April 30, 1997 97-18 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============ _______________ PRODUCT Mayport Ocean Gallery Recipe Smoked Salmon Spread, packed into 6.5 ounce plastic tubs. Recall #F-399-7. CODE Sell by date March 2, 1997 and February 25, 1997. MANUFACTURER Mayport Wholesale Seafood, Inc., Green Cove Springs, Florida. RECALLED BY Manufacturer, by press release on January 29, 1997. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 27 cases (20 cans per case) were distributed. REASON Product was contaminated with Listeria monocytogenes. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT BestYet Cookies, 20 ounce size: (a) Assorted Cookies; (b) Duplex Cookies, (c) Peanut Butter Cookies; (d) Vanilla Sandwich Creams. Recall #F-310/313-7. CODE FEB 5 1997 through JUL 10 1997. MANUFACTURER Bakeline Products, Inc., Des Plaines, Illinois. RECALLED BY Fleming, Inc., Oklahoma City, Oklahoma. Firm- initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY (a) 538 cases; (b) 512 cases; (c) 625 cases; (d) 669 cases were distributed. REASON The product is misbranded due to the failure to display required labeling in accordance with 21 CFR 101.5 _______________ PRODUCT Triton Mountain Spring Water, in 8 ounce bottles. Recall #F-380-7. CODE 10-24-98-A. MANUFACTURER Triton Water Company, Burlington, North Carolina. RECALLED BY Manufacturer, by telephone/letter on or about December 9, 1996. Firm-initiated recall ongoing. DISTRIBUTION New Jersey. QUANTITY 17,280 bottles were distributed. REASON Product is contaminated with mold. _______________ PRODUCT Various soft drinks: 1. Coca-Cola Classic, 12 fl. ozs./cans, 20 fl. ozs./bottles, 2 Liter/bottles 2. Caffeine-Free Coca-Cola Classic,12 fl. ozs./cans, 2 Liter/bottles 3. Cherry Coke, 20 fl. ozs./bottles 4. Diet Coke, 12 fl. ozs./cans, 20 fl. ozs./bottles, 2 Liter/bottles 5. Caffeine-Free Diet Coke, 12 fl. ozs./cans, 2 liter/bottles 6. Mr. Pibb, 20 fl. ozs./bottles 7. Dr. Pepper, 12 fl. ozs./cans, 20 fl. ozs./bottles, 2 Liter/bottles 8. Diet Dr. Pepper, 12 fl. ozs./cans, 20 fl. ozs./bottles, 2 Liter/bottles 9. Barq's Root Beer, 12 fl. ozs./cans, 20 fl. ozs./bottles 10. Sprite, 12 fl. ozs./cans, 20 fl. ozs./bottles, 2 Liter/bottles 11. Diet Sprite, 12 fl. ozs./cans, 2 Liter/bottles 12. Mello Yello, 12 fl. ozs./cans, 20 fl. ozs./bottles, 2 Liter/bottles 13. Minute Maid Fruit Punch, 20 fl. ozs./bottles 14. Minute Maid Grape, 12 fl. ozs./cans, 20 fl. ozs./bottles 15. Minute Maid Orange, 12 fl. ozs./cans, 20 fl. ozs./bottles -2- 16. Schweppes Ginger Ale, 20 fl. ozs./bottles 17. Surge, 12 fl. ozs./cans, 20 fl. ozs./bottles, 2 Liter/bottles. Recall F-381/397-7. CODE Any of the listed products with codes as identified below: All products in plastic non-returnable bottles and diet soft drinks in aluminum cans with the following codes: MAY1297CVA; MAY1297CVB; MAY1297CVC; MAY1297CVD; MAY1297CVE; MAY1297CVF; MAY1297CVG; MAY1997CVA; MAY1997CVB; and MAY1997CVC. All regular (non-diet) soft drinks in aluminum cans with the following codes: NOV1097CVA; NOV1097CVB; NOV1097CVC; NOV1097CVD; NOV1097CVE; NOV1097CVF; NOV1097CVG; NOV1797CVA; NOV1797CVB; and NOV1797CVC. MANUFACTURER Johnston Coca Cola Bottling Company, Division of Coca Cola Enterprises, Cleveland, Tennessee. RECALLED BY Manufacturer, by visit. Firm-initiated recall ongoing. DISTRIBUTION Tennessee, Alabama, Georgia. QUANTITY Approximately 301,490 cases were distributed; firm estimates none remains on the market. REASON Products have an off-odor and off-flavor. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II =========== _______________ PRODUCT Transfilled Compressed Medical Oxygen USP filled into E size cylinders. Recall #D-168-7. CODE All codes, all lots and all fill dates. MANUFACTURER Respiratory Science Industries, Ltd., Elmont, New York. RECALLED BY Manufacturer, by telephone on April 11, 1997, followed by letter on April 14, 1997. Firm- initiated recall ongoing. DISTRIBUTION New York. QUANTITY 81 cylinders were distributed. REASON Current good manufacturing practice deficiencies. _______________ PRODUCT Indomethacin Suppositories USP, 50 mg, Rx nonsteroidal anti-inflammatory agent, under the Qualitest, Zenith and G&W labels. Recall #D-169-7. CODE All lots within expiration date. -3-MANUFACTURER G & W Laboratories, Inc., South Plainfield, New Jersey. RECALLED BY Manufacturer, by letter dated January 30, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 20 lots were distributed. REASON Product lacks stability (potency assay is as low as 58% of labeled strength). RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ========== _______________ UPDATE Recall #D-156-7, which appeared in the April 23, 1997 Enforcement Report should have been listed as Nycomed brand Hypaque (Diatrizoate Sodium) Oral Solution. The powder is not included in this recall action. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT Red Blood Cells. Recall #B-618-7. CODE Unit numbers: 2226275, 2226277, 2226941, 2226279, 2226942, 2226276, 1812016, 1812489, 1812001, 1812492, 1812003, 1812491, 2227887, 2226955, 1812490, 1812000. MANUFACTURER Oklahoma Blood Institute, Oklahoma City, Oklahoma. RECALLED BY Manufacturer, by fax followed by letter on January 25, 1996. Firm-initiated recall ongoing. DISTRIBUTION Massachusetts, Oklahoma, Texas, California. QUANTITY 16 units were distributed. REASON Blood products were prepared from units of Whole Blood that were stored at room temperature for more than 12 hours. _______________ PRODUCT Red Blood Cells. Recall #B-619-7. CODE Unit #5112340. MANUFACTURER Department of the Navy, Naval Hospital, Beaufort, South Carolina. RECALLED BY Manufacturer, by requesting destruction of unit on June 19, 1996. Firm-initiated recall complete. DISTRIBUTION South Carolina. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose health history screening was inadequately performed. -4-_______________ PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-626/627-7. CODE Unit #03GH16722. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by letter dated November 14, 1996, by telephone on November 8, 1996, followed by letter dated November 13, 1996. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 1 unit of each component. REASON Blood products were collected from a donor who traveled in an area considered endemic for malaria. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma; (d) Recovered Plasma. Recall #B-630/633-7. CODE Unit numbers: (a) 26F00593, 26G09071, 26G10174, 26G11575, 26G79656, 26G95204, 26L81709, 26N08544, 26FF00501 (b) 26F00593, 26G09071, 26G79656, 26G95204, 26N08544, 26FF00501 (c) 26G10174, 26G79656, 26G95204, 26N08544 (d) 26F00593, 26G09071, 26G11575, 26L81709, 26FF00501. MANUFACTURER American Red Cross Blood Services, Mobile, Alabama. RECALLED BY Manufacturer, by various letters dated in March 1995. Firm-initiated recall complete. DISTRIBUTION Alabama, Florida, Mississippi. QUANTITY (a) 9 units; (b) 6 units; (c) 4 units; (d) 5 units were distributed. REASON Blood products were collected from donors with a history of IV drug use. _______________ PRODUCT Platelets, Pheresis. Recall #B-639-7. CODE Unit #7346334. MANUFACTURER Northwest Oklahoma Blood Institute, Enid, Oklahoma. RECALLED BY Oklahoma Blood Institute, Oklahoma City, Oklahoma, by telephone on September 25, 1996, followed by fax. Firm-initiated recall complete. DISTRIBUTION Oklahoma. QUANTITY 1 unit was distributed. REASON Blood product was collected in a mixture of anticoagulants. -5-_______________ PRODUCT Platelets, Pheresis. Recall #B-640-7. CODE Unit #11LF04929. MANUFACTURER American Red Cross Blood Services, Jefferson City, Missouri. RECALLED BY American Red Cross Blood Services, St. Louis, Missouri, by telephone on April 22, 1996, followed by letter dated April 26, 1996. Firm-initiated recall complete. DISTRIBUTION Missouri. QUANTITY 1 unit was distributed. REASON Blood product had saline inappropriately added instead of plasma. _______________ PRODUCT Red Blood Cells. Recall #B-642-7. CODE Unit #49FM24988. MANUFACTURER American Red Cross Blood Services, Wichita Falls, Texas. RECALLED BY Manufacturer, by letter dated January 27, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who was taking the drug Methotrexate. _______________ PRODUCT Recovered Plasma. Recall #B-643-7. CODE Unit #55C03757. MANUFACTURER American Red Cross Blood Services, Little Rock, Arkansas. RECALLED BY Manufacturer, by telephone on February 12, 1997, followed by letter dated March 3, 1997. Firm-initiated recall complete. DISTRIBUTION Arkansas. QUANTITY 1 unit was distributed. REASON Blood product was not tested for viral markers. _______________ PRODUCT Platelets. Recall #B-645-7. CODE Unit #49Y36552. MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma. RECALLED BY Manufacturer, by telephone on December 27, 1996, followed by letter January 27, 1997. Firm-initiated recall complete. DISTRIBUTION Oklahoma. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of Whole Blood designated as a difficult collection. -6-_______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-646/647-7. CODE Unit numbers: (a) 49LF19278, 49LF25666; (b) 49LF19278, 49LF25666, 49LF13568. MANUFACTURER American Red Cross Blood Services, Waco, Texas. RECALLED BY Manufacturer, by letter dated January 15, 1997 and on January 7, 1997. Firm-initiated recall complete. DISTRIBUTION Texas and Virginia. QUANTITY (a) 2 units; (b) 3 units were distributed. REASON Blood products were collected from a donor who was taking the drug Methotrexate. _______________ PRODUCT Platelets. Recall #B-648-7. CODE Unit #49R76871. MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma. RECALLED BY Manufacturer, by letter dated February 3, 1997. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of Whole Blood designated as a difficult collection. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-650/651-7. CODE Unit #4003410. MANUFACTURER Community Blood Center, Dayton, Ohio. RECALLED BY Manufacturer, by telephone on August 26, 1996. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected in a manner which could compromise the sterility of the collection system. _______________ PRODUCT (a) Red Blood Cells; (b) Cryoprecipitated AHF. Recall #B-652/653-7. CODE Unit #21GJ69700. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter dated March 14, 1997. Firm-initiated recall complete. DISTRIBUTION Oregon. QUANTITY 1 unit of each component was distributed. -7-REASON Blood products were collected from a donor with a history of Hodgkin Disease. _______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-654/655-7. CODE Unit #53M07743. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated October 29, 1996. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 unit of each component was distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1, Western blot negative. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT Thrombostat (Thrombin, USP-Bovine Origin). Recall #B-528-7. CODE Lot #00556P EXP 2/16/99. MANUFACTURER Parke-Davis, Sterile Products Division, Rochester, Michigan. RECALLED BY Parke-Davis, Division of Warner-Lambert Company, Morris Plains, New Jersey, by letter February 27, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 5,915 vials were distributed. REASON Parke-Davis improperly made fill volume adjustments for potency of the product. _______________ PRODUCT Baxter Gammagard & Polygam Solvent/Detergent Treated Infusion Sets (Immune Globulin Intravenous(Human): (a) Baxter's Gammagard S/D 5G (b) Baxter's Gammagard S/D 10G (c) Baxter's Polygam S/D 5G (d) Baxter's Polygam S/D 10G. Recall #B-579/582-7. CODE Lot number after 2620E061AA and after 26206056AA. MANUFACTURER Baxter Healthcare Corporation, Glendale, California. RECALLED BY Manufacturer, by letter dated November 15, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. -8-QUANTITY Approximately 232,921 units were distributed. REASON Baxter's IGIV solvent/detergent infusion sets, have defective transfer devices which pushes the stopper into vials of accompanying sterile water injection producing particulate matter. _______________ PRODUCT Platelets. Recall #B-585-7. CODE Unit #32KJ08285. MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin. RECALLED BY Manufacturer, by letter dated May 1, 1996. Firm-initiated recall complete. DISTRIBUTION Wisconsin. QUANTITY 1 unit was distributed. REASON Blood product tested positive for Bg antibodies. _______________ PRODUCT Platelets, Pheresis. Recall #B-586-7. CODE Unit #29FP31456. MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by letters dated February 9, 1996, March 12, 1996, and April 12, 1996. Firm-initiated recall complete. DISTRIBUTION Oklahoma. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who was immunized with Chicken Pox vaccine. _______________ PRODUCT Platelets, Pheresis. Recall #B-597-7. CODE Unit numbers 11LK22485 and 11P26884. MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri. RECALLED BY Manufacturer, by telephone on or about June 17, 1996, followed by letter dated June 27, 1996. Firm-initiated recall complete. DISTRIBUTION Missouri. QUANTITY 2 units were distributed. REASON Blood products were labeled with extended expiration dates. _______________ PRODUCT Red Blood Cells. Recall #B-613-7. CODE Unit #41GK78109. MANUFACTURER American Red Cross Blood Services, Birmingham, Alabama. RECALLED BY Manufacturer, by telephone in September 1996, followed by letter dated September 12, 1996. Firm-initiated recall complete. DISTRIBUTION Alabama. -9-QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. _______________ PRODUCT Red Blood Cells. Recall #B-620-7. CODE Unit numbers: 21GF83275 and 21GF83285. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by telephone on August 12, 1996. Firm-initiated recall complete. DISTRIBUTION Oregon. QUANTITY 2 units were distributed. REASON Blood products were labeled with extended expiration dates. _______________ PRODUCT Red Blood Cells. Recall #B-625-7. CODE Unit #21GF89063. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by telephone on October 14, 1996. Firm-initiated recall complete. DISTRIBUTION Oregon. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. _______________ PRODUCT Cryopreipitated AHF. Recall #B-629-7. CODE Unit #53FL57453. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated October 31, 1996. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of Whole Blood with an extended collection time. _______________ PRODUCT Red Blood Cells. Recall #B-634-7. CODE Unit #26FP06215. MANUFACTURER American Red Cross, Mobile, Alabama. RECALLED BY Manufacturer, by telephone in March 1995. Firm-initiated recall complete. DISTRIBUTION Alabama. QUANTITY 1 unit was distributed. REASON Blood product was exposed to improper storage and unacceptable temperatures. -10-_______________ PRODUCT Elase Ointment (Fibrinolysin & Desoxyribonuclease Combined (Bovine) Ointment). Recall #B-636-7. CODE Lot #52D4 EXP 9/97. MANUFACTURER Parke-Davis, Sterile Products Division, Rochester, Michigan. RECALLED BY Parke-Davis, Division of Warner-Lambert Company, Morris Plains, New Jersey, by letter on May 16, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 35,328 tubes were distributed. REASON Product failed the 15 month 30 degree C stability assay for desoxyribonuclease. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Baxter Capillary Flow Dialyzer, Model CF 15 5M1709, containing fibers from FNR 981, used with an artificial kidney system for the treatment of patients with renal failure or toxemic conditions. Recall #Z-347-7. CODE Lot H97A14169. MANUFACTURER Baxter Healthcare Corporation, Mountain Home Arizona. RECALLED BY Manufacturer, by telephone on February 17, 1997. Firm-initiated recall ongoing. DISTRIBUTION California, New Jersey, Pennsylvania, New Mexico, Illinois, Missouri, Texas, New York. QUANTITY 1,632 units were distributed. REASON The blood in the dialyzer clearance values fluctuate from the labeled values for the dialyzer. _______________ PRODUCT Infant Monitor, Model 500EXL, available for hospital and home use to monitor respiration, ECG and heart rate: (a) Catalog number: 0500FAA 120 Volts/ 60 Hz English; (b) Catalog number: 0500FAH 230 Volts/ 50 Hz English; Catalog number: 0500FEH 230 Volts/ 50 Hz German. Recall #Z-419/421-7. CODE Serial Numbers: Cat. No.: 0500FAA: 01008736, 01110442, 01313163, 01615535, 01615537 - 01615544 - 01615546 - 01615553, 03313340 04301233, 0482335, 06414241, 07313642, 08111333, 08212735, 08301216, 0882959, 0882984, 09009743, 09009748, 09009758, 09009779, 0983171, 11313882, 11515405-11515408, 11515410 - 11515429, -11- 11907334, 12213073, 12515449 - 12515458, 12515461, 12515462, 12515464, 12515465, 12515466, 12515468 - 12515472, 12515474 - 12515479, 12515481 - 12515487, 12515491 - 12515498, 13000022, 13000023, 13000025, 13000031, 13000034, 13000036, 13000038 - 13000040, 13000042, 13000044, 13000046-13000048, 13000050, 13000052, 13000076 - 13000115, 13000136-13000225, 13000227 - 13000241, 13000263 - 13000265, 13000321 - 13000341, 13000349 - 13000351, 99000002 - 99000015 Cat. No.: 0500FAH: 12515530, 13000002 Cat. No.: 0500FEH: 13000000, 13000010 - 13000051, 13000061, 13000072 - 13000076, 13000081 - 13000084. MANUFACTURER Corometrics Medical Systems, Inc., Wallingford, Connecticut. RECALLED BY Manufacturer, by Product Notification letter on March 6, 1997, and by fax. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 327 monitors were distributed. REASON The battery operating time has been shown to be less than the 16 hours specified due to an integrated circuit (IC) which was found to draw too much current. _______________ PRODUCT Passport Monitors with saturated oxygen measurement (SP02) Capability supplied by Nellcor Medical Systems, used to monitor CO2, respiration, temperature, and non-invasive blood pressure. Recall #Z-444/446-7. CODE (a) Model No. 0998-00-0095N01 - N04, N41-N44, N61-64, B01-04, B41-B44, B61-B64; (b) Model No. 0998-00-0126N01 - N04, N41-N44, N61-64, B41-B44, B61-B64; (c) Model No. 0998-00-0133N42. Recall #Z-444/446-7. MANUFACTURER Datascope Corp., Paramus, New Jersey. RECALLED BY Manufacturer, by letter dated August 2, 1996. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 1,046 units were distributed. REASON Due to a noisy power supply line on the Passport, the Nellcor SP02 module provides low readings of SP02. -12-_______________ PRODUCT Novametrix Model 520A Oxypleth Pulse Oximeter with software version 2.6, used to provide measurement, display and alert for functional pulsatile oxygen saturation (SP02) and pulse rate. Recall #Z-454-7. CODE Software Version 2.6. MANUFACTURER Novametrix Medical Systems, Inc., Wallingford, Connecticut. RECALLED BY Manufacturer, by letter on March 3, 1997. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY 3,364 units were distributed. REASON There is a software error associated with the displayed pulse rate alert parameter. Under certain monitoring set-ups, the actual pulse rate alert limits set in the monitor may not be the same as those shown on the display. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT Coatest APC Resistance Diagnostic Test Kits. Recall #Z-427-7. CODE Type -SC Kits, Lot Nos. X3118 and X3235; Type -C Kits, Lot. No. X3234. MANUFACTURER Chromogneix AB, Nykoping, Sweden. RECALLED BY DiaPharma Group, Inc., Franklin, Ohio (importer/distributor), by letter on March 19 and 20, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 204 kits were distributed. REASON The plasma controls in the kits are yielding results which are out of specification. _______________ PRODUCT Micro Jewel Arrhythmia Management Device, Model 7221Cx. Recall #Z-437-7. CODE MODEL 7221Cx BUILT WITH CONNECTOR MODULE PART NUMBER 149312-004 FROM THE FOLLOWING LOTS: Lot No. Serial No. 557723 PFK202624H 571132 PFK200059H 571132 PFK200110H 571513 PFK200260H 571513 PFK200291H 571513 PFK200301H 571513 PFK200304H 571513 PFK200401H 571513 PFK200403H 571513 PFK200444H -13- Lot No. Serial No. 571513 PFK200447H 572744 PFK200148R 572744 PFK200195R 572744 PFK200270R 572744 PFK200398R 572744 PFK200399R 572744 PFK200449R 572744 PFK200470R 573320 PFK200556R 573320 PFK201432H Lot No. Serial No. 573320 PFK201483H 573320 PFK201690H 573320 PFK201717H 573320 PFK201718H 573320 PFK201720H 573320 PFK201721H 573320 PFK201722H 573320 PFK201724H 573320 PFK201727H 573320 PFK201728H 573320 PFK201735H 573320 PFK201738H 573320 PFK201748H 573320 PFK201749H 573599 PFK200354H 573599 PFK200373R 573599 PFK200426H 573599 PFK200493H 573599 PFK200520H 573599 PFK200626H 573599 PFK201612H 573599 PFK201661H 573599 PFK201701H 574366 PFK200376H 574366 PFK200578H 574366 PFK200602H 574366 PFK200607H 574451 PFK200555H 574451 PFK200601R 574451 PFK200647H 574451 PFK200655H 574451 PFK200701H 574451 PFK200712R 574451 PFK200779H 574564 PFK200650H 574564 PFK200676H 574564 PFK200679R 574564 PFK200680R 574564 PFK200688H 574564 PFK200688R -14- 574564 PFK200715H 574564 PFK200724H 574564 PFK200765H 574650 PFK200086R Lot No. Serial No. 574650 PFK200318H 574650 PFK200581R 574650 PFK200706H 574650 PFK200743H 574650 PFK200848H 574650 PFK200874H 574891 PFK200113H 574891 PFK200856H 574891 PFK200922H 574891 PFK200981H 575083 PFK200888H 575143 PFK200979H 575143 PFK200982H 575143 PFK200993H 575143 PFK200996H 575143 PFK201033H 575143 PFK201141H 575143 PFK201151H 575245 PFK200559H 575245 PFK200592H 575245 PFK200617H 575245 PFK201139H 575245 PFK201142H 575245 PFK201142H 575245 PFK201144H 575245 PFK201268H 575245 PFK201268H 575245 PFK201269H 575353 PFK201252H 575353 PFK201253H 575353 PFK201253H 575353 PFK201258H 575482 PFK201230H 575482 PFK201232H 575482 PFK201254H 575537 PFK201181H 575537 PFK201182H 575537 PFK201231H 575537 PFK201289H 575537 PFK201294H 575599 PFK201511H 575775 PFK201536H 575775 PFK201600H 575776 PFK200499H Lot No. Serial No. 575776 PFK201368H 575776 PFK201470H -15- 575776 PFK201608H 575778 PFK201358H 575927 PFK200588H 575927 PFK201444H 575927 PFK201445H 575927 PFK201452H 575927 PFK201491H 575927 PFK201622H 576266 PFK201832H 576266 PFK201879H 576266 PFK201913H 576266 PFK201934H 576266 PFK201958H 576266 PFK201960H 576266 PFK201981H 576266 PFK202121H 576359 PFK201820H 576359 PFK201837H 576360 PFK201657H 576360 PFK201782H 576360 PFK201806H 576360 PFK201862H 576447 PFK201907H 576447 PFK202016H 576482 PFK201225H 576539 PFK201829H 576539 PFK201895H 576539 PFK202105H 576765 PFK202881H 576765 PRK202823H 576901 PFK202187H 576901 PFK202195H 576901 PFK202222H 576901 PFK202228H 576901 PFK202388H 576901 PFK202469H 576986 PFK202034H 576986 PFK202046H 576986 PFK202055H 576986 PFK202060H 576986 PFK202081H 576986 PFK202083H Lot No. Serial No. 576986 PFK202117H 576986 PFK202170H 576986 PFK202214H 576986 PFK202220H 577090 PFK202436H 577413 PFK202181H 577413 PFK202291H 577413 PFK202323H 577413 PFK202335H -16- 577413 PFK202338H 577413 PFK202416H 577413 PFK202420H 577413 PFK202437H 577413 PFK202484H 577413 PFK202506H 577413 PFK202533H 577413 PFK202538H 577413 PFK202562H 577413 PFK202594H 577413 PFK202609H 577413 PFK202634H 577413 PFK202635H 577413 PFK202707H 577413 PFK202721H 577413 PFK202743H 577413 PFK202766H 577413 PFK202822H 577723 PFK202604H 577723 PFK202607H 577723 PFK202611H 577723 PFK202615H 577723 PFK202625H 577723 PFK202628H 577723 PFK202670H 577723 PFK202675H 577723 PFK202681H 577723 PFK202692H 577723 PFK202702H 577723 PFK202724H 577723 PFK202734H 577723 PFK202741H 577723 PFK202744H 577723 PFK202826H 577723 PFK202826H Lot No. Serial No. 577723 PFK202886H 577846 PFK202495H 577846 PFK202503H 577846 PFK202660H 577846 PFK202683H 577846 PFK202732H 577846 PFK202759H 577846 PFK202884H 578985 PFK202799H 578985 PFK202800H 578985 PFK202801H 578985 PFK202803H 578985 PFK202847H 578985 PFK202848H 578985 PFK202852H 578985 PFK202858H -17- 578985 PFK202863H 578985 PFK202900H. MANUFACTURER Medtronic Med Rel, Inc., Humacao, Puerto Rico. RECALLED BY Medtronic, Inc., Minneapolis, Minnesota, by device retrieval plan dated March 10, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 2,358 units were distributed. REASON The device was distributed with out-of-specification connector header blocks resulting in device failure due to setscrew problems. _______________ PRODUCT Various size colored "TAMPS" for osteochondral Autograft (5mm, 6mm, 7mm, 8mm, 9mm and 10mm), Catalog numbers AR-1985-05 through AR-1985-10. Recall #Z-442-7. CODE All codes. MANUFACTURER Arthrex, Inc., Naples, Florida. RECALLED BY Manufacturer, by letter on February 14, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 455 units were distributed. REASON There is a potential for the pin in the tamps to become dislodged and fall out. If the pin were to fall out in surgery, it may be hard to retrieve because of its small size. -18- END OF ENFORCEMENT RPORT FOR APRIL 30, 1997. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for