June 28, 2000 00-26RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT Bon Campo brand Sun Dried Tomatoes, packaged in 3-ounce (85g) clear plastic trays. Recall #F-503-0. CODE None. UPC 081517 100193 on the front label. All product on market at time of recall initiation. MANUFACTURER Merex Corporation, Yonkers, New York (repacker). RECALLED BY Repacker, by letter dated March 31, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 408 packages were distributed. REASON Product contained undeclared sulfites. ________ PRODUCT Tropical Mix (Trail Mix), in 4 and 16-ounce bags, and a 14-ounce plastic container, under The Farmers Market and Earth Delites label. Recall #F-553-0. CODE Best Before June 17 or earlier. MANUFACTURER Pittsburgh Snax and Nut Company, Pittsburgh, Pennsylvania. RECALLED BY Manufacturer, by telephone followed by press release on May 4, 2000. Firm-initiated field correction (relabeling) complete. DISTRIBUTION Pennsylvania and Ohio. QUANTITY Firm estimates none remain on market. REASON Product contains undeclared sulfites and FD&C Yellow No. 6. ________ PRODUCT Stop & Shop brand Vegetarian Vegetable Condensed Soup, in 10.75-ounce can. Recall #F-562-0. CODE Y246 9 257 K. MANUFACTURER Freddy's Products/Les Produits Freddy, Quebec, Canada. RECALLED BY Stop & Shop Supermarket Company, Boston, Massachusetts, by press release on May 11, 2000. Firm-initiated recall complete. DISTRIBUTION Connecticut and Massachusetts. QUANTITY 343 cases (24 cans/case) were distributed. REASON Product contains undeclared eggs. ________ PRODUCT Naturally Good Low Fat Caramel Corn, in 10-ounce containers. Recall #F-563-0. CODE Lot 42MAY22. MANUFACTURER Poppee's Popcorn, North Ridgeville, Ohio. RECALLED BY Snyder of Berlin, Berlin, Pennsylvania, by press release on April 20, 2000, and by letter on April 21, 2000. Firm-initiated recall complete. DISTRIBUTION Kentucky, Maryland, Ohio, Pennsylvania, Tennessee, Virginia, West Virginia. QUANTITY Firm estimates none remain on market. REASON Product contains undeclared peanuts. ________ PRODUCT Seagull brand Egg-Plant (whole) in brine, in 16-ounce glass jars. Recall #F-564-0. CODE None. All product on market at time of recall initiation. MANUFACTURER Savoy Enterprise, Ltd., Bangkok, Thailand. RECALLED BY Hong Thai Foods Corporation, Brooklyn, New York (importer), by letter and press release on January 27, 2000. Completed field correction (relabeling) resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, New Jersey, Pennsylvania, Massachusetts. QUANTITY 46 cases (24 jars per case) were distributed. REASON Product contained undeclared sulfites. ________ PRODUCT Smoked Salmon Pate in flexible retort pouches. Recall #F-566-0. CODE 110499, 120499, 2561006, 2561007, 2561027, 2561028, 2561029, 2561030, 2561046, 2561047, 2561063, 2561064, 2561085, 2561086, 2561097, 2561098, 2561129, 2561130. MANUFACTURER Northwest Gourmet, Dundee, Oregon. RECALLED BY Manufacturer, by telephone on April 14, 2000, followed by letter on April 20, 2000, and by press release on April 18, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 10,994 pieces were distributed. REASON Product contains undeclared egg yolks.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Yogurt Trail Mix, in 4 and 16-ounce bags, and in a 14-ounce plastic container, under the Farmers Market and Earth Delites labels. Recall #F-554-0. CODE Best Before June 17 or earlier. MANUFACTURER Pittsburgh Snax and Nut Company, Pittsburgh, Pennsylvania. RECALLED BY Manufacturer, by telephone followed by press release on May 4, 2000. Firm-initiated field correction (relabeling) ongoing. DISTRIBUTION Pennsylvania and Ohio. QUANTITY Firm estimates none remain on market. REASON Product contains undeclared sulfites and FD&C Yellow No. 6. _______ PRODUCT Chocolate Chip/Baking Chip products: 1) Tropical Source Semi-Sweet Dairy Free Chocolate Chips (Baking Chips), 10-ounce bag, sku #01281 2) Tropical Source Espresso Roast Dairy Free Chocolate Chips (Baking Chips), 10-ounce bag, sku #01283 3) Cloud Nine Pure Chocolates Dairy Free Baking Chips a) 10-pound box, sku #09006 b) 25-pound box, sku #09003 4) Tropical Source Bulk Espresso Baking Chips, 25-pound box, sku #01433 5) Tropical Source Baking Chip Floor Shipper Display, 48/10-ounce bags, sku #01289. Recall #F-555/559-0. CODE All 1999 product produced by the manufacturer (Kargher). The manufacturer used the following coding system, which is stamped in black ink on the 10-ounce bags only: For example: 277K91H = 277 = day of the year, K = Kargher, 9 = year (1999) 1 = packaging shift, and H = production line. The 10-pound and 25-pound bulk carton is coded as follows: For example: 910111, 9 = year, 10 = month, 11 = day, and the 1 = the number of the batches made of that product on that day. MANUFACTURER Kargher Chocolate Company, Hatfield, Pennsylvania. RECALLED BY Cloud Nine, Inc., Hoboken, New Jersey, by fax on March 1 and 2, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY Amount Shipped - United States: 1) 2,675 cases x 6 boxes x 12/10-oz. units 2) 872 cases x 6 boxes x 12 10-oz. units; 3) (a) 989 bulk cases; b) 3,465 25-lb. bulk cases; 4) 354 25-lb. bulk cases; 5) 336 x 48 10-oz. packages (floor display shipper) Amount Shipped - Canada 1) 151 cases x 6 boxes x 12 10-oz. units 2) 30 cases x 6 boxes x 12-10-oz. units 3) (a) 281 10-lb. Cases (bulk); (b) 31 25-pound cases (bulk); 4) 0; 5) 0. REASON Products may be contaminated with milk protein. ________ PRODUCT Lipton Noodles and Sauce, Butter, Egg Noodles in a Butter Sauce, in 4.5-ounce foil pouch. Recall #F-552-0. CODE Lot OB02L***, where the last three digits vary. MANUFACTURER Customized Solutions, LLC, Montgomery, Illinois. RECALLED BY Lipton, Englewood Cliffs, New Jersey, by "Product Retrieval Notice" dated February 17, 2000. Firm-initiated recall complete. DISTRIBUTION Northeastern United States. QUANTITY 1,200 pouches were distributed. REASON Product was manufactured using onion powder found to be contaminated with Salmonella cerro.RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
________ PRODUCT Ardmore Farms brand 100% Pure Apple Juice, in 4-ounce cups, 96 cups per case. Recall #F-561-0. CODE N1370B2, N1380B3 and N1380B1 on shipping case. MANUFACTURER Country Pure Foods, Inc., Akron, Ohio. RECALLED BY Manufacturer, by telephone, fax, and mail on May 25, 2000. Firm-initiated recall complete. DISTRIBUTION West Virginia, Minnesota, California, New York, Indiana, Washington state, Tennessee, Ohio. QUANTITY 1,627 cases (156,192 individual cups) were distributed. REASON Products are contaminated with yeast. ________ PRODUCT 1) Caffeine Free Diet Dr. Pepper a) labeled as "CANNED BY GULF STATE CANNERS, INC., CLINTON, MISSISSIPPI" bearing the following "sell by" dates: MAY0800, MAY1500, MAY2200, JUN0500, JUN1900, JUN2600 b) labeled as "CANNED BY BATON ROUGE COCA-COLA BOTTLING CO., BATON ROUGE, LOUISIANA" bearing the following "sell by" dates MAY0100, MAY1500, MAY2900, JUN1200,JUN2600 2) Caffeine Free Dr. Pepper labeled as "CANNED BY BATON ROUGE COCA-COLA BOTTLING CO., BATON ROUGE, LOUISIANA" bearing the following "sell by" dates: NOV2000, DEC1100, DEC1800. Recall #F-571/572-0. CODE 1 (a) "Sell by" dates: MAY0800, MAY1500, MAY2200, JUN0500, JUN1900, JUN2600 (b) "Sell by" dates: MAY0100, MAY1500, MAY2900, JUN1200,JUN2600 2) "Sell by" dates: NOV2000, DEC1100, DEC1800. MANUFACTURER Gulf States Canners, Inc., Clinton, Mississippi and Baton Rouge Coca-Cola Bottling Company. Baton Rouge, Louisiana. RECALLED BY Dr. Pepper/Seven Up, Inc., Plano, Texas, by telephone on April 7, 2000, followed by letter dated April 13, 2000. Firm-initiated recall complete. DISTRIBUTION Kentucky, Mississippi, Arkansas, Louisiana, Tennessee. QUANTITY 6,890 6-packs and 33,040 12-packs were distributed. REASON Product contains 55 mg sodium but lists 0 mg sodium on the label.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT a) UriTAB(tm) Caplets (Phenazopyridine HCL 95 mg), 30 caplet box, OTC, for urinary pain relief; b) PremeTAB(tm) Tablets (Acetaminophen 500 mg, Pamabrom 25mg, Pyrilamine Maleate 15 mg) 15 tablet units, OTC, for use I n premenstrual discomfort; c) PrevenTAC(tm) Caplets (Aspirin 81 mg), 30 caplets, OTC, to help in the prevention of heart disease and heart attacks; d) SomaTAC(tm) Caplets (Diphenhydramine Hydrochloride 50 mg), 15 caplets, OTC, helps relieve occasional sleeplessness due to stress, anxiety, restlessness, and irritability. Recall #D-413/416-0. CODE a) Lot #J15460; b) Lot #J15466; c) Lot #J16148; d) Lot #J15548. MANUFACTURER Formulex Canada, Inc., Villemont-Royal, Quebec, Canada (contract manufacturer). RECALLED BY Olus Laboratories, Farmingdale, New York (responsible firm), by fax on February 21, 2000, and by telephone on March 22, 2000. Firm-initiated recall ongoing. DISTRIBUTION a) Connecticut, New Jersey, Oregon; b) Connecticut, New Jersey, New York, Oregon; c) Connecticut, Florida, Georgia, New Jersey, New York, North Carolina, Oregon, Pennsylvania, Texas; d) Connecticut, New Jersey, Oregon. QUANTITY a) 77 cases, 24 blister packs of 30 caplets each per case; b) 89 cases, 24 blister packs of 15 tablets each per case; c) 593 cases, 24 blister packs of 30 caplets each per case; d) 97 cases, 24 blister packs of 15 caplets each per case were distributed. REASON Products are unapproved new drugs.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT a) Glyburide Tablets (micronized), USP, 1.5 mg, 100 tablets, unit dose, Rx; b) Glyburide Tablets (micronized), USP, 3 mg, 100 tablets, unit dose,. Products are indicated as an adjunct to diet to lower the blood glucose I n patients with non-insulin dependent diabetes mellitus (type II) whose hyperglycemia cannot be satisfactorily controlled alone. NDC Numbers: 55953-034-41 and 55953-035-41. Recall #D-411/412-0. CODE Lot Numbers: a) 114058B EXP 10/00, 114059B EXP 10/00, 114060B EXP 10/00, and 116884A EXP 4/01; b) 114061D EXP 4/01, 114062D EXP 4/01, 114063D EXP 4/01, 114517B EXP 5/01, and 116893A EXP 12/01.MANUFACTURER
Novopharm, Ltd., Toronto, Canada. RECALLED BY Teva Pharmaceuticals USA, Sellersville, Pennsylvania, by letter on June 5, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 1,386 units were distributed; firm estimated that 5 percent of product remained on market at time of recall initiation. REASON Impurity failure (12 month stability testing).RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT Platelets, Pheresis. Recall #B-827-0. CODE Unit Numbers: 8080857 and 8092579 (split products). MANUFACTURER LifeShare, Inc., Elyria, Ohio. RECALLED BY Manufacturer, by telephone on March 15, 2000, followed by letter dated April 20, 2000. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 2 split units were distributed. REASON Blood products were labeled with extended expiration dates. ________ PRODUCT Platelets, Pheresis - Volume-Reduced. Recall #B-828-0. CODE Unit #17FX21187. MANUFACTURER American Red Cross Blood Services, Green Bay, Wisconsin. RECALLED BY American Red Cross Blood Services, Madison, Wisconsin, by letter dated J January 27, 1999. Firm-initiated recall complete. DISTRIBUTION Wisconsin. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. ________ PRODUCT Red Blood Cells. Recall #B-836-0. CODE Unit 21KR06899. MANUFACTURER American Red Cross Blood Service, Pacific Northwest Regional Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter dated March 10, 2000. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor taking the drug Methotrexate. ________ PRODUCT Red Blood Cells. Recall #B-837-0. CODE Unit #7618476. MANUFACTURER Carter BloodCare, Bedford, Texas. RECALLED BY Manufacturer, by telephone on July 21, 1999. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was positive for Jka antigen, was distributed labeled as Jka negative. ________ PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c) Recovered Plasma. Recall #B-838/840-0. CODE Unit #21KG23428. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by telephone on February 3, 2000, and by letter dated February 9, 2000. Firm-initiated recall complete. DISTRIBUTION Arizona, Washington state, Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of jaundice. ________ PRODUCT Platelets, Pheresis. Recall #B-841-0. CODE Unit Numbers: 0335580A and 0335580B. MANUFACTURER Inland Northwest Blood Center, Spokane, Washington. RECALLED BY Manufacturer, by telephone on February 18, 2000, followed by letter dated March 28, 2000. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY 1 unit was distributed. REASON Blood products were labeled with incorrect platelet yields. ________ PRODUCT Source Plasma. Recall #B-842-0. CODE Unit Numbers: 98560684 and 98668816. MANUFACTURER Interstate Blood Bank Incorporated of Wisconsin, Milwaukee, Wisconsin. RECALLED BY Interstate Blood Bank, Inc., Memphis, Tennessee, by fax on May 21, 1998. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor who was not properly screened.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-789/791-0. CODE Unit Numbers: a) 8636407, 8695147, 875070 b) 8636407, 8695147; c) 8636407, 8695147. MANUFACTURER The Blood Center, New Orleans, Louisiana. RECALLED BY Manufacturer, by letter dated September 1, 1998. Firm-initiated recall complete. DISTRIBUTION Louisiana and New Jersey. QUANTITY a) 3 units; b) 2 units; c) 2 units were distributed. REASON Blood products were collected from a donor with a history of Idiopathic Thrombocytopenic Purpura. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-797/798-0. CODE Unit Numbers: a) 42Q66663; b) 42G26813, 42G26819, 42G26823, 42Q66652, 42Q66662 42Q66663, 42Q66664, 42Q66665, 42Q66666. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by telephone on February 23, 2000, and by letters dated February 24, 2000. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY a) 1 unit; b) 9 units were distributed. REASON Blood products were collected in expired blood collection bags. ________ PRODUCT Red Blood Cells. Recall #B-829-0. CODE Unit #32GK75466. MANUFACTURER American Red Cross Blood Services, Green Bay, Wisconsin. RECALLED BY American Red Cross Blood Services, Madison, Wisconsin, by telephone on August 19, 1998. Firm-initiated recall complete. DISTRIBUTION Wisconsin. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose arm inspection and skin disease status had not been documented.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT MemoryLens Ultraviolet-Absorbing, Hydrophilic, Posterior Chamber Lens: a) Model No. U940A, MemoryLens Ultraviolet-Absorbing, Hydrophilic, Posterior Chamber Intraocular; b) Model No. U940S, MemoryLens Ultraviolet-Absorbing, Hydrophilic, Posterior Chamber Intraocular Lens. Recall #Z-741/742-0. CODE All Lot Numbers manufactured on or before 3/24/2000. MANUFACTURER Ciba Vision Corporation, Duluth, Georgia. RECALLED BY Manufacturer, by letter dated April 10, 2000. Firm-initiated recall ongoing. QUANTITY 263,000 units were distributed. REASON Implantation of this lens may cause postoperative inflammation. ________ PRODUCT T-9 Scoop Transtracheal Procedure Tray. Recall #Z-743-0. CODE Lot Numbers: 0339, 1409, 2749. MANUFACTURER Transtracheal Systems, Englewood, Colorado. RECALLED BY Manufacturer, by mail on June 9, 2000, followed by telephone. Firm-initiated recall ongoing. COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Nationwide and international. QUANTITY 643 trays. REASON Trays contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility. ________ PRODUCT SYSMEX CA-1000 and SYSMEX CA-5000 Automated Coagulation Analyzer, used to the clotting times of heparinized patients to adjust their heparin treatment. Recall #Z-754/755-0. CODE All serial numbers. MANUFACTURER Sysmex Corporation of America, Long Grove, Illinois. RECALLED BY Manufacturer, by letter dated April 26, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 1,405 CA-1000 analyzers and 132 CA-5000 analyzers were distributed. REASON Incorrect aPTT (activated partial thromboplastin time) analysis of patient Samples which contain elevated levels of fibrinogen or fibrinogen-related products which are not measured by aPTT (fibrinogen monomer) could occur. ________ PRODUCT Walkmed Administration Sets for WalkMed Infusion Pumps: a) Catalog #PS-400/300; b) Catalog #EFV-101S; c) Catalog #EFV-101B; d) Catalog #FPS-560. Recall #Z-756/759-0. CODE Lot Numbers: a) Lot 9I112, 9I113, 9J115, 9K103; b) D991020-B; c) D991027-A; d) D991202-A. MANUFACTURER McKinley Medical, LLLP, Wheat Ridge, Colorado. RECALLED BY Manufacturer, by mail on May 5, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 41,720 sets were distributed. REASON Defective plastic elbow connector could allow leak or air introduction. ________ PRODUCT Curity Spinal Anesthesia Tray; Safe Tap Spinal Anesthesia Tray; Spinal Anesthesia; Saddle Block and Customer Special Spinal Tray. Recall #Z- 766/770-0. CODE Note: This recall only applies to alpha numeric lot numbers beginning with "FE83", "HE83", "JE83" and "GE83"; numerical lot numbers beginning with "0", "4", "5" and "9". Part # Description 470 CURITY Spinal Anesthesia Tray 4716 CURITY Spinal Anesthesia Tray 4720 CURITY Spinal Anesthesia Tray 4722 CURITY Spinal Anesthesia Tray 4724 CURITY Spinal Anesthesia Tray 4727 CURITY Spinal Anesthesia Tray 4730 CURITY Spinal Anesthesia Tray 4731 CURITY Spinal Anesthesia Tray 4747 Safe Tap Spinal Anesthesia Tray 4748 Safe Tap Spinal Anesthesia Tray 4749 Safe Tap Spinal Anesthesia Tray 4760 CURITY Spinal Anesthesia Tray/Saddle Block 4761 CURITY Spinal Anesthesia Tray 4762 CURITY Spinal Anesthesia Tray 4763 CURITY Spinal Anesthesia Tray/Saddle Block 4764 CURITY Spinal Anesthesia Tray/Saddle Block 4765 CURITY Spinal Anesthesia Tray 4766 CURITY Spinal Anesthesia Tray 4767 CURITY Spinal Anesthesia Tray/Saddle Block 4768 CURITY Spinal Anesthesia Tray 4769 CURITY Spinal Anesthesia Tray 4770 CURITY Spinal Anesthesia Tray 4787 CURITY Spinal Anesthesia Tray/Saddle Block 4795 CURITY Spinal Anesthesia Tray/Saddle Block 4815 CURITY Spinal Anesthesia Tray 4920 CURITY Spinal Anesthesia Tray 5171 Continuous Epidural Anesthesia Tray 10569 Customer Special: Spinal Tray 10584 Customer Special: Spinal Tray 10590 Customer Special: Spinal Tray 10614 Customer Special: Spinal Tray 10616 Customer Special: Spinal Tray 10617 Customer Special: Spinal Tray 10618 Customer Special: Spinal Tray 10641 Customer Special: Spinal Tray 10702 Customer Special: Spinal Tray 10705 Customer Special: Spinal Tray 10708 Customer Special: Spinal Tray 472867 Customer Special: Spinal Tray 476827 Customer Special: Spinal Tray. MANUFACTURER The Kendall Company LP, Mansfield, Massachusetts. RECALLED BY Manufacturer, by mail on May 10, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Japan, Panama, Bahamas, Saudi Arabia. QUANTITY Approximately 14,570 cases. REASON Spinal anesthesia trays contain recalled Epinephrine Injection USP, 1 ml ampule. ________ PRODUCT Vasoview Dissection/Vessel Harvesting System: a) VasoView, Part #09331; b) Vasoview Uniport, Part #11344; c) Vasoview Uniport Plus, Part #11346. The VasoView Uniport dissection cannula has applications in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting surgery for arterial bypass. Recall #Z- 771/773-0. CODE All codes. MANUFACTURER Guidant Corporation, Menlo Park, California. RECALLED BY Manufacturer, by letter on May 11, 2000, followed by telephone. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 5,730 units were distributed. REASON Sterility may be compromised as evidenced by a loss of package integrity. ________ PRODUCT Version 6A and prior versions of software for Marquette Coherent Digital Telemetry (CDT) LAN Monitoring Systems, a patient monitoring system designed to collect and transmit ECG and other physiological data from ambulatory patients, without the patient being physically connected to a display device. Recall #Z-774-0. CODE All versions of the software used with CDT LAN Monitoring Systems. MANUFACTURER GE Marquette Medical Systems, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by issuing an Urgent Patient Alarm Safety Alert dated May 3, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 2,254 units were distributed. REASON Due to a software defect, there could be alarm failure. ________ PRODUCT Fixer Image Scan Editing Utility, Version 3.0, intended to allow the user to remove suprious image slices from a scan. Recall #Z-784-0. CODE Fixer Software Utility Version 3.0 MANUFACTURER Radionics, Inc., Burlington, Massachusetts. RECALLED BY Manufacturer, by telephone on March 9, 2000, followed by letter. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 33 installed bases. REASON Fixer 3.0 may provide inconsistent results if a file is changed and saved twice in the same session. ________ PRODUCT Sarita and Sarita 160 Patient Lift, Non-AC Powered Lift/Transfer System used to transfer patients/residents between beds, chairs and toilets: a) Model KKA0400; b) KKA0420-16; c) KKA0401; d) KKB3000-11US; e) KKB3020-16US. Recall #Z-785/789-0. CODE All serial numbers prior to 4899 834795-011 Model KKB3000-11US - Sarita; Model KKB3020-16US - Sarita 160. MANUFACTURER Arjo, Inc., Roselle, Illinois. RECALLED BY Manufacturer, by letter dated May 11 and 30, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY 967 units were distributed. REASON Premature cracking of foot support platform of the lift. ________ PRODUCT Maxilift Patient Lift, Non-AC powered, used to move patients in a nursing home situation. Recall #Z-790-0. CODE All serial numbers preceding week 1/95, with serial number prefixes preceding US0195, SE0195, GB0195, and include serial numbers beginning with 93MM, 93ME, 94MM and 94ME. Model 211026, Maxilift Manual Chassis with Scale Model 212624, Maxilift Manual Chassis - Beige Model 210024-06, Maxi Scale Std - Beige Model 212000-06, Maxi Pillar Beige Model KMB0810-06US, Maxilift Combi Model KMB0830-06US, Maxilift Combi with Scale Model KMB2351, Maxilift Electric with Scale Model MA0500, Maxi Pillar Model MA0510, Maxi Mast for Electric Chassis Model MB0500, Maxilift Beige Model MB0510, Maxilift with Battery Powered Chassis Model MB0600, Maxilift with Scale - Beige Model MB0610, Maxilift Battery Powered with Scale. MANUFACTURER Arjo, Inc., Roselle, Illinois. RECALLED BY Manufacturer, by letters dated May 11 and 30, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY 1,017 units were distributed. REASON Spring (roll) pin subject to shear in Maxilifts greater than 5 years old. ________ PRODUCT Maximove Patient Lift, Non-AC powered, used to move patients in a nursing home situation: Models KRA0300, MA0510, KMA1004, KMB0810-06, KMB0830-06, KMB4500-12US, KMB6950-12US, KMB6970-12US, KMB6980-12US. Recall #Z-791/799-0. CODE Maximove models KRA0300 (mast Model), KMB4500-12US, KMB6950-12US, KMB6970-12US, KMB6980-12US, serial numbers GB 2097 784578 001 through GB 0899 819426 006; weeks 20/97 through 08/99 Model KMB4500-12US - Maximove with powered V chassis Model KMB6950-12US - Maximove with powered parallel chassis & scale Model KMB6970-12US - Maximove with powered parallel chassis Model KMB6980-12US - Maximove with powered V chassis & scale Maximove Combi models KRA0300 (Mast model) and KMA1004, serial numbers start with GB or SE; weeks 03/96 through 05/99 Model KMA1004 - Maximove Combi Lift Arm Assembly Maxilift Combi models MA0510 (Mast Model), KMB0810-06, KMB0830-06, serial numbers GB 0596 770428 003 through GB 3496 773176 010; weeks 05/96 through 34/96 Model KMB0810-06US, Maxilift Combi Model KMB0830-06US, Maxilift Combi with Scale. MANUFACTURER Arjo Inc., Roselle, Illinois. RECALLED BY Manufacturer, by letters dated may 11 and 30, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY 1,465 units were distributed. REASON Over depression of the locking spring pin results in the lift arm not locking. _________ PRODUCT Marisa Patient Lift, Non-AC Powered, used to move weak or highly dependent patients in a nursing home situation: a) Model KGB2000-US, Marisa Complete with Jib, but no Scale; b) Model KGB2100-US, Marisa Complete with Jib and with Scale ; c) Model KGA0200. Recall #Z-800/802-0. CODE All serial numbers below GB 3298 807390 002. MANUFACURER Arjo, Inc., Roselle, Illinois. RECALLED BY Manufacturer, by letters dated May 11 and 30, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY 1,331 lifts were distributed. REASON Jib assembly plunger may not fully engage in the carriage receptacle.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT Vitros Cardiology Controls (human serum), for in-vitro diagnostic use only, Catalog #865 0939. Recall #Z-753-0. CODE Lot number 50. MANUFACTURER Ortho-Clinical Diagnostics, Inc., Rochester, New York. RECALLED BY Manufacturer, by letters on July 14, 1999, and August 12, 1999. Firm- initiated recall complete. DISTRIBUTION California, District of Columbia, Illinois, Indiana, Montana, Nevada, Ohio, New York, South Carolina, Texas, Virginia, Wisconsin, Australia, Brazil, Canada, Singapore, England and France. QUANTITY 338 packs were distributed. REASON Cardiology controls gave low values approximately 2 standard deviations below target values. ________ PRODUCT Cemented Hip Stem, Catalog #6098-0940. Recall #Z-760-0. CODE Case Code: 46364801 Serial Numbers: 20458S, 20459D, 20461S, 20462S, 20463S, and 38086P. MANUFACTURER Stryker Howmedica Osteonics, Allendale, New Jersey. RECALLED BY Manufacturer, by telephone on March 21, 2000. Firm-initiated recall ongoing. DISTRIBUTION Illinois, Minnesota, Oklahoma and Canada. QUANTITY 5 units were distributed. REASON Mislabeling - The device is labeled having a 127 degree neck angle when in fact the hip stem actually have a 132 degree neck angle. ________ PRODUCT IMx hCG Calibrators, for in Vitro Diagnostic use. The Imx hCG Calibrators are for the calibration of the Imx Anallyzer when used for the quantitative/qualitative determination of human chorionic gonadotropin (hCG) for the early detection of pregnancy. Recall #Z-761-0. CODE List #3A63-01, Lot #55552Q100 EXP 5/13/00. MANUFACTURER Abbott Health Products, Inc., Barceloneta, Puerto Rico. RECALLED BY Manufacturer, by telephone or fax on April 27, 2000, and by letter dated April 26, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Australia, Canada, Germany, Italy, Japan, and Mexico. QUANTITY 234 kits were distributed. REASON The IMx hCG Calibrator lot 55552Q100 rates have decreased over time which may result in elevated control values. ________ PRODUCT Pentalumen Thermodilution Catheter, Heparin Coated, Flow-Directed Thermodilution Pulmonary Artery Catheder, Rx device for rapid and accurate measurement of hemodynamic pressure and determination of cardiac output using a cardiac output computer. Z-762-0. CODE List #412320401, Lot #59-249-SN. MANUFACTURER Abbott Laboratories, Hospital Products Division, Abbott Park, Illinois. RECALLED BY Manufacturer, by letter dated May 10, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Canada, Chile. QUANTITY 960 catheters were distributed. REASON One or more of the lumens in the catheter may be occluded. ________ PRODUCT Genesis II and Profix Porous Femoral Components, sterile product, packaged one per container for use by an orthopaedic surgeon: Z-763-0 - Genesis II Femoral Components: Description Part Number Lot Sz 3 LT 71420036 00111302 Sz 4 LT 71420038 91106643 Sz 5 LT 71420040 00111462 Sz 5 LT 71420040 00111463 Sz 5 LT 71420040 00304339 Sz 5 LT 71420040 00304340 Sz 6 LT 71420042 91103882 Sz 6 LT 71420042 91103883 Sz 6 LT 71420042 91107062 Sz 6 LT 71420042 91107063 Sz 6 LT 71420042 91107064 Sz 6 LT 71420042 00101454 Sz 6 LT 71420042 00101457 Sz 7 LT 71420044 00206821 Sz 7 LT 71420044 00206822 Sz 4 RT 71420054 91201372 Sz 4 RT 71420054 91201373 Sz 4 RT 71420054 91201371 Sz 4 RT 71420054 91204594 Sz 4 RT 71420054 00101463 Sz 4 RT 71420054 00101464 Sz 4 RT 71420054 00111306 Sz 4 RT 71420054 00111307 Sz 4 RT 71420054 00111308 Sz 5 RT 71420056 91107068 Sz 5 RT 71420056 91107069 Sz 5 RT 71420056 91107070 Sz 5 RT 71420056 91106158 Sz 5 RT 71420056 90016159 Sz 5 RT 71420056 91106160 Sz 5 RT 71420056 91107067 Sz 5 RT 71420056 00111304 Sz 5 RT 71420056 00111304A Sz 5 RT 71420056 00404566 Sz 5 RT 71420056 00404567 Sz 5 RT 71420056 00404563 Sz 5 RT 71420056 00404564 Sz 5 RT 71420056 00404565 Sz 7 RT 71420060 91204591 Sz 7 RT 71420060 91204592 Sz 7 RT 71420060 00206823 Sz 7 RT 71420060 00206824 Sz 7 RT 71420060 00406018 Sz 7 RT 71420060 00406017 Sz 7 RT 71420060 00103496 Z-764-0 - Profix Femoral Components: Description Part Number Lot Sz 3 RT 71502130 00105665 Sz 4 RT 71502140 91100703 Sz 4 RT 71502150 91100704 Sz 4 RT 71502140 91107043 Sz 4 RT 71502150 91107044 Sz 4 RT 71502140 91107045 Sz 4 RT 71502150 91203073 Sz 5 RT 71502150 91101207 Sz 5 RT 71502150 91106635 Sz 5 RT 71502150 91106636 Sz 5 RT 71502150 91106146 Sz 5 RT 71502150 91106147 Sz 5 RT 71502150 91106634 Sz 5 RT 71502150 91107801 Sz 5 RT 71502150 91107802 Sz 5 RT 71502150 91107724 Sz 5 RT 71502150 91107725 Sz 5 RT 71502150 91107803 Sz 5 RT 71502150 91200417 Sz 5 RT 71502150 91200418 Sz 5 RT 71502150 91100419 Sz 5 RT 71502150 91200420 Sz 5 RT 71502150 92100416 Sz 6 RT 71502160 91101209 Sz 6 RT 71502160 91107805 Sz 6 RT 71502160 91107806 Sz 6 RT 71502160 91100706 Sz 6 RT 71502160 00209183 Sz 6 RT 71502160 00209184 Sz 6 RT 71502160 00301458 Sz 6 RT 71502160 00301457 Sz 6 RT 71502160 00301456 Sz 6 RT 71502160 00305645 Sz 2 LT 71502220 00405819 Sz 2 LT 71502220 91203766 Sz 2 LT 71502220 91204891 Sz 3 LT 71502230 91106628 Sz 3 LT 71500230 91106629 Sz 3 LT 71502230 91106630 Sz 3 LT 71500230 91106149 Sz 3 LT 71502230 91106150 Sz 3 LT 71500230 00109524 Sz 4 LT 71590001 91203525 Sz 4 LT 71590001 91203526 Sz 4 LT 71502240 91101931 Sz 4 LT 71502240 91101932 Sz 4 LT 71502240 91101933 Sz 4 LT 71502240 00104672 Sz 4 LT 71502240 00109525 Sz 4 LT 71502240 00301453 Sz 4 LT 71502240 00301454 Sz 4 LT 71502240 00310670 Sz 5 LT 71502250 91102580 Sz 5 LT 71502250 91102582 Sz 5 LT 71502250 91109920 Sz 5 LT 71502250 91109921 Sz 5 LT 71502250 91110383 Sz 5 LT 71502250 91204253 Sz 5 LT 71502250 91204254 Sz 5 LT 71502250 00109527 Sz 5 LT 71502250 00109528 Sz 5 LT 71502250 00111459 Sz 5 LT 71502250 00111461 Sz 5 LT 71502250 00200116 Sz 5 LT 71502250 00200337 Sz 5 LT 71502250 00200338 Sz 5 LT 71502250 00200339 Sz 6 LT 71502260 91107049 Sz 6 LT 71502260 91107050 Sz 6 LT 71502260 91107051 Sz 6 LT 71502260 00104674 Sz 6 LT 71502260 91108859 Sz 7 LT 71502270 91106148 Sz 7 LT 71502270 91200414 Sz 7 LT 71502270 00111298. MANUFACTURER Smith and Nephew, Inc., Orthopaedic Division, Memphis, Tennessee. RECALLED BY Manufacturer, by letters on May 19 and 26, 2000, and by fax on May 20, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 945 units were distributed. REASON The bead sintering process temperature was insufficient for proper bead/substrate adhesion. _______ PRODUCT FreshLook Toric Soft Hydrophilic Contact Lenses for Astigmatism. Recall #Z-765-0. CODE Lot numbers: 101297 EXP 2003-01, 101296, EXP 2003-01. MANUFACTURER Wesley Jessen Corporation, Des Plaines, Illinois. RECALLED BY Manufacturer, by letters dated May 12, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 564 single blister trials and 246 6-packs were distributed. REASON Mislabeled for corrective power, cylinder and axis. ________ PRODUCT Cordis Smart Nitinol Stent Transhepatic Biliary System. Recall #Z- 775/776-0. CODE Catalog number 1440BB, Lot number X0200019; Catalog number 1420BB, Lot number 40200246. MANUFACTURER Cordis Corporation, Miami Lakes, Florida. RECALLED BY Manufacturer, by letter on April 25, 2000. Firm-initiated recall ongoing. DISTRIBUTION Tennessee, West Virginia, California, Louisiana, and Florida. QUANTITY 12 units were distributed. REASON Mislabeled guidewire size and mislabeled indication for use. ________ PRODUCT Cardiology Controls (human serum), for in vitro diagnostic use only. Recall #Z-803-0. CODE Lot #53 EXP 12/99. MANUFACTURER Ortho-Clinical Diagnostics, Inc., Rochester, New York. RECALLED BY Manufacturer, by letter dated November 23, 1999. Firm-initiated recall complete. DISTRIBUTION Alaska, California, Delaware, Indiana, Kansas, Kentucky, New York, Ohio, Oklahoma, Pennsylvania, Wisconsin, Canada, Belgium, and Germany. QUANTITY 33 packs were distributed. REASON Cardiology Controls gave low values approximately 2 standard deviations below target. ________ PRODUCT Lactate Membrane Kit Stat Profile M Series, for use with the Stat Profile M Analyzer. The Stat M. Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care usage in the quantitative determination of sodium, potassium, ionized calcium, ionized magnesium, glucose, lactate, and BUN in serum, plasma, and whole blood to evaluate the acid-base status of patients suspected of having lactic acidosis. Recall #Z-817-0. CODE Lot numbers: 901129 and 801129. MANUFACTURER Nova Biomedical Corporation, Waltham, Massachusetts. RECALLED BY Manufacturer, by telephone on March 8, 2000. Firm-initiated recall ongoing. DISTRIBUTION Arizona, Massachusetts, Florida, Wisconsin and Germany. QUANTITY 41 kits (6 membranes/kit) were distributed. REASON Extended expiration date.END OF ENFORCEMENT REPORT FOR JUNE 28, 2000.
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