A01050, A01051 EC-3430FK A01001, A01012, A01013, A01015 EC-3430L 1015A, A01001, A01012, A01014, A01017, A01019, A01020, A01026, A01029, A01030, A01031, A01032, A01033, A01034, A01035, A01037, A01042, A01045, A01050, A01052, A01054, A01056, A01059, A01060, A01062, A01063, A01064, A01065, A01067, A01070, A01072, A01073, A01075, A01077, A01078, A01079, A01080, A01081, A01083, A01084, A01089, A01090, A01091, A01093, A01095, A01096, A01097, A01098, A01102, A01105, A01110, A11178, A11180, A11181, A11182, A11183, A11184, A11185, A11186, A11190, A11191, A11192, A11193, A11194, A11195, A11196, A11197, A11198, A11202, A11206, A11207, A11209, A11210, A11211, A11214, A11215, A11217, A11222, A11223, A11224, A11225, A11227, A11229, A11232, A11235, A11236, A11237, A11238, A11243, A11246, A11249, A11250, A11251, A11252, A11253, A11257, A11260, A11262, A11265, A11266, A11267, A11269, A11270, A11272, A11273, A11274, A11275, A11276, A11277, A11278, A11279, A11282, A11284, A11286, A11288, A11289, A11290, A11291, A11294, A11295, A11299, A11301, A11302, A11306, A11307, A11308, A11309, A11310, A11311, A11312, A11314, A11315, A11316, A11318, A11319, A11321, A11322, A11323, A11325, A11330, A11331, A11332, A11333, A11334, A11335, A11336, A11344, A11345, A11346, A11347, A11350, A11357, A11361, A11362, A11366, A11367, A11368, A11370, A11373, A11375, A11376, A11377, A11378, A11381, A11382, A11383, A11384, A11385, A11388, A11389, A11392, A11395, A11399, A11402, A11403, E110535, T01117, T01118, T01119, T01120, T01121, T01123, T01124, T01125, T01126, T01127, T01128, T01129, T01130, T01133, T01134, T01135, T01139, T01141, T01142, T01143, T01145, T01146, T01147, T01148, T01149, T01150, T01152, T01154, T01155, T01158, T01161, T01162, T01163, T01165, T01166, T01168, T01169, T01172, T01173, T01174, T01175 EC-3430LK A01001, A01002, A01013, A01014, A01015, A01016, A01017, A01018, A01019, A01020, A01021, A01023, A01024, A01025, A01026, A01027, A01028, A01029, A01030, A01031, A01032, A01033, A01034, A01035, A01036, A01037, A01038, A01039, A01042, A01044, A01045, A01046, A01047, A01048, A01049, A01050, A01051, A01052, A01056, A01057, A01061, A01062, A01063, A01064, A01065, A01066, A01067, A01068, A01069, A01070, A01071, A01072, A01074, A01076, A01077, A01078, A01079, A01080, A01081, A01082, A01083, A01084, A01085, A01086, A01087, A01088, A01089, A01091, A01092, A01094, A01095, A01099, A01100, A01101, A01102, A01103, A01104, A01105, A01106, A01107, A01108, A01109, A01110, E01194, E01220 EC-3430LZ A01001 EC-3431L A01001, A01002, A01003, A01005 EC-3440F A01019 EC-3440L A01012, A01014, A01020, A01021, A01022, A01023, A01027, A01028, A01030, A01031, A01032, A01033, A01034, A01035, A01036, A01037, A01038, A01042, A01044, A01045, A01046, A01047, A01048, A01051, A01053, A01056, A01059, A01061, A01063, A01064, A01065, A01066, A01069, A01071, A01074, A01075, A01081, A01082, A01086, A01087, A01088, A01090, A01091, A01093, A01100, A01110, E010121 EC-3800F C92145 EC-3800 A71012, A71013, A71014, A71016, A71017, A71018, A71023, A71025, A71029, A71033, A71036, A71039, A71047, A71049, A71055, A71058, A71060, A71065, A81080, A81081, A81082, A81089, A81091, A81099, A81100, A81101, A81102, A81103, A81104, A81107, A81109, A81115, A81116, A81117, A81123, A81127, A81135, A81146, A81148, A81153, A81155, B91161, B91163, B91166, B91169, C02290, C02293, C02294, C02297, C02298, C91179, C91180, C91186, C91188, C92200, C92201, C92204, C92205, C92209, C92212, C92213, C92214, C92216, C92217, C92220, C92221, C92224, C92232, L01002, L01005, P98001 EC-3800TL A01012, A01014, A01019, A01021, A01022, A01023, A01025, A01026, A01036, A01037, A01039, A01041, A01042, A01043, A01044, A01046, A01055, A01056, A01059, A01060, A01065, A01069, A01074, A01075, A01076, A01080, A01082, A01083, A01084, A01090, A01094, A01095, A01100, A01101, A01102, A01116, A01118, A01136, A01137, A01138, A01141, A01148, A01149, A01150, A01151, A01153, A01154, A01156, A01160, A01161, A01172, A01177, A01181, A01183, A01184, A01185, A01187, A01191, A01192, A01197, A01199, A01204, A01206, A01209, A01217, A01220, A01223, A01225, A01232, A01233, A01234, A01237, A01238, A01240, A01243, A01247, A01250, A01251, A01252, A01254, A01255, A01257, A01261, A01266, A01270, A01271, A01273, A01274, A01275, A01280, A01285, A01289, A01290, A01291, A01296, A01298, A01299, A01300, A01310, A01311, A01312, A01313, A01318, A01326, A01327, A01328, A01331, A01332, A01336, A01337, A01338, A01341, A01342, A01348, A01352, A01356, A01359, A01360, A01361, A01363, A01365, A01367, A01369, A01370, A01377, A01387, A01391, A01404, A01406, A01407, A01408, A01411, A01424, A01425, A01435, A01436, A01438, A01439, A01446, A01448, A01461, A01467, A01469, A01472, A01474, A01482, A01486, A01490, A01493, A01496, A01497, A01500, A01502, A01503, A01505, A01513, A01514, A01518, A01520, A01521, A01522, A01524, A01531, A01532, B01537, B01538, B01540, B01541, B01543, B01547, B01553, B01556, B01559, B01562, B01563, B01564, B01566, B01572, B01573, B01574, B01579, B01582, B01587, B01596, B01599, B01602, B01604, B01606, B01608, B01610, B01613, B01615, B01618, B01620, B01621, B01624, B01625, B01627, B01630, B01637, B01640, C01643, C01645, C01648, C01651, C01654, C01655, C01659, C01662, C01665, C01668, C01669, C01670, C01675, C01676, C01678, C01679, C01681, C01682, C01687, C01694, C01700, C01719, C01722, C01723, C01726, C01727, C01740, C01742, C01745, C01746, C01753, C01755, C01772, C01778, C01790, C01796, C01809, C01812, C01813, C01815, C01816, C01820, C01821, C01822, C01824, C01827, C01828, C01833, C01834, C01835, C01836, C01838, C01841, C01843, P98005 EC-3801F A01161 EC-3801F2 A01048 EC-3801 920001, A01012, A01013, A01014, A01015, A01016, A01017, A01018, A01019, A01020, A01029, A01031, A01032, A01036, A01038, A01041, A01043, A01048, A01049, A01051, A01054, A01059, A01060, A01066, A01067, A01070, A01076, A01077, A01079, A01080, A01085, A01088, A01089, A011001, A011007, A011013, A011020, A011024, A011025, A011030, A011032, A011033, A011034, A01104, A011047, A011051, A011053, A011054, A011057, A011058, A01106, A011060, A011061, A011062, A011066, A011067, A011072, A011079, A011082, A011086, A011087, A011089, A011090, A011091, A011094, A011095, A011096, A011097, A011099, A01110, A011102, A011103, A011104, A011111, A011114, A011115, A011121, A011124, A011128, A011129, A011131, A011133, A01115, A011155, A011156, A011158, A011160, A011163, A011165, A011170, A011171, A011172, A011175, A011176, A011177, A011179, A011183, A011186, A011187, A011189, A01120, A011201, A011204, A011219, A011221, A01123, A011230, A011240, A011241, A011242, A011243, A011246, A011255, A01126, A011260, A011265, A011274, A011276, A011280, A011285, A011286, A011288, A01129, A011297, A011298, A011299, A011301, A011302, A011309, A011310, A011311, A011315, A011317, A011321, A011324, A011329, A01133, A011330, A011331, A011332, A011333, A011336, A011342, A011343, A011344, A011347, A011348, A011349, A01135, A011350, A011357, A011360, A011362, A011363, A011373, A011379, A01138, A011383, A011386, A011387, A011389, A011390, A011391, A011392, A011393, A011394, A011395, A011396, A011397, A011402, A011406, A011407, A011408, A011409, A011416, A01142, A011422, A011423, A01143, A011433, A011436, A011437, A011439, A011442, A011445, A011447, A011448, A011451, A011453, A011455, A011456, A011457, A011462, A011463, A011468, A011469, A01147, A011471, A011473, A011484, A011485, A011488, A011489, A01149, A011493, A011494, A011495, A01150, A011501, A011502, A011504, A011505, A011506, A01151, A011519, A011523, A011524, A011525, A011527, A01153, A011532, A011534, A011535, A011536, A011538, A011539, A01154, A011540, A011542, A011543, A011544, A011547, A011554, A011555, A011559, A011562, A011564, A011566, A011567, A011568, A011572, A011573, A011574, A011578, A011579, A011581, A011583, A011588, A011592, A011593, A011594, A011595, A011598, A011599, A011600, A011601, A011604, A011605, A011607, A011618, A011621, A011625, A01163, A011630, A011632, A011635, A011638, A011641, A011651, A011654, A011655, A011666, A011673, A011676, A011692, A011695, A011697, A011702, A011707, A011709, A011712, A011714, A011715, A011718, A01172, A011720, A011722, A011732, A011735, A011738, A011740, A011742, A011743, A011746, A011747, A011750, A011763, A011765, A011774, A011778, A01178, A011789, A011793, A011797, A011798, A011803, A011811, A01182, A011820, A011825, A01183, A011836, A011837, A011838, A011842, A011843, A011844, A011846, A011847, A01185, A011853, A011866, A011868, A01187, A011871, A011876, A011878, A011890, A011892, A011895, A011914, A011916, A011917, A011918, A011919, A011923, A011925, A011929, A011931, A011933, A011936, A011937, A01194, A011940, A011945, A011946, A011947, A01195, A011959, A011962, A011966, A011969, A01197, A01198, A01199, A011996, A011998, A01200, A012006, A012007, A01201, A012028, A012029, A012032, A012033, A012035, A012036, A012039, A012040, A012042, A012048, A012049, A012071, A012079, A012080, A012081, A012082, A012083, A012084, A012085, A01210, A012104, A012108, A012110, A012111, A01212, A012120, A012129, A01213, A012131, A012132, A012135, A012138, A012139, A012140, A012147, A012148, A012153, A012167, A01217, A012172, A012174, A012180, A012182, A012184, A012186, A012187, A012188, A012189, A012191, A012193, A012196, A012206, A01221, A012215, A012217, A012218, A012219, A012223, A012226, A012227, A012228, A01224, A012240, A012245, A012246, A012251, A012259, A012260, A012261, A012270, A012273, A012277, A012279, A01228, A012280, A012283, A012292, A012294, A01230, A012302, A012310, A012312, A012313, A012316, A012318, A01232, A012320, A012322, A012327, A012328, A012330, A012332, A012334, A012337, A012339, A01234, A012342, A012344, A012346, A012347, A01235, A012354, A012356, A012358, A012360, A012362, A012364, A012365, A012368, A01237, A012376, A012382, A012384, A012386, A012387, A012388, A012389, A01239, A012390, A012391, A012397, A012399, A012403, A012404, A012408, A01241, A012411, A012417, A012421, A012423, A012424, A012425, A012426, A012427, A012429, A01243, A012431, A012435, A012436, A012437, A012438, A012439, A01244, A012440, A012443, A012446, A012447, A012448, A012449, A01245, A012452, A01246, A01248, A01250, A01251, A01252, A01253, A01255, A01259, A01262, A01264, A01272, A01292, A01295, A01297, A01298, A01302, A01303, A01305, A01307, A01308, A01310, A01312, A01319, A01320, A01321, A01325, A01326, A01328, A01333, A01346, A01349, A01350, A01352, A01356, A01357, A01359, A01363, A01364, A01369, A01370, A01371, A01373, A01374, A01375, A01376, A01377, A01400, A01403, A01404, A01405, A01413, A01418, A01423, A01426, A01430, A01432, A01433, A01434, A01435, A01437, A01448, A01450, A01457, A01458, A01463, A01464, A01467, A01469, A01470, A01472, A01473, A01474, A01475, A01477, A01485, A01489, A01490, A01499, A01509, A01511, A01513, A01517, A01518, A01527, A01528, A01529, A01531, A01534, A01546, A01558, A01567, A01575, A01577, A01578, A01580, A01581, A01585, A01589, A01590, A01596, A01602, A01610, A01611, A01617, A01618, A01620, A01625, A01626, A01630, A01632, A01641, A01644, A01645, A01647, A01648, A01656, A01659, A01662, A01665, A01666, A01681, A01686, A01689, A01690, A01691, A01692, A01698, A01699, A01715, A01722, A01724, A01728, A01730, A01735, A01736, A01739, A01752, A01756, A01761, A01764, A01765, A01768, A01770, A01777, A01784, A01787, A01793, A01797, A01802, A01806, A01807, A01810, A01812, A01814, A01831, A01837, A01838, A01839, A01840, A01843, A01844, A01847, A01849, A01857, A01859, A01861, A01863, A01865, A01866, A01869, A01872, A01875, A01876, A01877, A01879, A01882, A01886, A01896, A01898, A01899, A01900, A01901, A01909, A01911, A01914, A01917, A01920, A01921, A01926, A01927, A01935, A01936, A01937, A01943, A01945, A01946, A01947, A01948, A01949, A01950, A01951, A01952, A01955, A01968, A01970, A01973, A01974, A01981, A01986, A01987, A01993, A01L01, A81097, B012460, B012467, B012468, B012473, B012476, B012482, B012490, B012498, B012508, B012509, B012510, B012522, B012524, B012527, B012530, B012535, B012537, B012538, B012542, B012550, B012551, B012552, B012560, B012568, B012572, B012576, B012580, B012582, B012587, B012590, B012599, B012602, B012610, B012611, B012613, C012629, C012643, C012648, C012653, C012655, C012670, C012675, C012676, C012677, C012681, C012682, C012688, C012691, C012694, C012697, C012716, C012717, C012718, C012722, C012723, C012725, C012727, C012728, C012739, C012740, C012744, C012749, C012754, C012756, C012777, C012788, C012794, C012797, C012798, C012808, C012809, C012810, C012811, C012812, C012825, C012828, C012846, C012856, C012866, C012867, C012869, C012870, C012871, C012876, C012884, C012886, C012890, C012891, C012893, C012901, C012928, C012929, C012930, C012937, C012941, C012962, C012967, C012968, C012972, C012973, C012984, C012988, C012992, C012996, C012997, C013002, C013004, C013007, C013008, C013009, C013011, C013015, C013021, C013022, C013028, C013029, C013030, C013040, C013042, C013045, C013048, C013049, C013055, C013064, C013070, C013078, C013080, C013082, C013084, C113098, C113100, C113106, C113108, C113113, C113117, C113141, L01006, NY011269, NY01394, NY01785, NY01809, P98002 EC-3801L30 B012561 EC-3801S2 A01012 EC-380LP A01016, A01189, A01193 EC-381L30 A012378 EC-3830F A01030 EC-3830FK2 A01012, A01014, A01017, A01020, A01021, A01022 EC-3830L 1070A, 1081A, 1085A, 1149A, 1162A, 1187A, A01001, A01001T, A01002, A01002T, A01005T, A01012, A01013, A01014, A01015, A01017, A01018, A01020, A01021, A01022, A01024, A01025, A01028, A01034, A01037, A01041, A01042, A01043, A01045, A01046, A01048, A01049, A01050, A01051, A01053, A01056, A01057, A01058, A01060, A01061, A01063, A01067, A01068, A01073, A01075, A01076, A01077, A01082, A01083, A01084, A01085, A01086, A01087, A01088, A01091, A01093, A01100, A01103, A01104, A01106, A01111, A01112, A01113, A01119, A01127, A01129, A01130, A01133, A01139, A01141, A01142, A01144, A01145, A01147, A01149, A01157, A01158, A01165, A01168, A01173, A01175, A01176, A01181, A01190, A01191, A01192, A01194, A01196, A01198, A01205, A01209, A01214, A01216, A01217, A01218, A01222, A01229, A01230, A01231, A01234, A01237, A01240, A01242, A01246, A01248, A01250, A01251, A01254, A01255, A01256, A01261, A01263, A01264, A01266, A01274, A01275, A01280, A01284, A01286, A01287, A01288, A01310, A01316, A01318, A01320, A01323, A01324, A01330, A01331, A01334, A01336, A01340, A01341, A01342, A01344, A01345, A01348, A01349, A01350, A01351, A01352, A01354, A01356, A01358, A01360, A01361, A01362, A01364, A01366, A01367, A01372, A01376, A01377, A01382, A01383, A01386, A01389, A01391, A01392, A01393, A01397, A01400, A01403, A01405, A01411, A01414, A01416, A01419, A01421, A01424, A01428, A01429, A01430, A01445, A01448, A01449, A01456, A01457, A01462, A01463, A01467, A01468, A01469, A01471, A01474, A01475, A01478, A01481, A01485, A01487, A01489, A01496, A01497, A01499, A01502, A01506, A01507, A01509, A01510, A01511, A01512, A01513, A01514, A01515, A01516, A01517, A01519, A01524, A01526, A01535, A01536, A01537, A01538, A01539, A01540, A01542, A111000, A111001, A111002, A111003, A111004, A111005, A111007, A111010, A111011, A111013, A111014, A111015, A111016, A111017, A111019, A111020, A111022, A111024, A111025, A111026, A111028, A111030, A111032, A111033, A111034, A111035, A111036, A111037, A111040, A111042, A111045, A111047, A111048, A111049, A111050, A111052, A111055, A111057, A111058, A111060, A111061, A111062, A111063, A111072, A111074, A111078, A111079, A111084, A111086, A111087, A111089, A111092, A111099, A111101, A111105, A111106, A111109, A111110, A111115, A111116, A111117, A111123, A111126, A111127, A111128, A111129, A111130, A111133, A111134, A111135, A111138, A111139, A11705, A11709, A11713, A11716, A11718, A11720, A11721, A11722, A11724, A11725, A11726, A11727, A11730, A11731, A11733, A11734, A11735, A11736, A11737, A11739, A11740, A11742, A11744, A11746, A11747, A11749, A11751, A11752, A11755, A11760, A11761, A11762, A11764, A11765, A11767, A11768, A11770, A11774, A11775, A11776, A11777, A11778, A11779, A11782, A11784, A11785, A11786, A11787, A11788, A11789, A11793, A11795, A11800, A11802, A11804, A11805, A11806, A11810, A11812, A11814, A11817, A11818, A11819, A11823, A11824, A11825, A11827, A11831, A11832, A11834, A11835, A11836, A11838, A11839, A11840, A11842, A11843, A11844, A11845, A11847, A11848, A11851, A11853, A11854, A11857, A11859, A11860, A11861, A11864, A11867, A11868, A11869, A11871, A11872, A11877, A11878, A11881, A11882, A11885, A11887, A11890, A11892, A11894, A11896, A11897, A11900, A11901, A11903, A11904, A11909, A11912, A11913, A11914, A11915, A11916, A11918, A11919, A11922, A11925, A11927, A11930, A11936, A11941, A11947, A11950, A11951, A11953, A11954, A11956, A11957, A11960, A11961, A11965, A11966, A11967, A11969, A11970, A11976, A11978, A11985, A11988, A11989, A11993, A11996, A11997, A11998, DS9006, P20006, P20007, T01545, T01546, T01547, T01549, T01551, T01553, T01557, T01558, T01561, T01562, T01563, T01566, T01570, T01571, T01572, T01573, T01576, T01578, T01580, T01583, T01585, T01587, T01590, T01593, T01599, T01601, T01607, T01608, T01609, T01611, T01613, T01614, T01619, T01620, T01622, T01623, T01626, T01628, T01630, T01632, T01633, T01634, T01636, T01638, T01639, T01641, T01642, T01656, T01659, T01661, T01663, T01664, T01668, T01669, T01681, T01682, T01683, T01686, T01690, T01691, T01694, T01695, T01696, T01697 EC-3830LK A01011, A01012, A01015, A01016, A01017, A01018, A01020, A01021, A01022, A01023, A01026, A01030B, A01031, A01032, A01033, A01034, A01035, A01037, A01040, A01044, A01048, A01050, A01051, A01052, A01053, A01054, A01057, A01060, A01063, A01064B, A01065, A01067, A01069, A01070, A01071, A01072, A01073, A01075, A01080, A11173, A11176B, A11180, A11181, A11182, A11184, A11187B, A11188, A11189, A11190, A11191, A11193, A11194, A11195, A11196, A11197, A11198, A11199, A11200, A11201, A11202, A11203, A11207, A11208B, A11209, A11211, A11216, A11217, A11221, A11224, A11225, A11226, A11227, A11228, A11229, A11230, A11231, A11232, A11234, A11236B, A11237, A11240, A11241, A11242, A11243, A11245, A11248, A11251, B11256, B11257, B11258, B11259, B11260, B11261, B11262, B11263, B11265, B11266, B11267, B11268, B11269, B11272, B11273, B11274, B11275, B11276, B11282, B11283, B11284, B11287, B11289, B11290, B11291, B11292, B11293, B11296, B11298, B11299, B11300, B11301, B11302, B11304, B11305, B11306, B11308, B11309, B11310, B11311, B11312, B11313, B11316, B11317, B11319, B11324, B11325, B11328, B11329, B11330, B11331, B11332, B11335, B11336, B11337, B11338, B11340, B11341, B11342, B11343, B11345, B11350, B11352, B11356, B11357, B11358, B11359, B11361, B11362, B11363, B11365, B11366, B11370, B11372, B11373, B11374, B11375, B11376, B11379, B11381, B11383, B11384, B11385, B11386, B11387, B11388, B11389, B11390, B11391, B11392, B11393, B11395, B11396, B11397, B11398, B11400, B11402, B11403, B11410, B11413, B11414, B11419, B11420, B11421, B11422, B11423, B11427, B11428, B11430, B11432, B11436, B11437, B11439, B11440, B11441, B11442, B11444, B11445, B11449, B11450, B11451, B11452, B11454, B11458, B11459, B11464, B11465, B11466, B11467, B11469, B11470, B11471, B11474, B11476, B11477, B11480, B11487, B11493, B11495, B11496, B11497, B11499, B11502, B11503, B11504, B11506, B11510, B11511, B11512, B11513, B11514, B11515, B11516, B11517, B11522, B11523, B11524, B11525, B11526, B11527, B11528, B11530, B11531, B11532, B11534, B11536, B11537, B11541, B11544, B11549, B11551, B11553, B11554, B11556, B11558, B11559, B11560, B11561, B11562, B11564, B11565, B11567, B11568, B11571, B11574, B11575, B11578, B11580, B11582, B11583, B11585, B11586, B11587, B11588, B11589, B11590, B11591, B11592, B11594, B11595, B11596, B11601, B11602, B11603, B11604, B11606, B11608, B11610, B11612, B11613, B11614, B11616, B11617, B11620, B11621, B11623, B11624, B11625, B11626, B11635, B11636, B11637, B11638, B11639, B11640, B11641, B11643, B11649, B11650, B11652, B11653, B11656, B11657, B11831, C11659, C11664, C11665, C11674, C11675, C11676, C11677, C11680, C11683, C11685, C11686, C11688, C11689, C11691, C11694, C11695, C11696, C11697, C11698, C11699, C11701, C11703, C11704, C11705, C11706, C11707, C11709, C11710, C11711, C11712, C11713, C11714, C11715, C11716, C11717, C11718, C11719, C11721, C11722, C11723, C11724, C11725, C11726, C11729, C11741, C11744, C11746, C11748, C11749, C11753, C11755, C11763, C11764, C11765, C11766, C11767, C11768, C11769, C11770, C11772, C11773, C11775, C11777, C11778, C11779, C11780, C11781, C11782, C11783, C11784, C11786, C11787, C11788, C11790, C11791, C11793, C11795, C11797, C11798, C11800, C11802, C11805, C11806, C11807, C11808, C11809, C11810, C11813, C11815, C11818, C11819, C11820, C11821, C11823, C11825, C11828, C11829, C11830, C11832, C11833, C11838, C11840, C11841, C11842, C11843, C11844, C11845, C11846, C11847, C11849, C11850, C11851, C11853, C11855, C11856, C11857, C11858, C11859, C11860, C11862, C11863, C11868, C11869, C11870, C11873, C11874, C11875, C11878, C11880, C11883, C11884, C11885, C11886, C11887, C11888, C11889, C11891, C11892, C11893, C11894, C11895, C11896, C11897, C11898, C11899, C11900, C11901, C11902, C11903, C11904, C11905, C11906, C11907, C11909, C11910, C11911, C11913, C11914, C11915, C11916, C11918, C11919, C11922, C11923, C11924, C11925, C11926, C11928, C11930, C11931, C11933, C11934, C11935, C11937, C11940, C11941, C11942, C11943, C11944, C11945, C11947, C11949, C11951, C11953, C11954, C11955, C11956, C11957, C11958, C11963, C11965, C11966, C11968, C11969, C11970, C11971, C11973, C11975, C11976, C11977, C11978, C11979, C11980, C11981, C11982, C11983, C11984, C11985, C11986, C11987, C11988, C11989, C11990, DS2001, P99007, T01082, T01083, T01084B, T01085, T01087, T01088, T01091, T01092, T01094, T01095, T01096, T01098, T01099, T01100, T01103 T01105, T01107, T01108, T01109, T01114, T01115, T01118, T01120, T01121, T01122, T01124, T01125, T01126, T01127, T01128, T01131, T01132, T01134, T01135, T01136, T01137, T01142, T01143, T01144, T01145, T01146, T01147, T01148, T01149, T01151, T01152, T01153, T01155, T01156, T01157, T01158, T01159, T01161, T01162, T01163, T01165, T01166, T01167, T01168, T01169 EC-3830LZ A01002, A01013, A01014, A01016, A01017, A01018, A01022, A01026, A01028, A01029, A01032, A01034, A01037, A01056 EC-3830LZK E01001 EC-3830M2 A01014 EC-3830MK A01036 EC-3830MK2 A01016, A01022, A01024, A01026 EC-3830S2 A01016, A01017 EC-3830TL 1020A, 1021A, 1115A, 1127A, 1134A, A01012, A01016, A01017, A01018, A01019, A01020, A01022, A01023, A01024, A01025, A01026, A01029, A01030, A01031, A01032, A01035, A01036, A01039, A01040, A01043, A01045, A01046, A01047, A01048, A01049, A01050, A01051, A01052, A01053, A01055, A01056, A01057, A01058, A01059, A01060, A01061, A01069, A01072, A01082, A01085, A01086, A01092, A01095, A01096, A01098, A01099, A01102, A01105, A01110, A01111, A01115, 01120, A01122, A01123, A01125, A01129, A01138, A01139, A01141, A01144, A01148, A01151, A01153, A01155, A01161, A01163, A01164, A01169, A01171, A01173, A01174, A01175, A01176, A01177, A01193, A01195, A01197, A01200, A01202, A01207, A01209, A01214, A01215, A01216, A01221, A01222, A01223, A01224, A01225, A01227, A01228, A01229, A01230, A01231, A01232, A01233, A01234, A01235, A01236, A01240, A01243, A01246, A01247, A01249, A01250, A01251, A01252, A01254, A01255, A01260, A01261, A01269, A01270, A01274, A01277, A01279, A01288, A01290, A01291, A01292, A01293, A01294, A01298, A01299, A01301, A01302, A01304, A01311, A01314, A01316, A01322, A01323, A01326, A01327, A01330, A01333, A01334, A01335, A01336, A01337, A01339, A01340, A01341, A01342, A01344, A01346, A01347, A01349, A01351, A01353, A01355, A01356, A01357, A01360, A01362, A01363, A01366, A01370, A01371, A01372, A01379, A01382, A01389, A01392, A01393, A01402, A01404, A01407, A01409, A01410, A01415, A01420, A01421, A01422, A01425, A01430, A01433, A01434, A01438, A01441, A01446, A01451, A01452, A01453, A01454, A01455, A01456, A01458, A01459, A01461, A01463, A01464, A01466, A11471, A11472, A11474, A11476, A11480, A11484, A11485, A11487, A11488, A11491, A11493, A11494, A11500, A11501, A11502, A11503, A11505, A11507, A11509, A11510, A11512, A11513, A11519, A11532, A11533, A11535, A11541, A11545, A11548, A11553, A11555, A11556, A11557, A11558, A11561, A11566, A11568, A11569, A11572, A11576, A11577, A11579, A11581, A11582, A11584, A11585, A11589, A11595, A11596, A11597, A11598, A11599, A11600, A11603, A11606, A11607, A11611, A11612, A11613, A11614, A11619, A11621, A11628, A11629, A11630, A11635, A11637, A11640, A11641, A11642, A11644, A11647, A11648, A11652, A11654, A11661, A11662, A11667, A11669, A11671, A11672, A11676, A11680, A11683, A11684, A11685, A11686, A11689, A11704, A11719, DS2002, DS9008, DS9009, P99008 EC-3830TLK A01001, A01003, A01012, A01013, A01017, A01019, A01023, A01024, A01025, A01026, A01027, A01028, A01030, A01031, A01032, A01033, A01034, A01035, A01036, A01037, A01038, E01077 EC-3831L A01002A, A01013, A01017, A01021, A01022, A01023, A01024, A01025, A01027, A01033, A01034, A01037, A01045, A01046, A01056, A01057, A01058, A01059, A01066, A01067, A01068, A01069, A01070, E11318 EC-3831LK E01001, E01002, E01003, E01005 EC-3831TL A01001, A01002, A01003 EC-3832L A01001, A01002, A01003 EC-3840F2 A01149, A01151 EC-3840L A01023, A01026, A01059, A01061, A01062, A01064, A01065, A01067, A01069, A01071, A01072, A01073, A01075, A01076, A01077, A01080, A01082, A01083, A01086, A01088, A01089, A01090, A01092, A01094, A01096, A01097, A01099, A01102, A01104, A01105, A01107, A01110, A01120, A01124, A01126, A01128, A01129, A01130, A01133, A01139, A01140, A01141, A01146, A01152, A01158, A01160, A01165, A01166, A01170, A01172, A01173, A01191, A01198, A01199, A01201, A01202, A01205, A01206, A01207, A01208, A01209, A01210, A01211, A01212, A01216, A01218, A01219, A01220, A01223, A01226, A01229, A01234, A01235, A01236, A01237, A01238, A01241, A01244, A01246, A01254, A01255, A01256, A01259, A01262, A01264, A01269, A01272, A01273, A01275, A01276, A01279, A11438, A11440, A11503, A11504, A11512, A11514, A11516, A11521, A11531, A11567, A11609, A11610, A11615, A11625, A11627, A11638, A11639, A11640, A11662, VET33 EC-3840LK A01002 EC-3840TL A01013, A01018, A01019, A01025, A01028, A01029, A01031, A01034, A01035, A01037, A01039, A01042, A01043, A01044, A01046, A01051, A01053, A01054, A01055, A01060, A01062, A01065, A01070, A01071, A01072, A01079, A01081, A01082, A01083, A01087, A01091, A01095, A01096, A01101, A01105, A01109, A01110, A01112, A01113, A01119, A01120, A01124, A01126, A01129, A01131, A01145, A01146, A01147, A01149, A01151, A01153, A01157, A01158, A01159, A01166, A01167, A01170, A01176, A01177, A01180, A01183, A01184, A01185, A01191, A01205, A01207, A01211, A01212, A01213, A01216, A01221, A01224, A01226, A01227, A01231, A01233, A01244, A01246, A01249, A01250, A01251, A01257, A01259, A01261, A01262, A01272, A01279, A11281 EC-3841LK E01001 EC-38TL30 A01295 EC-O2930FK A01001 EC-O2930MK A01001, A01002 ECX-3830L A01001 Fiber Colonoscopes: Model Number Serial Numbers FC-34FH A71019, A71020, A71026, A71039, A71042, A71046, A71052, R149 FC-34FX A01039, A91001, A91017, A91021, A91024, B01052, B01063, B01075, B01097, B01098, B01100 FC-38FV A01269, A01271, A01273 FC-38FX2 B91028, C02433 FC-38LA B91085, P40006 FC-38LH A51026, A51039, A51050, A51054, A51072, A51075, A51081, A51089, A51095, A51101, A51104, A51119, A51129, A51141, A51172, A51195, A51225, A51242, A51247, A61004, A61275, B011197, B011332, B011358, B011368, B011446, B011456, B011459, B61346, B61368, B61377, B61378, B61391, B61403, B61467, B61492, B61519, B71574, B71609, B71650, B71683, B71747, B71752, B71779, B71782, B81959, R009, R010, R106, R118, R123, R128, R145 FC-38LP A01033, A01067, A01068, A01078, A01094, A01109, A01125, A01127, A01129, A01140, A01141, A01143, A01149, A01151, A01152, A01179, A01221, A01248 FC-38LV A01002, A01003, A01025, A01026, A01033, A01037, A01088, A01109, A01114, A01116, A01143, A01147, A01148, A01157, A01159, A01166, A01191, A110341, A110343, A11196, A11210, A11211, A11212, A11213, A11223, A11238, A11257, A11268R, A11290, A11313, A11336 FC-38LX A13112, A81003, A81012, A81017, A81024, A81026, A81028, A81034, A81037, A81038, A81050, A81059, A81065, A81068, A81071, A81075, A81078, A81090, A81093, A81103, A81110, A81111, A81114, A81122, A81132, B02419, B02426, B91150, B91151, B91157, B91180, B91187, B91188, B91195, B91203, B92215, B92243, B92254, B92257, B92262, B92265, B92284, B92285, C021019, C021021, C021023, C02476, C02495, C02517, C02520, C02535, C02544, C02545, C02557, C02565, C02572, C02587, C02590, C02623, C02631, C02634, C02637, C02648, C02664, C02665, C02669, C02672, C02704, C02735, C02756, C02758, C02762, C02763, C02764, C02771, C02784, C02824, C02857, C02860, C02867, C02889, C02901, C02905, C02966, C02973, C02984, LX1001, LX1002, LX1003, P98003, P99005 FC-38MX C02417, C02420, C02426, C02427, C02428 FC-38SH A41003, A51013, A51014, A61079, A71095, A71108, A71110, A81154, A81158, A81161 FC-38SX2 A81014, A81019, B02066, B02071, B02074, B02086, B92059, C02108, C02125 FC-38TLH A01050, A71001 FC-P34 R031 FC-PP34L A01001. RECALLING FIRM/MANUFACTURER Recalling Firm: Pentax Precision Instrument Corp. (PPIC), Orangeburg, NY, by letters on October 24, 2001. Manufacturer: Asahi Optical Co., Ltd. (AOC) Tokyo, Japan. FDA initiated recall is ongoing. REASON Angle Wire Connecting Receptacle component was observed to be cracking, resulting in a loss of angulation control for the direction in which the part was applied (up, down). VOLUME OF PRODUCT IN COMMERCE 3630 units. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Small power chairs and TurnAbout power chairs (510(k) # 972370). Recall # Z-0700-2/Z-0701-2. The small power chairs include the following product names: Chauffeur Littlest Viva, Chauffeur Littlest Viva Plus, Rascal Model 250, Rascal Model 255, Rascal Model 410, Rascal Model 415, Chauffeur Model 250 and Chauffeur Model 255. The TurnAbout power chairs include the following product names: TurnAbout and TurnAbout Heavy Duty. These power chairs are personal motorized vehicles intended to provide mobility for individuals, such as the handicapped and the elderly, who are limited in movement. The power chairs are shipped either covered in plastic or in a brown cardboard unit container labeled with “***MADE WITH PRIDE IN THE U.S.A. ***ELECTRIC MOBILITY***”. The products are labeled with stick-on labels. Labeling information follows. 1. Chauffeur Littlest Viva models are labeled as: a) “LITTLEST VIVA” in black letters on silver background; and b) “Chauffeur mobility” in silver letters, except for the second “f” which is red, outlined in black on a silver background. The Littlest Viva Plus is also labeled with “plus” in black letters on a silver background. 2. Rascal models are labeled as: a) “ELECTRIC MOBILITY in gold letters; b) “Rascal” in gold letters; and, depending on the model number, c) either “250 PC”, “255 PC”, “4 10 PC”, or “415 PC” in gold letters. 3. Chauffeur models are labeled as: a) “Chauffeur mobility” in silver letters, except for the second “f” which is red, outlined in black on a silver background; and, depending on the model number, b) either “250 PC” or “255 PC” in black on a silver background. 4. TurnAbout models are labeled as: a) “ELECTRIC MOBILITY in gold letters; and b) “TurnAbout***by Rascal” in gold letters. CODE Serial codes from JS001011 to JS010742 Serial numbers JS001011 to JS010742 are affected. These serial numbers were manufactured between March 1, 1999 and September 28, 2001. The serial number is attached to the frame of the power chairs. It is located on the rear of the Rascals and Chauffeur models and near the foot-plates of the TurnAbout models. RECALLING FIRM/MANUFACTURER Electric Mobility Corp., Sewell, NJ, by e-mail, letter and notice on January 7, 2002. Firm initiated recall is ongoing. REASON The wheel bolt can loosen and cause the wheel to separate from chair. VOLUME OF PRODUCT IN COMMERCE 8,293 chairs. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Interlink System Continu-Flo Solution Set, 10 drops/ml. approximately, 110" (2.8m), with 3 injection sites and a male luer lock adapter; product code 2C6537W. Recall # Z-0704-2. CODE All lots of product code 2C6537W. RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corp. Round Lake, IL, by letters on January 25, 2002. Manufacturer: Baxter Healthcare Corp. Singapore, SG. Firm initiated recall is complete. REASON Retrograde flow during direct injection. VOLUME OF PRODUCT IN COMMERCE 368,419 sets. DISTRIBUTION Nationwide. _______________________ PRODUCT Helix Diagnostics, Enzyme Immunoassay Helicobacter pylori H. pylori) IgM Test Kits. Recall # Z-0705-2. CODE Catalog # 96HPM, All lot numbers. RECALLING FIRM/MANUFACTURER Bio-Rad Laboratories, Inc., West Sacramento, CA, by telephone and fax on Jan. 25, 2002. Firm initiated recall is ongoing. REASON Device marketed without a 510(k) or PMA. VOLUME OF PRODUCT IN COMMERCE 284 kits. DISTRIBUTION NJ, TX and CA. _______________________ PRODUCT Haemonetics PCS2 Harness Set, Sterile List Number: 620. Recall # Z-0706-2. CODE PCS2 Harness Set REF: 620 Lot Numbers: 010515530, 010515531, 010516330, 010516532, 010517331, 010518332, 010518333, 010519330, 0105121331,010521332, 010912330, 010913331. RECALLING FIRM/MANUFACTURER Recalling Firm: Haemonetics Corp., Braintree, MA, by letter on January 25, 2002. Firm initiated recall is ongoing. REASON Potenial leakage at needle adapter site may expose user to donor blood. VOLUME OF PRODUCT IN COMMERCE 119,100 units. DISTRIBUTION CA, CO and NM _______________________ PRODUCT FlexiLab Laboratory Information System. Recall # Z-0710-2. CODE Version 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ REASON Date Format Issue--Flexilab Software converts specimen collect and receipt dates to American standard format 'mm/dd/yyyy'. For sites using the Euro date format this can alter the generation of QA warnings or flags based on collect or receipt date. VOLUME OF PRODUCT IN COMMERCE 264. DISTRIBUTION Nationwide and the United Kingdom, Ireland, Canada, Denmark, Bermuda and Saudi Arabia. _______________________ PRODUCT On-Site Alcohol test kit. Recall # Z-0711-2. CODE All lots of Catalog # 47464. Lots: 0110201, 0110202, 0110203, 0110204, 0110205, 0110208, 0110304, 0110305, 0110306, 0110307, 0110308, 0110309, 0110310, 0110311, 0110401, 0110402, 0110404, 0110502, 0110503, 0110504, 0110506, 0110507, 0110508, 0110601, 0110604, 0110605, 0110607, 0110608, 0110701, 0110703, 0110704, 0110705, 0110707, 0110805, 0110806, 0110807, 0110902, 0110904, 0110906, 0110907, 0110908, 0111001, 0111003, 0111006, 0111008, 0111102, 0111103, 0111104, 0111107, 0111201, 0111202, 0111203, 0111204 and 0111205. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by notice dated February 15, 2002. Manufacturer: ANSYS Technologies Inc., Lake Forest, CA. Firm initiated recall is ongoing. REASON False negative results or false positive may be reported. VOLUME OF PRODUCT IN COMMERCE Approx. 10,000 kits. DISTRIBUTION Nationwide. _______________________ PRODUCT PORT-A-CATH II Dual-Lumen Low Profile Polysulfone/Titanium (Implantable) Venous Access System, with 1.0mm I.D PolyFlow Polyurethane Catheter and 7 French Introducer Set. Recall # Z-0712-2/0713-2. CODE Reorder Number 21-8065-24, Lot Number 75702 Reorder Number 21-8066-24, Lot Numbers 75703 and 75467. RECALLING FIRM/MANUFACTURER Sims Deltec, Inc. St. Paul, MN, by notification dated Feb. 6, 2002. Firm initiated recall is ongoing. REASON The Wing-Lock catheter connectors of some of the devices will not snap into place as described in the Instructions for Use. VOLUME OF PRODUCT IN COMMERCE 74 devices. DISTRIBUTION CA, FL, MI, NY, SC, TX and Italy and Switzerland. _______________________ PRODUCT AngioJet Drive Units (product number 101973-TAB) for the AngioJet Rheolytic Thrombectomy System (AngioJet System), Recall # Z-0714-2. CODE Drive Unit serial numbers 11881, 11882, 11883, 11887, 11888, 11889, 11898, 11899, 11900, 11901, 11902, 11903, 11907, 11908, 11909, 11910, 11911, 11912, 11913, 11914, 11915, 11916, 11917, 11918, 11919, 11920, 11921, 11922, 11924, 11925, 11929, 11930, 11932, 11937, 11938, 11939, 11941, 11942, 11948, 11950, 11951, 11952, 11953, 11955, and 11958. RECALLING FIRM/MANUFACTURER Possis Medical, Inc., Minneapolis, MN, by letter dated February 8, 2002. Firm initiated recall is ongoing. REASON Loose hardware can fall on the circuit board producing an intermittent or permanent electrical failure of the Drive Unit. VOLUME OF PRODUCT IN COMMERCE 45 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Comp-Air Elite Rechargeable Battery and DC Auto Adapter for NE-C21 Comp- Air Elite Compressor, Model C21BATKIT; Made in Italy. Recall # Z-0715-2. CODE Catalog #C21BATKIT, lots 00X and 00Y. RECALLING FIRM/MANUFACTURER Recalling Firm: Omron Healthcare, Inc. Vernon Hills, IL, by letter dated February 7, 2002. Manufacturer: Medel Italiana Srl Polo di Torrile, Italy. Firm initiated recall is ongoing. REASON Premature failure of rechargeable battery. VOLUME OF PRODUCT IN COMMERCE 3000 batteries. DISTRIBUTION Nationwide. _______________________ PRODUCT 1) Merit Manifolds 2) Merit Coronary Control Syringes 3) Merit Fluid Administration Sets 4) Merit Custom Convenience Sets 5) Merit Contrast Management System 6) Merit Disposal Depot 7) Merit Pressure Monitoring Tubing 8) Merit VacLok Syringes. Recall # Z-0716-2/Z-0723-2. CODE Manifolds: Part Number Lot Number 203BF-R A197475, A200008, A201610 203HF-F A197472 203HF-R A199074 203HN-R A197468, A199073, A200709, A204267 204BF-FT A200707 204BN-R A197467 204HN-R A197465 205BF-F A197464 503BF-R A195336, A197454, A199071 503HF-R A197450, A198412 503HN-R A197448, A200692 504BN-R A203641 504HN-R A201604 Control Syringes: Part Number Lot Number CCS100E/B A197836, A198569, A202912 CCS101E/B A200938, A203843 CCS200E/B A199196, A199849 CCS201E/B A201571 CCS320E/B A201573, A202055, A203848 CCS600E/B A204443 CCS880 A198081, A199260, A201728, A203046 CCS881 A198012, A198563, A199259, A201729, A205109 CCS900E/B A202061 CCS901E/B A199203, A202919 CCSB900E/B A200946, A204449 CCSB901E/B A197126, A204377 CCSB910E/B A200948 CCSB911E/B A199860, A202066 Fluid Administration Sets: Part Number Lot Number FAS1072 A202694 FAS1108 A199659 FAS1272 A202690 FAS5072 A199661 FAS5108 A201100 FAS6072 A199662 Custom Kits: Part Number Lot Number K02-00112 A203976 K02-00204B A200254 K02-00342 A203986 K02-00377B A200256 K02-00425A A203989 K02-00493 A200908 K02-00519 A203995 K02-00565A A203997 K02-00660 A202235 K02-00665 A200262 K02-00666 A200263 K02-00672 A202025 K02-MS2367B A201699 K02-MS2467A A201714 K04-00476 A202346 K07-00081B A200250 K08-00078A A203531 K08-00417B A204101 K08-00572 A201874 K08-00575 A204180 K08-00669 A201670 K08-00674 A199131, A201143 K08-00807 A201775 K08-00892 A198806 K08=01075 A202926 K08-01164 A200980 K08-01189 A204106 K08-01196 A203418 K08-01254 A203628 K08-01257 A197768 K08-01264 A201170 K08-01341A A199520 K08-01357A A199517 K08-MP5100F A203052 K08-MP5128A A198620 K09-00317H A197932 K09-00378J A198421, A202152 K09-00378K A202929 K09-00386M A197564, A201206 K09-00526D A200744 K09-00590G A199701 K09-00611H A200745, A203185 K09-00848L A199133 K09-01002H A202934 K09-01056D A198873 K09-01803F A197775, A202941 K09-01975H A200028, A203438 K09-02112C A198886 K09-02130M A199141, A200791 K09-02277B A205024 K09-02353B A199144, A203479 K09-02489M A196525 K09-02571F A202581 K09-02900C A197710, A204601 K09-02988C A204103 K09-03013 A204035 K09-03242 A201297 K09-03634D A203497 K09-03671J A200033 K09-03696J A203500 K09-03743 A204625 K09-03764F A200034 K09-03829H A200037 K09-04020 A199747 K09-04098C A203668 K09-04297F A201907 K09-04316B A199160, A201908 K09-04696D A203678 K09-04904G A195924, A201843 K09-04923A A200356 K09-04962 A201915 K09-05015A A197680 K09-05043A A201916 K09-05069B A199168 K09-05289 A199169 K09-05297 A205038 K09-05458 A204431 K09-05522 A201848 K09-05582 A203857 K09-05664 A201921 K09-05709 A196570, A200982 K09-05717 A203866 K09-05735B A205672 K09-05759A A197591 K09-05759B A204663 K09-05824 A202158 K09-05839 A203743 K09-05859 A201651 K09-05891 A201646 K09-05895 A202593 K09-05939A A202899 K09-05948 A201205 K09-05949 A200979 K09-05966 A200533 K09-06143 A205663 K09-90075M A203872 K09-90091D A199172 K09-90496G A203885 K09-KH001 A200136 K09-MM2000D A201784, A202395 K09-MM2114C A201785 K09-MM2134A A203419 K09-MM2193 A203887 K09-MM2237 A202636 K09-MM2289 A202900 K09-MM2290A A204423 K09-MS2020C A203891 K09-MS2050J A199177, A200532, A202398 K09-MS2061D A202654, A204724 K09-MS2082C A204839 K09-MS2105C A203896 K09-MS2124C A204672 K09-MS2137B A203898 K09-MS2139 A203899 K09-MS2146C A203900 K09-MS2152B A203901 K09-MS2155B A203902 K09-MS2179 A203083 K09-MS2186B A203086 K09-MS2187B A201424 K09-MS2192A A203905 K09-MS2201C A204674 K09-MS2211 A203087 K09-MS2223A A200176 K09-MS2239B A203909 K09-MS2252 A203911 K09-MS2286B A199758, A204676 K09-MS2301 A201794 K09-MS2352 A203555 K09-MS2393 A203916 K09-MS2409 A203089 K09-MS2415 A204679 K09-MS2423 A203917 K09-MS2426 A201438, A203557 K09-MS2427A A202403, A203918 K09-MS2480C A202404 K09-MS2531 A203922 K09-MS2550 A203924 K09-MS2584 A203560 K09-MS2594 A199843, A202807 K09-MS2602 A204424 K09-MS2606 A205674 K09-MS2608 A204104 K09-MS2619 A204425 K09-MST2000E A203090 K09-MST2040 A203092 K09-MST2041C A203926 K09-MST2054C A203093 K09-YSI029 A201801 K10-00076F A206478 K10-00127L A199567, A202577 K10-00149H A200462, A201781 K10-00227K A203935 K10-00389H A203941 K10-00414B A203942 K10-00445 A203943 K10-00630F A200441 K10-00731J A200439 K10-00778 A201121 K10-00785J A197634, A199354, A203155 K10-00869H A200437 K10-01078A A196646 K10-01152F A198408 K10-01231 A204363 K10-01236 A204362 K10-01245F A200423 K10-01305 A200837 K10-01402 A199097, A202638 K10-01440 A204354 K10-01613A A204346 K10-01658 A199404, A201488 K10-01721A A201547 K10-01740 A201490 K10-01750 A204338 K10-01758 A196664 K10-01816 A201546 K10-01887 A198517 K10-01901 A205175 K10-01914 A200166 K10-01925 A199839 K10-01967 A200543 K11-00096 A200384 K11-00099 A197918 K11-00100 A199398, A200382, A204332 K11-00137 A199397 K11-00144 A201506 K11-00202 A201505 K11-00301 A201503, A203621 K11-00357D A204330 K11-00382B A204327 K11-00392 A202145 K11-00546 A196198 K11-00584 A201500 K11-00588 A197657 K11-00605 A205045 K11-00611 A204105 K11-00630 A202902 K11-00635 A198516 K11-00637 A201763 K12-00040 A204324 K12-00196C A198800 K12-00246B A201870 K12-00263 A199379 K12-00316 A202631 K12-00326 A201871 K12-00391 A203035 K12-00429A A201498, A204322 K12-00530A A201776 K12-00530B A207470 K12-00604 A197928 K12-00643 A201668 K12-00657 A202703 K12-00679 A199782 K12-YP017 A193612 Disposal Depot: Part Number Lot Number MDD200H A199651, A201096, A202680, A202684 MDD220 A204808 MDD220H A202685 MDD600 A199657 Pressure Monitoring Line: Part Number Lot Number PM6048 A203084 PM6112 A203077 PM6136 A203079 Vaclok Syringe Part Number Lot Number VAC120E A204504. RECALLING FIRM/MANUFACTURER Merit Medical Systems, Inc., South Jordan, UT, by a Merit employee beginning November 1, 2001. Firm initiated recall is ongoing. REASON Seals on Tyvek/Nylon pouches are potentially defective. VOLUME OF PRODUCT IN COMMERCE 57,301 units. DISTRIBUTION Nationwide and Brazil, Canada, China, Egypt, England, France, Ireland, Japan, Kuwait, Lebanon, New Zealand, Pakistan and Venezuela. ______________________ PRODUCT Baxter Spinal Anesthesia Trays, product code 1T2356. Recall # Z-0724-2. CODE Product code 1T2356, lot GD734509. RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letter dated February 15, 2002. Manufacturer: Baxter Healthcare Corporation Cleveland, MS. Firm initiated recall is ongoing. REASON Trays labeled with incorrect expiration date. VOLUME OF PRODUCT IN COMMERCE 3,978 trays. DISTRIBUTION Nationwide. _______________________ PRODUCT Nichols Advantage Thyroglobulin Assay An in-vitro diagnostic intended for the quantitative mesurement of Thyroblobulin in human serum. Recall # Z-0725-2. CODE All Lots. RECALLING FIRM/MANUFACTURER Nichols Institute Diagnostics, San Juan Capistrano, CA, by letter dated January 25, 2002. Firm initiated recall is complete. REASON Dilution result may read less than the 0.9 ng/mL negative out-off. VOLUME OF PRODUCT IN COMMERCE 53. DISTRIBUTION Nationwide and Germany, France, Chile, Brazil, Greece, Spain and Portugal. _______________________ PRODUCT Premium Abduction Pillow with Kodel Band; Custom Abductor Pillow; and 6” Patella Strap. Recall # Z-0726-2/0727-2. CODE Premium Abduction Pillow with Kodel Band Model Number, M60- 025-S, codes: 854182, 85861, 856410, 858472, 859513 Premium Abduction Pillow with Kodel Band Model Number, M60- 025-M, codes: 854181, 857959, 858506, 859263, 859515, 860769 Premium Abduction Pillow with Kodel Band Model Number, M60- 075, codes: 849938, 857077 Custom Abductor Pillow Universal Model Number, M60-081, code: 858686 6” Patella Strap Model Number, 6P, code: 860305. RECALLING FIRM/MANUFACTURER Recalling Firm: Deroyal Industries, Inc., Powell, TN, by letter dated January 31, 2002. Manufacturer: Deroyal Orthopedic Fabrication, Maynardville, TN. Firm initiated recall is ongoing. REASON Undeclared natural rubber. VOLUME OF PRODUCT IN COMMERCE 506 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Sysmex Automated Hematology Analyzers and Sysmex Automated Reticulocyte Analyzers. Recall # Z-0731-2/Z-0742-2. Models: a) K-4500, Automated Hematology Analyzer, an in-vitro device for use in clinical laboratories to analyze whole blood samples as a screening device for identifying samples with abnormal cells. b) R-3500, Automated Reticulocyte Analyzer, a fully automated reticulocyte analyzer for in-vitro diagnostic use in clinical laboratories. c) SF-3000, Automated Hematology Analyzer, an in-vitro device for blood cell analysis in clinical laboratories, as a screening device for identifying samples with abnormal cells. Medical Technologists are responsible for final review of abnormal cells. d) SE-9000, Automated Hematology Analyzer, 23 parameters, an in- vitro device for whole blood cell analysis in clinical laboratories, as a screening device to flag specimens containing abnormal blood cells. Medical Technologists are responsible for final review of abnormal cells. e) SE-9500, Automated Hematology Analyzer, 25 parameters, an in- vitro device for whole blood cell analysis in clinical laboratories, as a screening device to flag specimens containing abnormal blood cells. Medical Technologists are responsible for final review of abnormal cells. f) SP-100, Automated Hematology Slide Preparation Unit. g) XE-2100, Automated Hematology Analyzer, 32 parameters, networking capability, intended to classify formed elements in EDTA anti- coagulated blood. h) XE-2100L, Automated Hematology Analyzer, 26 parameters, networking capability, expandable to the XE-2100L Twin System, intended to classify formed elements in EDTA anti-coagulated blood. i) SE-Alpha, Integrated Hematology System, receives the data from the SE-9000/9500 automated hematology analyzer and directs the SP-100 to prepare a blood film and stain on appropriate samples, to perform complete hematology analysis, slide preparation and staining in a walk-away environment. j) SE-HST, Total Hematology Automation System, receives the data from the SE-9000/9500 automated hematology analyzer and the R-3500 automated reticulocyte analyzer, and directs the SP-100 to prepare a blood film and stain on appropriate samples, utilizing the HST conveyor transport system which automates the manual transfer of blood sample racks between devices and to automate manual blood film preparation. k) XE-Alpha, Hematology Alpha Transportation System, receives the data from the XE-2100 automated hematology analyzer and directs the SP- 100 to prepare a blood film and stain on appropriate samples, to perform complete hematology analysis, slide preparation and staining in a walk- away environment. l) XE-HST, Total Hematology Automation System, receives the data from the XE-2100 automated hematology analyzer and the R-3500 automated reticulocyte analyzer, and directs the SP-100 to prepare a blood film and stain on appropriate samples, utilizing the HST conveyor transport system which automates the manual transfer of blood sample racks between devices and to automate manual blood film preparation. CODE Model numbers K-4500, R-3500, SF-3000, SE-9000, SE-9500, SP-100, XE-2100, XE-2100L, SE-Alpha, SE-HST, XE-Alpha, XE-HST; all serial Numbers. RECALLING FIRM/MANUFACTURER Recalling Firm: Sysmex Corporation of America, Long Grove, IL, by e-mail on October 16, 2001 and user notifications on January 4 and February 11, 2002. Manufacturer: Sysmex Corporation Kobe, Japan. Firm initiated recall is ongoing. REASON Potential misidentification of samples. VOLUME OF PRODUCT IN COMMERCE 1,092 systems. DISTRIBUTION Nationwide. _______________________ PRODUCT Boston Scientific Medi-Tech Imager II 4 Fr Angiographic Catheters in the types and models described below: Product Description Catalog Numbers a) 4F/Tennis Racquet .035”/65 cm M001315001 b) 4F Tennis Racquet .035”/90 cm M001315011 c) 4F Pigtail .035”/65 cm M001315091 d) 4F Straight .035”/65 cm M001315101 e) 4F Pigtail .035”/90 cm M001315111 f) 4F Straight .035”/90 cm M001315121 g) 4F Contra .035”/65 cm M001315251 h) 4F Contra .035”/90 cm M001315261 i) 4F Contra .035”/100 cm M001315271 Recall # Z-0743-2/0751-2. CODE By product descriptions below, the lot numbers are listed: a) lot numbers FA12902, FA13151, and FA14089; b) lot numbers 5671, FA13152, FA14220, and FA13921; c) lot numbers FA13156 and FA14088; d) lot numbers 5674, FA12802, FA13127, FA13511, and FA14090; e) lot numbers 5675, FA13922, and FA13157; f) lot numbers FA12907, 5676, FA12804, FA13513, FA13514, FA13615, and FA13616; g) lot numbers FA13130, FA13619, FA13620, 5677, and FA12805; h) lot numbers 5678, FA12806, FA12908, FA13797, FA13798, and FA14724; h) lot numbers FA12807, FA13795, and FA13796. RECALLING FIRM/MANUFACTURER Recalling Firm: Boston Scientific Scimed, Inc., Maple Grove, MN., by letter dated February 11, 2002. Manufacturer: TFX Medical Annacotty, Co., Liomerick, Firm initiated recall ongoing. REASON Catheter tip may separate from the device if significant flexing forces are applied. VOLUME OF PRODUCT IN COMMERCE 752 boxes (5 catheters per box). DISTRIBUTION Nationwide and the Netherlands. _______________________ PRODUCT Becton Dickinson's ColorPAC brand Giardia/Cryptosporidium Rapid Assay in-vitro diagnostic kit, packaged in papercard box, each kit containing instructions, reagents and components to perform 30 tests. Recall # Z-0756-2. CODE Lot 219370 exp June 5, 2002. RECALLING FIRM/MANUFACTURER Recalling Firm: Becton Dickinson Microbiology Systems Sparks, MD, by letter, fax and e-mail on February 21, 2002. Manufacturer: Genzyme Corp., Cambridge, MA. Firm initiated recall is ongoing. REASON IVD kit may exhibit false positive results. VOLUME OF PRODUCT IN COMMERCE 695 kits. DISTRIBUTION Nationwide and Australia, Canada and Shanghai. _______________________ PRODUCT Kendall Mahurkar 12Fr Triple Lumen Catheter Kits and Trays. Recall # B- 0757-2/B-07561-2. CODE Description Lot Number 8888101002 Mahurkar 12Fr Triple Lumen Catheter Tray 120883 16 cm 8888101002 Mahurkar 12Fr Triple Lumen Catheter Tray 121590 16 cm 8888101003 Mahurkar 12Fr Triple Lumen Catheter Tray 121118 20 cm 8888101003 Mahurkar 12Fr Triple Lumen Catheter Tray 121934 20 cm 8888102003 Mahurkar 12Fr Triple Lumen Catheter Tray 122470 w/str Ext 20 cm 8888345611 Mahurkar 12Fr Triple Lumen Catheter Kit 120506 16 cm International Only: 8888345611 Mahurkar 12Fr Triple Lumen Catheter Kit 121427 16 cm 8888345611 Mahurkar 12Fr Triple Lumen Catheter Kit 121805 16 cm 8888345629 Mahurkar 12Fr Triple Lumen Catheter Kit 120878 20 cm RECALLING FIRM/MANUFACTURER Recalling Firm: Tyco Healthcare/ Kendall Mansfield, MA, by letter dated December 14, 2001. Manufacturer: The Kendall Co. lp, Argyle, NY. Firm initiated recall is ongoing. REASON Dialysis catheter connection may crack and cause leakage of fluid. VOLUME OF PRODUCT IN COMMERCE 1595 units. DISTRIBUTION Nationwide and Belgium and Canada. _______________________ PRODUCT Mammary sizer; intraoperative determination for volume of breast implants. Recall # Z-0764-2/Z-0765-2. CODE MSA300 Lot# 1M217 (5 units) MSR450 Lot# 1M213 (1 unit). RECALLING FIRM/MANUFACTURER Specialty Surgical Products, Inc., Victor, MT, by telephone and fax on December 20, 2001. Firm initiated recall is complete. REASON Product mislabeled as sterile when it was non-sterile. VOLUME OF PRODUCT IN COMMERCE 6. DISTRIBUTION PA, FL and NY. _______________________ PRODUCT Roche/Hitachi Tina-quant IgM. , Recall # Z-0768-2. CODE Catalog # 1929305. Lots 61361701, 61947001, 62245301, 62246301 and 62377001. Exp. 2/28/2002, 6/30/2002, 12/31/2002, 8/31/2002 and 2/28/2003 respectively. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated February 26, 2002. Manufacturer: Roche Diagnostics, Mannheim, Germany. Firm initiated recall is ongoing. REASON Precipitate in r2 bottle causes false high or low results. VOLUME OF PRODUCT IN COMMERCE 870 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Sysmex Automated Hematology Analyzers. Models: a) XE-2100, Automated Hematology Analyzer, 32 parameters, networking capability, catalog #983-1341-1. Recall # Z-0774-2; b) XE-2100L, Automated Hematology Analyzer, 26 parameters, networking capability, expandable to the XE-2100L Twin System, catalog #993-3731-9 (L). Recall # Z-0775-2. CODE All serial numbers of models XE-2100 and XE-2100L. RECALLING FIRM/MANUFACTURER Recalling Firm: Sysmex Corporation of America, Long Grove, IL, by "End User Bulletin" on January 18 and March 19, 2002. Firm initiated recall is ongoing. REASON Potential misidentification of samples due to a time out error. VOLUME OF PRODUCT IN COMMERCE 132 units. DISTRIBUTION Nationwide and Puerto Rico. _______________________ PRODUCT Sysmex Automated Hematology Analyzers. Models: a) XE-2100, Automated Hematology Analyzer, 32 parameters, networking capability, catalog #983-1341-1. Recall # Z-0776-2; b) XE-2100L, Automated Hematology Analyzer, 26 parameters, networking capability, expandable to the XE-2100L Twin System, catalog #993-3731-9 (L). Recall # Z-0777-2. CODE Models XE-2001 and XE-2100L, all serial numbers. RECALLING FIRM/MANUFACTURER Recalling Firm: Sysmex Corporation of America, Long Grove, IL, by e-mail to Roche on January 18 and "End User Bulletin" on March 19, 2002. Firm initiated recall is ongoing. REASON Potential misidentification of samples. VOLUME OF PRODUCT IN COMMERCE 132 units. DISTRIBUTION Nationwide and Puerto Rico. _______________________ PRODUCT Aspiration tube of I/A stainless steel handpieces part number 10- 030. I/A handpieces are used in cataract surgery to aspirate and irrigate the lens cavity. Recall # Z-0778-2/Z-0780-2. CODE I/A Handpiece P/Ns: IH-90200, SI-98200 and MH311; Lot #'s 012096, 012772, 012989, 013036, 013470, 013624, 013726, 013803, 014354, 014363, 014392, 014413, 014437, 014438, 014462, 014467, 014471, 014478 Aspiration slug P/N: 10-030. RECALLING FIRM/MANUFACTURER Microsurgical Technology, Inc., Redmond, WA, by telephone on May 8 and letters on June 5, 2001. Firm initiated recall is complete. REASON Leaking aspiration tubes. VOLUME OF PRODUCT IN COMMERCE 282 handpieces. DISTRIBUTION CA, ID, FL, MO, PA, TN and UT.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________ PRODUCT Vitros Digoxin Slides, for use with Vitros Chemistry Systems to quantitatively measure Digoxin concentration in serum and plasma. Recall # Z-0025-2. CODE 1921-0074-0782 RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, INC. Rochester, NY, by telephone on July 5, 2001. Firm initiated recall complete. REASON Analyzer could produce biased results due to incorrect lot # on barcode. VOLUME OF PRODUCT IN COMMERCE 168 cartridges/18 slides per cartridge. DISTRIBUTION FL, IL, and NY _______________________ PRODUCT All DataCare Systems Software, as follows: a) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9200 b) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9201 c) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog BP9251 d) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog BP9252 e) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog; GD9200 f) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9201 g) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog; GD9206 h) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog; GD9207 i) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog; GD9208 j) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog; BP9251 k) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog; BP9252 l) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9202 m) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9209 n) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9010 o) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9211 p) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9212 q) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog BP9215 r) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog BP9216. Recall # Z-0682-2/Z-0699-2. CODE All units. RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN, by correction notice dated November 13, 2001. Firm initiated recall is ongoing. REASON Potential patient/sample mismatch. VOLUME OF PRODUCT IN COMMERCE Approx. 450 installations. DISTRIBUTION Nationwide, Canada and the United Kingdom. _______________________ PRODUCT DynaTorq brand Dental Torque Wrench. Recall # Z-0752-2/Z-0754-2. CODE Model/Lots: DTW4321 (lots 33670, 33586, 33496) DTW4331 (lots 33491, 33611, 33495) GTW4331 (lots 33671, 33658). RECALLING FIRM/MANUFACTURER Micro Motors, Inc. Santa Ana, CA, by telephone and letter on February 28, 2002. Firm initiated recall is ongoing. REASON Error in torque setting. VOLUME OF PRODUCT IN COMMERCE 205. DISTRIBUTION CA. _______________________ PRODUCT Hill-Rom Utility Shelf for placement of equipment on the Uniflex headwall. Model P105001. Recall # Z-0762-2. CODE All model P105001 utility shelves distributed between February 1996 and April 2001. RECALLING FIRM/MANUFACTURER Hill-Rom Co. Inc., Batesville, IN, by lettter on or about February 7, 2002. Firm initiated recall is complete. REASON Electrical shock hazard. VOLUME OF PRODUCT IN COMMERCE 1,372. DISTRIBUTION Nationwide, Canada, Great Britain, Jordan, Lebanon, Mexico, Taiwan and Turkey _______________________ PRODUCT Boston Scientific/Medi-Tech: Vaxcel PICC Peripherally Inserted Central Catheter 6 Fr Dual Lumen Clampable Hub, 130 cm Wire Catalog Number: 45-426. Recall # Z-0763-2. CODE Lot Numbers: 109282, 111270. RECALLING FIRM/MANUFACTURER Recalling Firm: Medi-Tech a division of Boston Scientific Corp., Watertown, MA, by letter on January 16 and 24, 2002. Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc., Sandy, UT. Firm initiated recall is ongoing. REASON Outer Carton is mislabeled as 6 Fr Dual Lumen, inner label correctly identifies product as a 5 Fr Single Lumen. VOLUME OF PRODUCT IN COMMERCE 1914. DISTRIBUTION Nationwide. _______________________ PRODUCT Aspiration Slug in the Phaco handpieces - Phaco handpieces are AC-powered devices with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the contaract. Recall # Z-0766-2/0767-2. CODE Phaco handpiece P/N PH-10441and PH-10140 Aspiration slug P/N 40-030, Lot #104244. RECALLING FIRM/MANUFACTURER Microsurgical Technology, Inc., Redmond, WA, by telephone on April 25, 2001. Firm initiated recall is complete. REASON Burr in aspirator pathway. VOLUME OF PRODUCT IN COMMERCE 61 handpieces. DISTRIBUTION CA, CO and KY and Italy and Hong Kong. _______________________ PRODUCT a) Cook Check-Flo Plus Introducer Set, 12 French. Recall # Z-0771-2; b) Cook Check-Flo Plus Introducer Set, 14 French. Recall # Z-0772-2; c) Cook Check-Flo Plus Introducer Set, 16 French. Recall # Z-0773-2. CODE All of these sets containing catalog number prefixes VCF, VCFW, RCF, RCFW and RCFN are being recalled. RECALLING FIRM/MANUFACTURER Cook, Inc., Bloomington, IN, by letter dated November 27, 2001. Firm initiated recall is ongoing. REASON Valve may move into patient through introducer. VOLUME OF PRODUCT IN COMMERCE 7,348. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS III
_______________________ PRODUCT a) Pen Pals Pullet Starter-Grower 70009ACF Medicated, a Complete Feed for Starting and Growing Chickens, containing amprolium 0.0125% and bacitracin methylene disalicylate 25 gm/ton, packaged in 50-lb. bags. Recall # V-031-2. b) Pen Pals Meat Maker 70012ACF Medicated, a complete feed for finishing broilers, containing amprolium 0.0125% and bacitracin methylene disalicylate 25 gm/ton, packaged in 50- lb. bags. Recall # V-032-2. The responsible firm on both product labels shows the products are manufactured by Consolidated Nutrition, L.C., Omaha, NE. CODE a) Pen Pals Starter/Grower, Formula No. 70009ACF b) Pen Pals Meat Maker, Formula No. 70012ACF. RECALLING FIRM/MANUFACTURER ADM Alliance Nutrition, Inc., Washington, IA, by telephone on December 17, 2001. FDA initiated recall is complete. REASON Medicated feed manufactured with an expired Type A, Category II, drug. VOLUME OF PRODUCT IN COMMERCE 24/50 lb. bags of Product No. 70009ACF; 16/50 lb. bags of Product No. 70012ACF. DISTRIBUTION IA.END OF ENFORCEMENT REPORT FOR APRIL 10, 2002 ####
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