July 30, 1997 97-31 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============ _______________ PRODUCT Pillsbury Sugar Cookies Dough, a refrigerated dough, in 18 ounce retail plastic-wrapped tubes. Recall F-527-7. CODE "Use Before" date of May02. MANUFACTURER The Pillsbury Company, Denison, Texas. RECALLED BY The Pillsbury Company, Minneapolis, Minnesota, by electronic mail and press release on April 21, 1997, followed by visits. Firm-initiated recall complete. DISTRIBUTION Colorado and Texas. QUANTITY 25 cases (12 packages per case) were distributed. REASON Product contains undeclared peanut butter. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Frozen Yellowfin Tuna: a) Sysco classic brand Yellowfin Tuna Steaks Vac Pac, Net wt. 10 lb. Sysco Food Service Houston, Texas (4 ounce steaks & 8 ounce steaks) b) Icybay brand Slade Gorton & Company Inc. Boston, Massachusetts 02118 Yellow Fin Tuna Steak Vac Pac Net. wt. 10 lb (4, 6, & 8 ounce steaks) c) Orca Bay Brand Yellowfin Tuna Steaks Sandwich cut vac pac Net wt. 10 lb. (6, 8, & 12 ounce steaks) d) Alliant Premier brand Vacuum Packed Yellowfin Tuna 8 ounce steaks Net. wt. 10 lb. e) Captain Cove brand Yellow Fin Tuna Steaks Thunnus Albacares f) Orca Bay Seafoods Yellowfin Kabobs Net. wt. 10 lbs. g) Orca Bay Seafoods Tuna Pieces Net wt. 40 lbs. Recall #F-520/526-7. CODE a) P29690 4674 (4 oz.), P29683 4674 (4 oz.), P29681 4674 (8 oz.) b) P29691 4674 (4 oz.), P29688 4674 (6 oz.), P29682 4674 (8 oz.) c) P29689 4674 (6 oz.), P29679 4674 (8 oz.), P29687 4674 (12 oz.); d) P29680 4674 e) P29686 4674; f) P29692 4674 g) P29693 4674. MANUFACTURER Orca Bay Seafoods, Inc., Seattle, Washington. RECALLED BY Manufacturer, by faxing letter dated June 17, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 25,000 pounds were distributed. REASON The product was decomposed and was associated with an incident of scombroid poisoning. _______________ PRODUCT Various cakes decorated with roses containing whipable soy protein: 1. 7" GOLD/FUDGE DECORATED 14619 2. 7" GOLD/WHITE DECORATED 14620, 6854 3. 7" CHOCOLATE FUDGE DECORATED 06856 4. 7" WHITE DECORATED 95141 5. 8" GOLD/WHITE DECORATED 66104, 00505, 6858, 66119 6. 8" CHOCOLATE/WHITE DECORATED 66105 7. 8" CHOCOLATE/FUDGE DECORATED 6960, 66120, 00504 8. 8" WHITE/WHITE DECORATED 95141, 17100, 00510 9. 8" GOLD/WHITE DECORATED (HAPPY BIRTHDAY) 80210 10. 8" CHOCOLATE/WHITE DECORATED (HAPPY BIRTHDAY)80211,1713 11. 8" WHITE/WHITE DECORATED (HAPPY BIRTHDAY) 17114 -2- 12. 10" CHOCOLATE/WHITE DECORATED 12036 13. 10" GOLD/WHITE DECORATED 12035 14. 10" CHOCOLATE/FUDGE DECORATED 12041 15. 1/4 SHEET WHITE/WHITE DECORATED 17103, 00512 16. 1/4 SHEET GOLD/WHITE DECORATED 66101, 00507, 00583 17. 1/4 SHEET CHOCOLATE/WHITE DECORATED 66102, 00508, 00584 18. 1/4 SHEET MARBLE/WHITE DECORATED 66107 19. 1/4 SHEET WHITE/WHITE DECORATED P/D(THIS VARIETY IS REMOVED FROM THE CAKE PAN AND PLACED ON A CARDBOARD WITH A PLASTIC DOME COVER) 94826, 94831 20. 1/4 SHEET GOLD/WHITE DECORATED P/D 14727,4902 21. 1/4 SHEET CHOCOLATE/WHITE DECORATED P/D 14728, 4904, 95146, 94836 22. 1/4 SHEET CHOCOLATE/FUDGE DECORATED P/D 66103, 4906 23. 1/4 SHEET WHITE DECORATED (HAPPY BIRTHDAY) 66122 24. 1/8 SHEET GOLD/WHITE DECORATED 14725, 4922 25. 1/8 SHEET CHOCOLATE/FUDGE DECORATED 04922 26. 1/8 SHEET CHOCOLATE/WHITE DECORATED P/D 14726 27. 1/2 SHEET GOLD/WHITE DECORATED (HAPPY BIRTHDAY) 14925 28. 1/2 SHEET MARBLE/WHITE DECORATED 14923 29. 1/2 SHEET GOLD/FUDGE DECORATED 14921 30. 1/2 SHEET CHOCOLATE/FUDGE DECORATED 14920 31. 1/2 SHEET GOLD/WHITE DECORATED P/D 14729 32. 1/2 SHEET CHOCOLATE/WHITE DECORATED P/D 14730 33. 1/2 SHEET MARBLE/WHITE DECORATED P/D 14719 34. 1/2 SHEET GOLD/WHITE DECORATED 14925 35. 1/2 SHEET CHOCOLATE/WHITE DECORATED 14926 36. FULL SHEET MARBLE/WHITE DECORATED 00921 37. FULL SHEET CHOCOLATE/WHITE DECORATED 00920 38. FULL SHEET GOLD/WHITE DECORATED 00919 39. 8" RED VELVET DOUBLE 99221 30. 8" RED VELVET SINGLE 99240. Recall #F-528/567-7. CODE All product manufactured distributed prior to 6/17/97. MANUFACTURER Knaub's Cakes, Inc., York, Pennsylvania. RECALLED BY Manufacturer, by letter followed by visit. Firm-initiated field correction (relabeling) ongoing. DISTRIBUTION Nationwide. QUANTITY Undetermined. REASON The products contain undeclared soy protein. -3-RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT Old Country brand Garlic-in-water, packed in 32 ounce containers. Recall #F-519-7. CODE 235MAR97. MANUFACTURER Old Country Packers, Duryea, Pennsylvania. RECALLED BY Manufacturer, by telephone on September 12, 1996. Firm-initiated recall complete. DISTRIBUTION New York and Pennsylvania. QUANTITY Undetermined. REASON Product is unfit for food in that it was contained in swollen containers. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II =========== _______________ PRODUCT Vicodin Tablets (Hydrocodone Bitartrate 5 mg/Acetaminophen 500 mg), in bottles of 100 tablets, Rx indicated for the relief of moderate to moderately severe pain. Recall #D-234-7. CODE 7604461 EXP 9/00. MANUFACTURER Knoll Laboratories, A Division of Knoll Pharmaceutical Company, Mount Olive, New Jersey. RECALLED BY Med-Pro, Inc., Lexington, Nebraska (repacker), by telephone on April 15, 1997. Firm-initiated recall ongoing. DISTRIBUTION Colorado. QUANTITY 6,819 bottles were distributed. REASON Tablet mix-up -- Some bottles of Vicodin were found to contain Trilisate Tables (Choline magnesium trisalicyclate). _______________ PRODUCT Bio-Safe Antibacterial Lotion (Triclosan 0.3%), OTC, in 8 fluid ounce bottles and 55 gallon drums. Recall #D-236-7. CODE Lot numbers 6987 (8 ounces) and 7005 (55 gallons). MANUFACTURER Stanford Personal Care, Saugus, California. RECALLED BY Bio-Safe Skin Products, Milwaukie, Oregon, by telephone on June 20, 1997, and by letter sent on June 24, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 56,000 8-ounce bottles and 4 55-gallon drums were distributed. REASON Product is contaminated with Pseudomonas Aeruginosa. -4- RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III =========== _______________ PRODUCT Oxygen USP, Compressed, Rx sold in "H" and "E" cylinders. Recall #D-235-7. CODE Lot numbers: I-100-6331, I-100-6344, I-100-6347, I-100-7148, I-100-7160, I-100-7142, I-100-7132, I-100-7108, I-100-7049, I-100-7071, I-100-7083, I-100-7153, I-100-7030, I-100-7155, I-100-7108, I-100-7100, I-100-7188, I-100-7150, I-100-7066, I-100-7072, I-100-7139, I-100-7029, I-100-7042, I-100-7118, I-100-7080, I-100-7097, I-100-7122, I-100-7091, I-100-7083, I-100-7064. The following serial numbers were also involved in the recall but were not identified by the firm as to what lot it pertains to: LK42359F, LK333977, LK39424F, E478717, LK28723F, E321516, LK128193, LK354975, K101590, E469710, E490036, E261896, E478686, E478751, E429555, E6450026, E429607, E261884, E261896, E478686, E478751, E522872, E53731. MANUFACTURER Praxair Puerto Rico, Inc., Gurabo, Puerto Rico. RECALLED BY Med-Corp/Med Care, Inc., Hato Rey, Puerto Rico, by visits from 6/10-17/97. Firm-initiated recall complete. DISTRIBUTION Puerto Rico. QUANTITY 45 size "H" and 77 size "E" cylinders were distributed. REASON Current good manufacturing practice deviations. _______________ PRODUCT Injectable Rx dental (local anesthetics sold in vacuum-sealed cans of 50 single use cartridges (capsule) each containing 1.8 ml solution: a) Carbocaine 2% (36 mg) with Neo-Cobefrin 1:2000 Injection (Mepivacaine Hydrochloride/Levonordefrin Injection, USP); b) Lidocaine HCL 2% and Epinephrine 1:50,000 Injection (Lidocaine Hydrochloride and Epinephrine Injection, USP) c) Lidocaine HCL 2% and Epinephrine 1:100,000 Injection (Lidocaine Hydrochloride and Epinephrine Injection, USP) d) Marcaine 0.5% (9 mg) with Epinephrine 1:200,000 Injection (Bupivacaine Hydrochloride and Epinephrine Injection, USP). -5- (Note: Product is labeled Cook-Waite (trademark) Marketed by Eastman Kodak Company, Dental Products, manufactured by Sanofi Winthrop, Inc., New York, New York.) Recall #D-230/233-7. CODE Lot numbers: a) C850RB EXP 2/99 and C520RA EXP 1/99; b) C860RB EXP 2/99; c) C545RB EXP 2/99, C565RA EXP 1/99, C570RB EXP 2/99; d) C565RB EXP 8/99. MANUFACTURER Sanofi Winthrop Pharmaceuticals, McPherson, Kansas (contract manufacturer) RECALLED BY Eastman Kodak Company, Rochester, New York, by letter dated April 30, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Puerto Rico. QUANTITY 35,390 cans were distributed. REASON Product packaged in cans without vacuum to assure potency throughout labeled expiration date. _______________ PRODUCT Petite Regime Sunscreen, SPF 30, OTC drug product. Recall #D-238-7. CODE Lot #4M28. MANUFACTURER Arizona Natural Resources, Inc., Phoenix, Arizona. RECALLED BY Gymboree Corporation, Burlingame, California, by letter on May 13, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide (Gymboree retail stores only). QUANTITY 3,725 units were distributed. REASON Product contamination with Pseudomonas putida. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT a) Red Blood Cells; (b) Fresh Frozen Plasma; c) Cryoprecipitate; d) Recovered Plasma. Recall #B-856/859-7. CODE All units collected from 9/1/91 to 11/20/96. MANUFACTURER New York Blood Services, also known as New York Blood Center, New York. RECALLED BY Manufacturer, by letters dated February 13 and 28, 1997, and June 16, 1997, and by letters dated February 10, 1997, and June 26, 1997. Firm-initiated recall ongoing. DISTRIBUTION New York, New Jersey, Switzerland. QUANTITY 5,000 units. REASON Blood products may have been improperly tested for viral markers between 09/1/91 and 11/20/96. -6-_______________ PRODUCT Red Blood Cells. Recall #B-886-7. CODE Unit #12GH67589. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter on May 7, 1997. Firm-initiated recall complete. DISTRIBUTION North Carolina QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. _______________ PRODUCT Platelets, Pheresis. Recall #B-887-7. CODE Unit numbers: 03P98568, 03LL08317, 03LL08316. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by letter dated December 2, 1996. Firm-initiated recall ongoing. DISTRIBUTION Georgia. QUANTITY 3 units were distributed. REASON Blood products have unacceptable platelet yields. _______________ PRODUCT a) Fresh Frozen Plasma; b) Cryoprecipitate; c) Recovered Plasma. Recall #B-1023/1025-7. CODE Units collected on 8/1/96. Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 594-1191 for individual unit numbers recalled. MANUFACTURER New York Blood Services, also known as New York Blood Center, New York, New York. RECALLED BY Manufacturer, by letters dated December 12,13, and 27, 1996. Firm-initiated recall ongoing. DISTRIBUTION New York, New Jersey, Switzerland. QUANTITY a) 77 units; b) 54 units; c) 53 units were distributed. REASON Blood products may been improperly tested (fixed plates) for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1). _______________ PRODUCT a) Fresh Frozen Plasma; b) Recovered Plasma. Recall #B-1052/1053-7. CODE a) 6710747 6710751 6710753 6710682 6710704 6710716 6710754 6710756 6710725 6710701 6710709 6710722 6710671 6710740 6710744 -7- 6710749 6710757 6710673 6710686 6710695 6710724 6710752 6710679 6710666 6710674 6710694 6710710 6710681 6710718 6710720 6710723 6710727 6710730 6710683 6710742 6710734 6710739 6710670 6710729 6710741 6710685 6710705 b) 6710743 6710746 6710748 6710755 6710693 6710668 6710672 6710675 6710678 6710680 6710687 6710688 6710689 6710690 6710731 6710696 6710702 6710703 6710707 6710713 6710714 6710715 6710717 6710721 6710733 6710737. MANUFACTURER New York Blood Services, also known as New York Blood Center, New York, New York. RECALLED BY Manufacturer, by letter dated February 12, 1997. Firm-initiated recall ongoing. DISTRIBUTION New York and Switzerland. QUANTITY a) 42 units; b) 26 units were distributed. REASON Blood products may have been improperly tested for the antigen to the human immunodeficiency virus type 1 (HIV-1p24 Antigen). _______________ PRODUCT a) Whole Blood; b) Red Blood Cells; c) Red Blood Cells, for further manufacture; d) Platelets, e) Platelets for further manufacture; f) Platelets, Pheresis; g) Fresh Frozen Plasma; h) Recovered Plasma. Recall #B-1054/1061-7. CODE Unit numbers: a) 26K82277 b) 26E01566 26G00559 26G58491 26G70525 26H07865 26H43359 26K23297 26K67090 26K93784 26K98422 26L32030 26L41998 26L56593 26L79027 26L90258 26M48006 26M48502 26R34426 c) 26K93451 26R83173 d) 26G00559 26G58491 26G70525 26H43359 26L56593 26L79027 26R83173 e) 26H07865 26K67090 26K93451 f) 26FL02704 g) 26H07865 26H43359 26H91001 26L79027 h) 26E01566 26G00559 26G70525 26K67090 26K93451 26K93784 26K98422 26L41998 26L56593 26L90258 26R34426 26K23297. MANUFACTURER American Red Cross Blood Services, Mobile, Alabama. -8-RECALLED BY Manufacturer, by letters between January 13, 1995 and March 6, 1996. Firm-initiated recall complete. DISTRIBUTION Alabama, Florida, Mississippi, California, Illinois, Massachusetts. QUANTITY a) 1 unit; b) 18 units; c) 2 units; d) 7 units; e) 3 units; f) 1 unit; g) 4 units; h) 12 units were distributed. REASON Blood products which 1) tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from donors who previously tested repeatedly reactive for anti-HIV-1; 2) tested initially reactive for anti-HIV-1 and repeat testing was not performed in accordance with the manufacturer's test kit instruction; 3) tested negative for the hepatitis B surface antigen (HBsAg), but were collected from a donor who previously tested repeatedly reactive for HBsAg; 4) tested negative for syphilis but collected from a donor who was confirmed positive for syphilis within the previous 5 months; 5) collected from a donor who reported a history of lung cancer; 6) had an unacceptable platelet count; or 7) were collected from a donor who reported a history of hepatitis. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1067/1068-7. CODE Unit #9331655. MANUFACTURER Florida Blood Services, Inc., St. Petersburg, Florida. RECALLED BY Manufacturer, by letter dated June 7, 1996. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit of each component was distributed. REASON Blood products tested repeatedly reactive for the Human Immunodeficiency virus type 1 (HIV-1)p24 antigen, neutralization negative. _______________ PRODUCT Platelets, Pheresis. Recall #B-1069-7. CODE Unit numbers 5043234 and 5043475. MANUFACTURER Lorain County Blood Bank, Inc., Elyria, Ohio. RECALLED BY Manufacturer, by telephone on May 27, 1997, followed by letter dated May 28, 1997. Firm-initiated recall complete. DISTRIBUTION Ohio and Kentucky. QUANTITY 2 units were distributed. REASON Blood products were incorrectly tested for the hepatitis B surface antigen (HBsAg). -9-_______________ PRODUCT Platelets. Recall #B-1074-7. CODE Unit #49F97629. MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma. RECALLED BY Manufacturer, by telephone on April 29, 1997, followed by letter on May 5, 1997. Firm-initiated recall complete. DISTRIBUTION Oklahoma. QUANTITY 1 unit was distributed. REASON Blood product corresponded to a unit of Red Blood Cells that was reported as clotted. _______________ PRODUCT Red Blood Cells. Recall #B-1075-7. CODE Unit #2028045. MANUFACTURER Lorain County Blood Bank, Inc., Elyria, Ohio. RECALLED BY Manufacturer, by telephone on May 30, 1996, followed by letter dated June 9, 1997. Firm-initiated recall ongoing. DISTRIBUTION Ohio. QUANTITY 1 unit was distributed. REASON Blood product was incorrectly tested for the antibody to the hepatitis B core antigen (anti-HBc). _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1085/1086-7. CODE Unit numbers: a) 12H93571 and 12GY02702; b) 12H93571. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated May 22, 1997. Firm-initiated recall complete. DISTRIBUTION North Carolina and Massachusetts. QUANTITY a) 2 units; b) 1 unit was distributed. REASON Blood products were collected from a donor with a history of cancer. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1088/1089-7. CODE Unit #21 Q56828. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter on May 12, 1997, and by fax on May 9, 1997. Firm-initiated recall complete. DISTRIBUTION Oregon and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of cancer. -11-_______________ PRODUCT Source Plasma. Recall #B-1095-7. CODE Unit numbers: 68297763, 68532031, 68534110, 68538651, 70200850, 70205428, 70207705, 70213027, 70214123, 70217988. MANUFACTURER Simi Biological Resources, Inc., Tacoma, Washington. RECALLED BY Manufacturer, by letter dated August 6, 1996. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 10 units were distributed. REASON Blood products were collected from a donor who had previously been deferred for testing positive for the hepatitis B surface antigen (HBsAg), or for a history of hepatitis. _______________ PRODUCT Source Plasma. Recall #B-1096-7. CODE Unit #G-56799-081. MANUFACTURER Alpha Therapeutic Corporation, Charlotte, North Carolina. RECALLED BY Alpha Therapeutic Corporation, Los Angeles, California on September 26, 1996. Firm-initiated recall complete. DISTRIBUTION Spain. QUANTITY 1 unit was distributed. REASON Blood product tested positive for syphilis by RPR. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall #B-888-7. CODE Unit numbers: 40GN69148, 40GV09750, 40GK14385, 40FR18017, 40FR18021, 40GN69164, 40GN69163, 40GW41905, 40GR34051, 40FR18009, 40GW41887, 40FY20488, 40FE45804, 40FR18036, 40FR18016, 40GS35986, 40GS35991. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by telephone on May 29, 1997, and by letter on June 9, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 17 units were distributed. REASON Red blood cells failed red cell recovery ratio. _______________ PRODUCT Recovered Plasma for further manufacture. Recall #B-1087-7. CODE Unit #12GY02702. -11-MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated May 22, 1997. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY Blood products were collected from a donor with a history of cancer. REASON Blood product was collected from a donor with a history of cancer. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Quidel QuickVue One-Step H. Pylori Test. Recall #Z-688-7. CODE Lot #C010 J07201. MANUFACTURER Quidel Corporation, San Diego, California. RECALLED BY Manufacturer, by telephone on March 26 and 30, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide, Finland, Egypt. QUANTITY 63 kits were distributed. REASON False positive readings can be obtained using finger stick whole blood specimens. _______________ PRODUCT Solar 7000/8000 Patient Monitors with Software Version 4A, used to display physiological data from modules which monitor the patient for ECG, blood pressure etc. Recall #Z-691-7. CODE Version 4A software, installed in Solar 7000/8000 Patient Monitors used with Solar ECG/12SL Modules. MANUFACTURER Marquette Electronics, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by letter dated July 7, 1997. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 780 Solar ECG/12SL Modules with Version 4A software were distributed. Only the Solar 7000/8000 Patient Monitors used with the Solar ECG/12SL Modules are affected, and the software in these monitors is to be replaced. Also, 83 Version 4A software upgrade kits for units at consignees were distributed. REASON A software defect is causing incorrect waveform data. _______________ PRODUCT OrthoFrame/Mayo Wrist Fixator, Part #01-014-008, an external fracture fixation device used for temporary use during fracture healing. Recall #Z-697-7. CODE Lot #1802971. -12-MANUFACTURER Orthologic, Phoenix, Arizona. RECALLED BY Manufacturer, by letter on April 24, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY 101 units were distributed. REASON The device, labeled as sterile, may not be sterile. _______________ PRODUCT Bovie Cords, used to connect insulated suction cautery tubes to the power generator: a) Catalog No. 50-7046, Bovie Cord for Suction Tube b) Catalog No. 50-7045, Insulated Suction Cautery Tube 22cm with thumb valve (including Bovie Cord) c) Catalog No. 50-7048, Insulated Suction Cautery Tube 50cm with thumb valve (including Bovie Cord). Recall #Z-746/748-7. CODE Date codes DD6, EE6 and FF6. MANUFACTURER Pilling Weck, Fort Washington, Pennsylvania. RECALLED BY Pilling Weck, Inc. (now Weck Closure Systems), Research Triangle Park, North Carolina, by letter on July 19, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY 152 products were distributed. REASON The green plastic cover on the connector of the Bovie Cord may slide down, exposing the metal connector, thereby allowing the user to experience shock or burn. _______________ PRODUCT Coleman Aspiration Needles, used for tissue removal: a) Catalog No. COL-ASPI, Coleman Aspiration Needle; b) Catalog No. COL-ASPB, Coleman Body Aspiration Needle. Recall #Z-749/750-7. CODE All units. MANUFACTURER Kolster Methods, Inc., Anaheim, California. RECALLED BY Byron Medical, Tucson, Arizona, by letter on or about June 20, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY a) 408 units; b) 39 units were distributed. REASON The cannula tip may separate from the cannula shaft during use. -13-RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT Stainless Steel CHS Keyed Lag Screw - Super: a) Part No. 1327-46-000 b) Part No. 1327-48-000 c) Part No. 1327-50-000 d) Part No. 1327-52-000 e) Part No. 1327-54-000 f) Part No. 1327-56-000 g) Part No. 1327-58-000 h) Part No. 1327-60-000 i) Part No. 1327-62-000. Recall #Z-728/736-7. CODE Lot numbers: a) QW235; b) QW236, QW377; c) QW237, QW378; d) QW238, QW379; e) QW239, QW478, QW519; f) QW240, QW381, QW479, QW529; g) QW241, QW382, QW480; h) QW242, QW383, QW481, QW522; i) QW243, QW384, QW523. MANUFACTURER Depuy Ace Medical Company, El Segundo, California. RECALLED BY Manufacturer, by telephone on April 14, 1997, followed by fax on April 17, 1997 and mailed on April 18, 1997. Firm-initiated recall ongoing. DISTRIBUTION California, Texas, Florida, Ohio, Virginia, Illinois. QUANTITY 306 pieces were distributed. REASON The 16mm head diameter screws are labeled as being 13mm head diameter screws. _______________ PRODUCT Polarus Cancellous Screw, fixation devices designed to provide secure fixation of various fractures while they heal: a) Part #HCA5300, 5.0 x 30.0mm Cancellous Screw b) Part #HCA5350, 5.0 x 35.0mm Cancellous Screw. Recall #Z-744/745-7. CODE Lot numbers: a) 2634-AA; b) 2634-AB. MANUFACTURER Acumed, Inc., Beaverton, Oregon. RECALLED BY Manufacturer, by telephone on or about June 22-23, 1997, followed by memorandum. Firm-initiated recall complete. DISTRIBUTION California, South Carolina, Arizona, Utah, Kansas, Missouri, Nevada, Georgia, Washington state, Mississippi, Minnesota, Michigan, Oregon. QUANTITY a) 145 units; b) 141 units were distributed -14-REASON Part #HCA5300, lot #2634-AB, screws are packaged, labeled, and laser-marked as part #HCA5350, lot #2634-AA, screws, and vice versa. -15- END OF ENFORCEMENT REPORT FOR JULY 30, 1997. 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