August 8, 2001 01-31RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-467-1, Sci-Fit Tri-Cuts Dietary Supplement Capsules sold in 90 and 180 count bottles. The product contains 1000 mcg of tiratricol (100 mg of Tricol). The product is sold 12 bottles per case. The product label states “Formulated and Distributed by: Sci-Fit, 140 Pennsylvania Avenue, Oakmont, PA”. The firm recalled all codes of the product on the market at the time the recall was initiated. REASON: The product contained tiratricol (also known as triiodothyroacetic acid or TRIAC), an active thyroid hormone. The product’s label recommends to not exceed three capsules daily. This dose is in excess of the usual replacement dose of thyroid hormone and therefore would cause hyperthyroidism. Particularly in patients with underlying cardiac disease, this poses a significant health risk because of immediate, life-threatening consequences as heart attack, stroke, heart failure and arrhythmia. MANUFACTURER: Synergy Nutritional Industries, Inc., (also known as Trent Pharmaceuticals), Fort Walton Beach, FL RECALLED BY: On 9/12/00, ATF Fitness Products Inc., Oakmont, PA, mailed recall letters to their direct accounts via first class mail. FIRM INITIATED RECALL: Completed DISTRIBUTION: Nationwide QUANTITY: 10,035 90-ct. bottles and 418 180-ct. bottles.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-462-1, Dutch Apple Pie, 9 inch, in plastic clam shell, affixed label stating in part "Flaherty's DUTCH APPLE PIE NET WT. 41 oz. *** Flaherty's 17611 - 128th PLACE NE/WOODINVILLE, WA 98072***". CODE: "03" and "05" REASON: The product contained undeclared whey. MANUFACTURER/RECALLING FIRM: Hi Q Bakery, Inc., Woodinville, WA RECALLED BY: On 7/3/01, the recalling firm visited each location and corrected the products’ labels. FIRM INITIATED RECALL: Complete DISTRIBUTION: Western Washington state and Portland QUANTITY: 189 pies _______________________________ RECALL NUMBER, PRODUCT AND CODE: A) F-447-1, Rosewood brand Chinese Spice Tofu Cubes in 7-ounce vacuum-sealed plastic bags. B) F-448-1, Rosewood brand Italian Garlic Tofu Cubes in 7-ounce vacuum-sealed plastic bags. C) F-449-1, Rosewood brand No Chicken Tofu in 4-ounce vacuum-sealed plastic bags. CODE: Sell by date of 07/31/01 and prior. REASON: The products contained undeclared wheat. MANUFACTURER/RECALLING FIRM: Tofu International, Ltd., Ann Arbor, MI RECALLED BY: On 6/19/01, the firm’s representatives began visiting accounts that had received the products and replaced the customer’s existing stock with the firm’s stock that had new labels on them. FIRM INITIATED RECALL: Completed DISTRIBUTION: Southeast MI QUANTITY: Approximately 235 packages of Chinese Spice Tofu Cubes, 220 packages of Italian Garlic Tofu cubes, and 683 packages of No Chicken Tofu _______________________________ RECALL NUMBER, PRODUCT AND CODE: Waffles in three varieties: F-450-1 Homestyle Waffles (may be labeled as "Homestyle", "Old Fashioned Round" or as "Waffles" - no variety) F-451-1 Buttermilk Waffles F-452-1 Blueberry Waffles The waffles are under 8 brand names: Stater, Roundy's, Sugerencia, Food Club, Spartan, DeMoulas, Super G, and Stop and Shop. The waffles come in either an 8 count, 10 count, 12 count, or 16 count package. All lots distributed prior to June 1, 2001, were subject to recall. REASON: The products contained undeclared FD&C Yellow No. 5 and FD&C Yellow No. 6. MANUFACTURER/RECALLING FIRM: Lakeshore Frozen Foods Inc., Lake City, PA RECALLED BY: The recalling firm faxed a recall letter to their brokers on 6/1/01. FIRM INITIATED RECALL: Completed DISTRIBUTION: CA, IL, IN, MA, MD, MI, OH, TX, VT, and WI. QUANTITY: 136377 cases/6 units per case ______________________________ RECALL NUMBER, PRODUCT AND CODE: F-458-1, Hartville Kitchen brand Blue Cheese Dressing, packaged in 14 oz jars, 1-gallon (128 oz) jugs, and 1.5 oz packets. The firm listed on the label is Hartville Kitchens, Hartville, Ohio. The firm recalled all “Sell-By Dates” from JUN 27 2001 through JAN 1 2002. REASON: The product contained undeclared soy ingredients. MANUFACTURER/RECALLING FIRM: Hartville Kitchen Salad Dressing, Hartville, OH RECALLED BY: The firm telephoned the consignee(s) by telephone on 6/8/2001, followed by letter on 6/9/2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY: 14 oz - 5,610 cases (6 jars per case); 1-gallon - 140 cases (4 jugs per case); 1.5 oz packets- 193 cases (60 packets per case) _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-459-1, Shernoff's Egg Potato Salad, 10 lb. plastic containers coded with “Use by dates” 4/27/01, 5/3/01, 5/10/01, and 5/17/01 REASON: The product contained undeclared FD&C Yellow No. 5 and FD&C Blue No. 1. MANUFACTURER/RECALLING FIRM: Shernoff's Salads, Philadelphia, PA RECALLED BY: The recalling firm telephoned their accounts to notify them of the recall on 4/20/01. FIRM INITIATED RECALL: Completed DISTRIBUTION: PA and NJ QUANTITY: 6000 lbsRECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: The following ice cream brand names and varieties are subject to recall: 1) F-453-1, Buehlers Cookies 'N Cream; 2) F-454-1, Fishers Cookies ' N Cream; 3) F-455-1, Valley Rich Cookies 'N Cream; 4) F-456-1, Valley Rich Blueberry Cobbler; 5) F-457-1, Valley Rich Chocolate Caramel Cashew. CODE: All codes of the referenced products manufactured from June 27,2000 through January 10, 2001, are subject to recall. A black and white label on the bottom of the 1/2 gallon plastic containers lists the Julian date of manufacture. REASON: The products bore incomplete ingredients statements. MANUFACTURER/RECALLING FIRM: Superior Dairy, Inc., Canton, OH RECALLED BY: The firm contacted their affected consignees by telephone on 1/11/2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH and VA QUANTITY: A total of 35,105 one-half gallon containers as follows: Buehlers-8675; Fishers- 1840; Valley Rich Cookies-4120; Valley Rich Blueberry Cobbler-4275; and Valley Rich Choc Carmel Cashew-6195. _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-460-1 Shredded Swiss Cheese F-461-1 Shredded Cheddar Cheese Each type of cheese is sold as a 5 lb unit in a plastic bag. The Swiss cheese is shipped as 6 units per cardboard box and the cheddar cheese is shipped as 4 units per cardboard box. CODE: Expiration date AUG 14 REASON: The products were contaminated with mold. MANUFACTURER/RECALLING FIRM: Laubscher Cheese Company, Inc., Mercer, PA RECALLED BY: The firm notified their accounts by telephone on 6/7/01, followed by visit. FIRM INITIATED RECALL: Complete DISTRIBUTION: NH, MA, OH QUANTITY: 10610 poundsRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1650-1, Corneas for Transplant, Tissue numbers 01-0148 OD and 01-0148 OS REASON: Corneas, collected from a donor whose serum tested positive for anti-HCV, and RIBA positive, were distributed. MANUFACTURER/RECALLING FIRM: Northwest Lions Eye Bank, Seattle, WA RECALLED BY: The recalling firm notified consignees, located in Connecticut and Germany, by telephone, facsimile and e-mail on February 12, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: CT and Germany QUANTITY: 2 unitsRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1633-1, Red Blood Cells, unit number 2822185 REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Central California Blood Center, Fresno, CA RECALLED BY: The recalling firm notified the consignee, located in California, of the RECALLED BY letter dated August 9, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1634-1, Red Blood Cells (4 units), unit numbers 2862592, 2858158, 2853843, 2849093 REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: Central California Blood Center, Fresno, CA RECALLED BY: The recalling firm notified the consignee, located in California, of the RECALLED BY letter dated September 20, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 4 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1635-1, Red Blood Cells, unit number GQ07568 REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Blood Centers of the Pacific, Irwin Center, San Francisco, CA RECALLED BY: The recalling firm notified the consignee, located in California, of the RECALLED BY telephone on November 13, 1997. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1566-1, Platelets Pheresis, Leukocytes Reduced (3 units), unit numbers 90- 45459, 90-45777, and 90-49037 REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: Medic, Inc., Knoxville, TN RECALLED BY: The recalling firm notified consignees, located in Tennessee, of the RECALLED BY letter dated June 2, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TN QUANTITY: 3 unitsRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1637-1, Red Blood Cells, Leukocytes Reduced (8 units), unit numbers 91-90458, 91-90454, 91-90457, 91-90467, 91-90453, 90-57179, 91-90461, and 91-90450 REASON: Blood products that were out of controlled storage for more than 30 minutes were distributed. MANUFACTURER/RECALLING FIRM: Medic, Inc., Knoxville, TN RECALLED BY: The recalling firm notified consignees, located in Tennessee, of the RECALLED BY telephone on October 10, 2000, by letter dated October 11, 2000. FIRM INITIATED RECALL: complete DISTRIBUTION: TN QUANTITY: 8 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1638-1, Red Blood Cells, Leukocytes Reduced (8 units), unit numbers 93-89662, 93-89664, 93-89668, 93-89669, 93-89670, 93-89663, 93-89665, and 93-89667 REASON: Blood products that were out of controlled storage for more than 30 minutes were distributed. MANUFACTURER/RECALLING FIRM: Medic, Inc., Knoxville, TN RECALLED BY: The recalling firm notified consignees, located in Tennessee, of the RECALLED BY letter dated October 23, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TN QUANTITY: 8 units ______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1639-1, Red Blood Cells, Leukocytes Reduced, Irradiated, unit numbers 93-87749 and 93-87780 REASON: Blood products that were out of controlled storage for more than 30 minutes were distributed. MANUFACTURER/RECALLING FIRM: Medic, Inc., Knoxville, TN RECALLED BY: The recalling firm notified the consignee, located in Tennessee, of the RECALLED BY letter dated October 11, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TN QUANTITY: 2 unitsRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0688-1, VARIOUS CUSTOM SURGICAL PROCEDURE TRAYS-see specific listing under "codes" below. These are all Maxxim kits that contain Clinipad Products implicated as Class I although the specific lot number included in the kits cannot be determined until they are opened. KIT ITEM # TRAY NAME CLINIPAD ITEM # 82-6616 CRANIAL ACCESS KIT, W/O DRUGS 3943S-B BMH10BW ARTERIAL LINE TRAY 1291SB BMH44MT EYE TRAY 1291SB BX0003 BREAST BIOPSY TRAY 1291SB BXQ007 BREAST BIOPSY PACK 1291SB CH12CO SHOULDER ARTHROSCOP. 3943SB CHMC01CO INTERVENTIONAL PACK 3943SB CMC06MF UNIBLOCK-UNIV. NERVE BLOCK 1291SB CTS01D0 RECOVERY TRAY 1241SB CVSCO1MF CATARACT TRAY 1291SB EAP010 LATEX FREE-TYMPANOPLASTY 3943SB ECM01ET ANGIOGRAPHY PACK 3943SB ECMC01ENJ OPHTHALMIC PACK 1291SB EYJ101 EYE PACK 3943SB EYP017 ED JONES EYE TRAY 3943SB EYP071 EYE TRAY 3943SB EYP091 MINI OPHTHALMIC CUSTOM KIT 3943SB GSH0301 VALVE A & B PACK 3943SB GSH04D1 CORONARY TRAY A & B 3943SB GSM065 VASECTOMY PACK 3943SB GSP025 BONE MARROW TRAY 0110 HCL372 ANGIOGRAPHY PACK 3943SB HCP001 CARDIAC CATH PACK 3943SB HMEM01ST CR. TERRELL CATARACT PACK 3942SB MUPO1PP CATARACT PACK 1291SB 1MH12M1 ANESTHESIA BUNDLE CMS 1241SB JPSH29FWT BALLOON INDUCTION TRAY 3943SB MCG05AG PEDIATRIC CARDIAC CATH 3943SB MGH01SW OPHTHALMIC PACK 3943SB M113MA ANGIOGRAPHY TRAY 3943SB M146MA MYLOGRAM 3943SB MMH17BF EYE PACK 3943SB MMH18BF POSTERIOR VITRECTOMY 3943SB MVH22DO LATEX FREE TYMPANOPLASTY 3943SB NNJEO1SONJ BASIC EYE PACK 3943SB OBP049 VAGINAL DELIVERY TRAY 3943SB OLTRMC04CI CATARACT TRAY 3943SB OPP195 PODIATRY SET UP PACK 0110 PLP020 PLASTIC PACK 3943SB RD3548 ELECTRO-PHYSIOLOGY TRAY 3943SB SCH08ECI TOTAL HIP TRAY 3943SB SH01SP CATARACT TRAY 3943SB SHH01CM CATARACT PACK 3943SB SJO7SI BLEEDER SET UP PACK 3943SB SRH01GG CATH PACK 3943SB SRHO1SO DR. ROBINSON’S EYE PACK 3943SB TH11CHI DIALYSIS KIT 0110 THMC12CI P.A.C. KIT 0110 UHCO1CM CATARACT PACK 3943SB VAMCC01CO ANGIO ARTERIOGRAM CV15101 3943SB VAMCC02CO BASIC CATH LAB PK CV15103 3943SB VBH02LV OPEN HEART A/B/C 3943SB WPAFB16WPO PODIATRY PACK PO22001 3943SB REASON: STERILE SURGICAL KITS MAY CONTAIN NONSTERILE CLINIPAD PRODUCTS. MANUFACTURER/RECALLING FIRM: MAXXIM MEDICAL, INC., NORTH CLEARWATER, FL RECALLED BY: The firm sent a "Clinipad Drug Recall" letter out on 3/30/2000 (dated 3/23/2000). FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Canada QUANTITY: Approx. 1,000,000 kits potentially with Clinipad product.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0659-1, 1/4 X 1/2 X 1/2 Clear PAY with Luer Lock. 10 pouched/labeled units per box. REASON: Nonsterile product labeled non-sterile contained a sterile catalog number and should have been sterile MANUFACTURER/RECALLING FIRM: SURGIMEDICS, INC., THE WOODLANDS, TX RECALLED BY: LifeStream International, Inc, The Woodlands, TX, by letter on 7/25/00 FIRM INITIATED RECALL: Terminated DISTRIBUTION: St. Louis, MO QUANTITY: 70 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-700-1, Passport 2 Vital Signs Monitor Codes: Passport 2 0998-00-0170-0001(A,F) Passport 2 0998-00-0170-0002 (A,D,F,G,P,T) Passport 2 0998-00-0170-0003 (A) Passport 2 0998-00-0170-0004 (A,G) Passport 2 0998-00-0170-0005 (A) Passport 2 0998-00-0170-0006 (A,D,G) Passport 2 0998-00-0170-0007 (A) Passport 2 0998-00-0170-0008 (A) Passport 2 0998-00-0170-0009 (A,F) Passport 2 0998-00-0170-0010 (A,F,G) Passport 2 0998-00-0170-0011 (A) Passport 2 0998-00-0170-0012 (A,G,P) Passport 2 0998-00-0170-0013 (A,D,F,T) Passport 2 0998-00-0170-0014 (A,F,G,T) Passport 2 0998-00-0170-0015 (A) Passport 2 0998-00-0170-0016 (A) Passport 2 0998-00-0170-0017 (A) Passport 2 0998-00-0170-0021 (A) Passport 2 0998-00-0170-0022 (A) Passport 2 0998-00-0170-0023 (A) Passport 2 0998-00-0170-0029 (A) Passport 2 0998-00-0170-0031 (A) Passport 2 0998-00-0170-0032 (A) Passport 2 0998-00-0170-0034 (A,F,P) Passport 2 0998-00-0170-0036 (A,P) Passport 2 0998-00-0170-0037 (A) Passport 2 0998-00-0170-0038 (A,F,G,T) Passport 2 0998-00-0170-0039 (A) Passport 2 0998-00-0170-0040 (A,P) Passport 2 0998-00-0170-0041 (A) Passport 2 0998-00-0170-0042 (A,F) Passport 2 0998-00-0170-0044 (A,P) Passport 2 0998-00-0170-0045 (A,F) Passport 2 0998-00-0170-0046 (A,F,G,P,T) Passport 2 0998-00-0170-0048 (A,P) Passport 2 0998-00-0170-0050 (A) Passport 2 0998-00-0170-0054 (A) Passport 2 0998-00-0170-0055 (A) Passport 2 0998-00-0170-0061 (A) Passport 2 0998-00-0170-0062 (A) Passport 2 0998-00-0170-0064 (A) Passport 2 0998-00-0170-3006 (A,T) Passport 2 0998-00-0170-3013 (A) Passport 2 0998-00-0170-3014 (A,F,G,T) Passport 2 0998-00-0170-3015 (A) Passport 2 0998-00-0170-3016 (A,G) Passport 2 0998-00-0170-3038 (A,T) Passport 2 0998-00-0170-3040 (A,P) Passport 2 0998-00-0170-3045 (A) Passport 2 0998-00-0170-3046 (A,F,G,T) Passport 2 0998-00-0170-3047 (A) Passport 2 0998-00-0170-3048 (A,G,T) REASON: Power supply fails when the printer/recorder is activated. MANUFACTURER/RECALLING FIRM: Datascope Corporation, Mahwah, NJ RECALLED BY: By letter on 5/25/01. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: Nationwide and Austria, Belgium, Brazil, Chile, China, Czech Republic, Egypt, France, Germany, Greece, Guatemala, Holland, Hungary, India, Israel, Italy, Jordan, Kuwait, Mexico, Peru, Philippines, South Africa, Spain, Syria, Thailand, Tunisia, Turkey, United Kingdom, Venezuela, Vietnam, Zambia. QUANTITY: 1520 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0715-1, Dura II Concealable Penile Prosthesis (in sterile packaging) with 1 Pair of 10 mm Bodies, Part Number 9310, Lot/Serial Number: 007695, Catalog Number: 9310, Expiration: 2005-10, (stands for October 2005) REASON: 12 mm hex wrenches put in 10 mm Dura II penile prosthesis kits MANUFACTURER/RECALLING FIRM: TIMM MEDICAL TECHNOLOGIES, INC., PRAIRIE, MN RECALLED BY: Initially each account was telephoned. A letter dated 2/23/01 was sent to the customers explaining the problem. FIRM INITIATED RECALL: Complete DISTRIBUTION: MT, TX, PA QUANTITY: 4 devices _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0729-1, ACE 2.0 PTCA Dilatation Catheters (2.0 mm diameter balloon size), Model Number H74902071011 Z-0730-1, Graft ACE 2.0 PTCA Dilatation Catheters (2.0 mm diameter balloon size), Model Number H74903647201 Z-0731-1, ACE 1 cm TIP 2.0 PTCA Dilatation Catheters (2.0 mm diameter balloon size), Model Number H74903628201 CODE: Lot numbers 3367926 and above REASON: Slow or no balloon deflation was noticed during final functional testing of some of the catheters. MANUFACTURER/RECALLING FIRM: BOSTON SCIENTIFIC SCIMED, INC. MAPLE GROVE, MN RECALLED BY: Consignees were notified by an "Urgent Recall Notice" dated February 23, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 1284 Catheters _______________________________ RECALL NUMBER, PRODUCT AND CODE: Ventak Prism Automatic Implantable Cardioverter Defibrillators Serial Numbers: Z-0732-1, Ventak Prizm VR Model 1850: 103440-103442, 103447-103470, 103472-103473, 103475, 103479-103515, 103517-103847, 103849-103880, 103882-104235, 104237-104883, 104885- 104886, 104888, 104891-105008, 105010-105949, 105951-106009, 106012- 109299, 109301-109303, 109305-109845 Z-0733-1, Ventak Prizm DR Model 1851: 307946, 307972, 307976, 307988, 307995-308002, 308006-308007, 308009, 308011, 308016, 308019-308020, 308026-308028, 308030- 308047, 308054, 308069-308075, 308077-308115, 308118-308146, 308148- 308155, 308158-308269, 308271-308285, 308288-308309, 308311-308320, 308322-308326, 308328-308388, 308390-308406, 388408-308431, 308433- 308434, 308436-308437, 308439-308665, 308667-308699, 308701-308713, 308715-308747, 308749-308790, 308792-308825, 308827-388970, 308972- 308989, 308991, 308993-309294, 309296-309509, 309511-309842, 309844- 310083, 310085-310095, 310098-310101, 310104-310105, 310108-310111, 310128-310175, 310177-310222, 310224-310225, 310227-310248, 310251- 310307, 310309-310329, 310335-310337, 310341-310387, 310389-310409, 310411-310943, 310945-311423, 311425-312590, 312592-312815, 312817- 313201, 313203-314612 Z-0734-1, Ventak Prizm VR HE Model 1852: 100000-100507 Z-0735-1, Ventak Prizm DR HE Model 1853 300005-300011, 300013-300014, 300017, 300019-300020, 300022, 300031- 300033, 300035, 300037-300038, 300045-300063, 300065-300066, 300068- 300150, 300152, 300154-300280, 300282-300286, 300288-300317. 300319- 300324, 300326-301611 Z-0736-1, Ventak Prizm VR HE Model 1857 500000-500123 Z-0737-1, Ventak Prizm DR HE Model 1858 600000-600129 REASON: Some of the defibrillators have automatically switched to an integrated Safety Mode because of a rare interaction between the device and a specific memory component. MANUFACTURER/RECALLING FIRM: GUIDANT CORPORATION, CARDIAC PACEMAKERS, ST. PAUL, MN RECALLED BY: The firm's action consists of two parts. Unused devices are to be retrieved, from consignees, by the firm's sales people. As the second part of the action, an "Important Patient Management Information" letter dated April 23, 2001 was sent to all physicians who are monitoring patients with the devices or are registered as having implanted the devices. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and worldwide QUANTITY: 13,833 defibrillators _______________________________ RECALL NUMBER, PRODUCT AND CODE: Seal-Away Coronary Sinus Introducer Kit, Reorder Numbers 407508 & 407510 Lot number and expiration date: Reorder Number 407508: Z-0738-1, LOT NUMBER EXPIRATION DATE 00BG78 5/2003 00CB68 7/2003 00CC67 7/2003 00CP20 9/2003 00CZ26 10/2003 99BY99 9/2002 99CP40 11/2002 99CP41 12/2002 99CP42 12/2002 Reorder Number 407510: Z-0739-1, LOT NUMBER EXPIRATION DATE 01BB96 3/2004 00AY18 4/2003 00CD87 8/2003 00CP77 9/2003 99CU58 12/2002 REASON: It is possible for the Seal-Away CS sheath to split upon insertion. MANUFACTURER/RECALLING FIRM: ST. JUDE MEDICAL, INC., DAIG DIVISION, MINNETONKA, MN RECALLED BY: Beginning June 22, 2001, the firm's sales representatives visited consignees, and delivered an "Urgent - Product Removal Letter" dated June 22, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide; United Kingdom and Ireland QUANTITY: 2303 units (1889 units of product 407508 and 414 units of product 407510 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0740-1, Medtronic GEM Implantable Cardioverter Defibrillators, Model 7227, with Interchangeable Connector, Model 5227 REASON: Even though the devices will continue to provide therapy, the physician is led to believe that a lead failure has occurred. As a result, lead replacement would probably be chosen in some cases when it is unnecessary. MANUFACTURER/RECALLING FIRM: MEDTRONIC, INC., MINNEAPOLIS, MN RECALLED BY: Physicians were sent an "Important Patient Management Information" letter dated December 20, 2000. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and worldwide QUANTITY: 1352 devices _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0742-1, Silhouette Spinal Fixation System Torque-Limiting T-Handle Driver, Catalog Number: 7010-0019-00. The Torque-Limiting T-Handle Drivers were each distributed in a case of instruments labeled "SILHOUETTE SCREW INSTRUMENT GENERIC CASE COMPLETE SET: 7050-0000-00". CODE: All lots REASON: The calibration of the device can be affected if the adjustment screws are altered. MANUFACTURER/RECALLING FIRM: BEEVE PRECISION, RACINE, WI RECALLED BY: The firm's sales people conducted the recall. They were sent an October 30, 2000 "Confidential Memorandum", which requested that the Torque-Limiting T-Handle Drivers be removed from the instrument kits in distribution and be returned to the firm. FIRM INITIATED RECALL: Complete DISTRIBUTION: About 300 of the instrument kits are in distribution in the United States (owned by the firms sales reps.) One instrument kit has been sold to a hospital in LaCrosse, WI. There are distributors of the instrument kits in Australia, China, South Korea and Switzerland. 51 of the kits were sold to consignees in these countries. QUANTITY: 371 devices _______________________________ RECALL NUMBER, PRODUCT AND CODE: Myotherm Cardioplegia Delivery System, XP 4:1 (catalog number 61399404996) and XP 4:1B (catalog number 61399405331). The XP 4:1B differs from the XP 4:1 by having a bridge connection which the XP 4:1 does not have. Z-0746-1, MYOtherm XP 4:1 (catalog number 61399404996): lot number 0006013298 Z0747-1, MYOtherm XP 4:1B (catalog number 61399405331): lot number 0006014173 REASON: Some of the devices are mislabeled as to whether they have a bridge connection. MANUFACTURER/RECALLING FIRM: MEDTRONIC, INC., MINNEAPOLIS, MN RECALLED BY: MEDTRONIC PERFUSION SYSTEMS, MINNEAPOLIS, MN, sent an "URGENT - Field Action" letter dated September 20, 2000 to the users of the products. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: 290 Cardioplegia Delivery SystemsEND OF ENFORCEMENT REPORT FOR Aug 8, 2001. ####
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