April 19, 2000 00-16RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______ PRODUCT Royal Baltic brand Siomga, Captain, Trout (assorted cold smoked, sliced fish), packaged in 16-ounce clear cello packages. Recall #F-280-0. CODE 324 MANUFACTURER Royal Baltic Ltd., Brooklyn, New York. RECALLED BY Manufacturer, by letter on December 3, 1999. Firm-initiated recall complete. DISTRIBUTION Canada. QUANTITY 13 cases (163 units per case) were distributed. REASON Product was contaminated with Listeria monocytogenes. ________ PRODUCT Royal Baltic brand Siomga Captain, Trout (assorted cold smoked sliced fish), packaged in 8-ounce clear cello packages. Recall #F-281-0. CODE 275, designating it was manufactured on 5/27/99. MANUFACTURER Royal Baltic, Ltd., Brooklyn, New York. RECALLED BY Manufacturer, by press release on November 17, 1999, followed by letter. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, New Jersey, North Carolina. QUANTITY 277 packages were distributed. REASON Product was contaminated with Listeria monocytogenes.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Breaded Vegetable and Seafood Products: Blue Diamond Breaded Onion Rings (Regular). Blue Diamond Breaded Onion Rings (Gourmet). Blue Diamond Breaded Mozzarella Sticks (Regular). Blue Diamond Breaded Mozzarella Sticks (Fire). Blue Diamond Breaded Zucchini Slices. Blue Diamond Breaded Zucchini Sticks. Blue Diamond Breaded Mushrooms. Blue Diamond Breaded Mushrooms (Gourmet). Blue Diamond Breaded Shrimp. Blue Diamond Gourmet Breaded Fantail Shrimp. Pacific Gold Gourmet Breaded Fantail Shrimp. Golden Bounty Gourmet Breaded Fantail Shrimp. Golden Bounty Golden Imitation Breaded Shrimp. Blue Diamond Coconut Breaded Shrimp (Round). Blue Diamond Coconut Breaded Shrimp (Butterfly). Blue Diamond Breaded Scallops (Natural). Blue Diamond Breaded Scallops (Special). Blue Diamond Breaded Oysters. Blue Diamond Breaded Pollock. Blue Diamond Breaded Cod. Blue Diamond Breaded Sole. Blue Diamond Breaded Calamari (Rings). Blue Diamond Breaded Calamari (Steaks). Blue Diamond Breaded Calamari (Strips). Blue Diamond Breaded Catfish. Blue Diamond Breaded Perch. Blue Diamond Baja Bullets Breaded Jalapeno Chiles Cheddar Cheese. Recall #F-249/275-0. CODE The container carries a Julian date with five digits. What is being recalled is Julian date "04500" or earlier. MANUFACTURER Golden Bounty Food Processors, Inc., Bell Gardens, California. RECALLED BY Manufacturer, by letter dated February 21, 2000. Firm-initiated recall ongoing. DISTRIBUTION Alaska, Arizona, California, Illinois, Montana, Nevada, Washington state. QUANTITY 10,024 cases were sold. REASON Products contain undeclared soy flour. ________ PRODUCT Greenís Homestyle Apricot Rugelah Sugar Free, in 8-ounce rigid plastic containers. Recall #F-282-0. CODE None. MANUFACTURER Green & Ackerman Bakery, Inc., Brooklyn, New York. RECALLED BY Manufacturer, by telephone July 28, 1999. Completed recall resulted from a sanitary inspection conducted by the New York State Department of Agriculture and Markets. DISTRIBUTION New York and New Jersey. QUANTITY Approximately 100 8-ounce packages were distributed. REASON Product contained undeclared FD&C Yellow No. 5, FD&C Red No. 40, potassium sorbate and sodium benzoate. ________ PRODUCT Diet Coke in 2 liter plastic bottles. Recall #F-284-0. CODE DEC2799KME. MANUFACTURER Coca-Cola Bottling Company of New York, Inc., Maspeth, New York. RECALLED BY Manufacturer, by E-mail on October 26, 1999, by press release issued on October 28, 1999, and by letter dated November 1, 1999. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 7,995 cases (8 bottles per case) were distributed. REASON Product is labeled as Diet Coke but actually contained Coca-Cola Classic, a regularly sweetened beverage. _______ PRODUCT Sunset Deli Tuna Sandwiches, Net Wt. 6 ounces. Recall #F-286-0. CODE Pull date 4 04 or earlier. MANUFACTURER Sunset Deli, Portland, Oregon. RECALLED BY Manufacturer, by visit between March 29 and 31, 2000, and by letter. Firm-initiated field correction (relabeling) complete. DISTRIBUTION Oregon. QUANTITY Firm estimates none remains on the market. REASON Product contained undeclared egg as a component ingredient of mayonnaise.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT Jagged Ice POWERaDE in 20-ounce bottles. Recall #F-283-0. CODE 0012CC. MANUFACTURER The Minute Maid Company for Coca-Cola USA at United Packers, Inc., Chattanooga, Tennessee. RECALLED BY Coca Cola USA Operations, Atlanta, Georgia, by letter issued on March 27, 2000. Firm-initiated recall ongoing. DISTRIBUTION Alabama, Florida, Georgia, Kentucky, Illinois, Indiana, Louisiana, Michigan, Mississippi, Montana, Nebraska, North Carolina, Ohio, Tennessee, Washington state, Wisconsin, Wyoming. QUANTITY Approximately 16,674 cases were distributed. REASON The product is contaminated with mold. ________ PRODUCT Bulkpac Golden Grams Breakfast Cereal in 2 pound 11.5 ounce plastic bags. Recall #F-285-0. CODE Best if Used By Dates of 14 DEC 00 U and 15 DEC 00 U. MANUFACTURER Rothbury Farms, Kentwood, Michigan (repacker/responsible firm). RECALLED BY General Mills, Inc., Minneapolis, Minnesota by letter dated March 17, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 7,099 cases (4 bags per case) were distributed. REASON Product is short weight.RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II
________ PRODUCT Body Lotion, in 18 fluid ounce/532 mL plastic bottles: a) Grass Body Lotion; b) Om Body Lotion; c) Earth Body Lotion. Recall #F-277/279-0. CODE Grass (style #388152-02-1); Codes: 9190QA, 9230QA Om (style #388152-00-1); Codes: 9237QA, 9237QB, 9202QA Earth (style #388152-01-1); Codes: 9207QA. MANUFACTURER Universal Packaging, Inc., Chino, California. RECALLED BY Gap, Inc., San Francisco, California, by letter dated March 9, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 23,300 bottles were distributed. REASON Products may be contaminated with Burkholderia cepacia.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT Red Blood Cells. Recall #B-523-0. CODE Unit #M02854. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone on January 18, 2000, and by letter dated January 19, 2000. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had traveled to an area designated as endemic for malaria. ________ PRODUCT Platelets, Pheresis. Recall #B-529-0. CODE Unit #53GP12903. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacture, by telephone on December 6, 1999, and by letter dated December 16, 1999. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 unit was distributed. REASON Platelets, Pheresis unit did not have a white blood cell count determination and was labeled as Leukocyte Reduced. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-530/531-0. CODE Unit #53GM21201. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated November 4, 1999, or fax on November 2, 1999. Firm-initiated recall complete. DISTRIBUTION District of Columbia and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had lived in the Congo. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-532/533-0. CODE Unit Numbers: 29GV32452 and 29GY08806. MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by letter dated October 14, 1999. Firm-initiated recall complete. DISTRIBUTION North Carolina and California. QUANTITY 2 units of each component were distributed. REASON Blood products were collected from a donor with a history of having tested positive for Hepatitis B. ________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-537/538-0. CODE Unit Numbers: a) 8078997; b) 8069032, 8078997, 8076546, 8083812, 8083806, 8076540. MANUFACTURER LifeShare, Inc., Elyria, Ohio. RECALLED BY Manufacturer, by telephone on November 24, 1999, and by letter dated November 30, 1999 and December 8, 1999. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY a) 1 unit; b) 6 units. REASON Six units of Platelets were implicated in a transfusion reaction, were found to be contaminated with staphylococcus, Coagulase negative. Corresponding blood products were distributed. ________ PRODUCT Red Blood Cells. Recall #B-545-0. CODE Unit #K72197. MANUFACTURER Blood Centers of the Pacific, San Francisco, California. RECALLED BY Manufacturer, by letter dated February 3, 1999. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had traveled to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-546-0. CODE Unit #GQ19256. MANUFACTURER Blood Centers of the Pacific, San Francisco, California. RECALLED BY Manufacturer, by telephone on April 26, 27, and 28, 1999. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was not quarantined after receiving information concerning a post donation illness. ________ PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c) Recovered Plasma. Recall #B-559/561-0. CODE Unit #S66889. MANUFACTURER Blood Centers of the Pacific, San Francisco, California. RECALLED BY Manufacturer, by letters dated May 18 and 22, 1998. Firm-initiated recall complete. DISTRIBUTION California and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood Products were collected from a donor with a history of hepatitis A. ________ PRODUCT Platelets, Pheresis. Recall #B-564-0. CODE Unit #LH16695. MANUFACTURER Blood Centers of the Pacific, San Francisco, California. RECALLED BY Manufacturer, by letter dated December 15, 1998. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-565/566-0. CODE Unit #1564020. MANUFACTURER Central Kentucky Blood Center, Lexington, Kentucky. RECALLED BY Manufacturer, by letter dated January 10, 2000. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-567-0. CODE Unit #1577225. MANUFACTURER Central Kentucky Blood Center, Lexington, Kentucky. RECALLED BY Manufacturer, by letter dated January 10, 2000. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-568-0. CODE Unit # 0390212. MANUFACTURER Hoxworth Blood Center, Cincinnati, Ohio. RECALLED BY Manufacturer, by letter dated March 24, 1999. Firm-initiated recall complete. DISTRIBUTION Ohio and Florida. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______ PRODUCT Red Blood Cells. Recall #B-525-0. CODE Unit #W06303. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone on January 3, 2000. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose arm inspection had not been documented. ________ PRODUCT Capture-R Ready-Screen (Pooled Cells) - 96 Wells containing Polled Screening Cells; Capture-R Ready-Screen (I and II) 48 Wells containing Screening Cell I and 48 Wells containing screening Cell II; and Capture-R Ready-ID for the identification of unexpected IgG Antibodies to Red Cells. Recall #B-548-0. CODE Kit Lot Numbers 43895, 43896, 43897, 43898, 43902, 43893, 43899. MANUFACTURER Immucor, Inc., Norcross, Georgia. RECALLED BY Manufacturer, by telephone on November 5, 1999, and by E-mail. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 1,624 kits were distributed. REASON When certain lots of the Capture-R Ready plates are read using an automated reading device, a high rate of equivocal or positive test reactions were obtained. ________ PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated. Recall #B-557-0. CODE Unit #21375-2819. MANUFACTURER Blood Systems, Inc., Fargo, North Dakota. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on November 19, 1999. Firm-initiated recall complete. DISTRIBUTION North Dakota. QUANTITY 1 unit was distributed. REASON Blood product was stored at unacceptable temperatures. ________ PRODUCT Red Blood Cells. Recall #B-558-0. CODE Unit Numbers: 0333054, 0333050, 0333043, 2270086. MANUFACTURER Inland Northwest Blood Center, Spokane, Washington. RECALLED BY Manufacturer, by telephone on December 17, 1999. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY 4 units were distributed. REASON Blood products remained at room temperature for an unacceptable length of time during irradiation. ________ PRODUCT Red Blood Cells. Recall #B-562-0. CODE Unit #12439-5644. MANUFACTURER United Blood Services, Albuquerque, New Mexico. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on July 29, 1999. Firm-initiated recall complete. DISTRIBUTION Colorado. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. _______ PRODUCT Platelets (expired), for further manufacture. Recall #B-569-0. CODE Unit #0390212. MANUFACTURER Hoxworth Blood Center, Cincinnati, Ohio. RECALLED BY Manufacturer, by letter dated March 24, 1999. Firm-initiated recall complete. DISTRIBUTION Ohio and Florida. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
________ PRODUCT Custom Procedure Based Delivery Systems Surgical Kits packaged to specifications form the customers, and containing recalled Techni-Care Surgical Prep. CODE Catalog No. PBOCDCTMP; Catalog No. PDOCLSTMP; Catalog No. PBOCPETMM; Catalog No. PBOCHYTMP; Catalog No. PBOCLSTMQ; Catalog No. PBOCPETMN; Catalog No. PBOCHYTMR; Catalog No. PBOCLVTMS; Catalog No. PL41VDPRG. Recall #Z-494/502-0. MANUFACTURER Allegiance Healthcare Corp., McGaw Park, Illinois RECALLED BY Manufacturer, by letter dated January 28, 2000, instructing the users to immediately discontinue use of the kits and return them to the firm. Firm-initiated recall completed. COMPONENT MANUFACTURER Care-Tech Laboratories, Inc., Division of Consolidated Chemical, Inc., St. Louis, Missouri. DISTRIBUTION Connecticut, Texas. QUANTITY 1,104 kits were distributed. REASON Techni-Care Surgical Prep solution in the kits is contaminated with Pseudomonas aeruginosa bacteria.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Allograft Heart Valve, Model Numbers - AV05, PV05, AV00, PV00. Recall #Z-480/483-0. CODE Serial Numbers: 3929116, 3929124, 6026427, 6026435. MANUFACTURER Cryolife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by letter on February 28 and 29, 2000. Firm-initiated recall complete. DISTRIBUTION Kansas, Michigan, Germany, Japan. QUANTITY 4 valves. REASON Donors did not meet current guidelines regarding serodilution of plasma. ________ PRODUCT IMMUNOCARD MYCOPLASMA, an ELISA diagnostic test kit for detection of IgM to Mycoplasma pneumoniae in human serum. Recall #Z-485-0. CODE Catalog #709030, Lot Numbers: 709030.091 through 709030.094; and 709030.097 through 709030.102. MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio. RECALLED BY Manufacturer, by letter dated March 13, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 3,694 units were distributed. REASON Test results and control results exhibit a high level of variability. ________ PRODUCT Allograft Heart Valve, Model Numbers PV00 and AV00. Recall #Z-486/487-0. CODE Serial numbers: 3877868, 3918009, 3918017. MANUFACTURER Cryolife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by letter sent on March 6 and 7, 2000. Firm-initiated recall complete. DISTRIBUTION Michigan and Canada. QUANTITY 3 valves. REASON Donors did not meet current guidelines regarding serodilution of plasma. ________ PRODUCT Venturi Ventilators Part #1572. Recall #Z-505-0. CODE Ventilators manufactured and distributed between June 24, 1997 and February 23, 2000. MANUFACTURER Cardiopulmonary Corporation, Milford, Connecticut. RECALLED BY Manufacturer, by fax/overnight mail between March 8-9, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Connecticut, Florida, New Jersey, North Carolina, South Carolina, Italy, United Kingdom, Saudi Arabia, France, Mexico. QUANTITY 109 units. REASON During extended use of the humidifier and the airway heater, the breathing bag may become soft and pliable. This condition when combined with high-pressure settings may allow the breathing bag to intermittently impede expiratory flow and lead to an interruption in exhalation and higher than expected airway pressures. ________ PRODUCT First Aid kits containing recalled Clinipad products: a) Blister Kit containing, in part, 5 sterile alcohol prep pads b) Pocket First Aid Kit containing, in part, 4 sterile alcohol prep pads c) Weekend Warrior First Aid Kit containing, in part, 3 sterile alcohol prep pads d) Cramer Personal First Aid Kit containing, in part, 6 sterile alcohol prep pads e) Retail First Aid Kit containing, in part, 15 sterile alcohol prep pads. Recall #Z-507-0. CODE a) Blister Kit - No lot number b) Pocket First Aid Kit - LKE169, LKK391 c) Weekend Warrior First Aid Kit - LKK400 d) Cramer Personal First Aid Kit - LKB061, LKC111, LKD112 LKG250, LKH308, LKK397 e) Retail First Aid Kit - LKC102, LKE160, LKF180, LKI313, LKK382. MANUFACTURER Cramer Products, Inc., Gardner, Kansas. RECALLED BY Manufacturer, by letter dated March 15, 2000, advising all consignees to remove and destroy the Clinipad Alcohol Prep Pads. Firm-initiated recall ongoing. Component Manufacturer Clinipad Corporation, Charlotte, North Carolina. DISTRIBUTION Nationwide. QUANTITY a) Blister Kits - 1,152; b) Pocket First Aid Kits - 1,217; c) Weekend Warrior First Aid Kits - 100; d) Cramer Personal First Aid Kits - 5,315; e) Retail First Aid Kits - 4,444. REASON First aid kits contain Clinipad Alcohol Prep Pads labeled as sterile for which Clinipad is unable to assure the sterility. ________ PRODUCT Boston Scientific Scimed Wiseguide MP HS 8 French Guide Catheters (Coronary Guiding Catheters), Catalog number 16320-41, designed to provide a pathway through which a medical instrument, such as a balloon catheter for treating coronary arteries, can be delivered. Recall #Z-510-0. CODE Lot #3005354. MANUFACTURER Scimed Life Systems, Inc., Boston Scientific Corporation, Maple Grove, Minnesota. RECALLED BY Manufacturer, by telephone on March 15, 2000. Firm-initiated recall complete. DISTRIBUTION Arizona, Colorado, South Carolina. QUANTITY 3 catheters were distributed. REASON The curved distal portion of the catheters could crack and break loose from the catheter shaft. ________ PRODUCT Heart Valve Allograft, Model AV00. Recall #Z-511-0. CODE Serial #3905802. MANUFACTURER Cryolife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by telephone on March 21, 2000. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 valve. REASON Donor did not meet current guidelines regarding serodilution of plasma. ________ PRODUCT Heart Valve Allograft, Model PV00. Recall #Z-512-0. CODE Serial #6684073. MANUFACTURER Cryolife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by letter dated March 21, 2000. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 valve. REASON Donor was unsuitable for allograft donation due to excessive plasma dilution at time serological samples were collected for testing. ________ PRODUCT Heart Valve Allograft, Model PV00 and AV00. Recall #Z-513/514-0. CODE Serial Numbers: 3905829, 6084338, 6084346, 6197469, 6197477, 6214975, 6214983 MANUFACTURER Cryolife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by letters dated March 17, 20, and 21, 2000. Firm-initiated recall complete. DISTRIBUTION Kentucky, Minnesota, Colorado, Florida, Tennessee. QUANTITY 7 valves. REASON Donor did not meet current guidelines regarding serodilution of plasma. ________ PRODUCT MINICAP XP Workstations, using Baseline 8.5 software, for Computed Tomography SPECT studies with gamma cameras. Recall #Z-515-0. CODE All Marconi MINICAP XP workstations using the Baseline 8.5 software. MANUFACTURER Marconi Medical Systems, Inc., Highland Heights, Ohio. RECALLED BY Manufacturer, by letter dated February 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 131 units were distributed. REASON During 360 degree SPECT, the resulting image will appear flipped left to right. ________ PRODUCT Heat Condenser Humidifier, Catalog No. 1571. Recall #Z-517-0. CODE Lot Numbers: 2-44910, 2-45910, 4-47910, 1-48910, 3-44910, 3-45910, 5-47910, 1-49910, 2-50910, 4-51910, 2-52910,3-49910, 3-50910, 3-52910, 4-49910, 6-49910. MANUFACTURER Hudson Respiratory Care, Inc., Temecula, California. RECALLED BY Manufacturer, by letter on January 10 and 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Canada, Japan, Thailand. QUANTITY 70,405 units were distributed. REASON The product contains a chemical odor that could compromise a patient during the device's initial use. ________ PRODUCT Sterile Procedure Kits/Trays containing recalled Clinipad products. Recall #Z-518-0. CODE i) Central Line Tray, catalog #470, lots 668, 669 ii) Dressing Change Tray, catalog #478, lots 668, 669 iii) Subclavian Dressing Change Tray, catalog #755, lot 669 iv) Hyperal Tray, catalog #580A, lots 667, 669 v) Cambridge Marketing I.V. Start Kit, catalog # SW4000, lot 667 vi) Subclavian Tray, catalog #359, lot 663 MANUFACTURER Sterling Medical-Products International, Inc., Prophetstown, Illinois. RECALLED BY Manufacturer, by letter on March 30, 2000, requesting all accounts and sub-accounts to destroy the Clinipad products. Firm-initiated recall ongoing. COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Illinois, South Carolina, Tennessee. QUANTITY 2,280 kits. REASON The kits and trays contain Clinipad products labeled as sterile for which Clinipad is unable to assure sterility. ________ PRODUCT Medline Sterile Procedure Kits/Trays containing recalled Clinipad Products. Recall Z-519-0. CODE Kit Catalog # Kit Description DMCHLDCT0 Central Line Dressing Change Tray DMGTPN01 TPN Tray DMHHCLDCT0 Central Line Dressing Change Tray DMHVPICC01 Fill Dressing Tray DYNDC1001 Central Line Dressing Change Tray DYNDC1002 Dressing Change Tray DYNDC1003 Central Line Dressing Tray DYNDC1005 Dressing Change Tray DYNDC1007 Dressing Change Tray DYNDC1009 Central Line Dressing Change Tray DYNDM1002 TPN Tray DYND74560 Central Line Dressing Change Tray DYND74561 Dressing Change Tray - Tegaderm DYND74562 Dressing Change Tray - Sureste DYND74565 Central Line Dressing Change Tray DYND74566 Dressing Change Tray - Tegaderm DYND30210 Midstream w/Funnel/PVP, 4oz Cup DYND30226 Midstream w/PVP, 4oz ECO DYNJ07141C Subclavian Tray DYNDM1004 Fistula Pack DYND12110 Cath Care Tray DYND20100 Sterile Irrigation Tray DYND20105 Sterile Bulb Irrigation Tray DYND20300 Sterile Irrigation Tray DYND20305 Irrigation Tray DYND70900 Suture Removal Tray DYND71030 Suture Removal Tray DYND74000 IV Start Kit DYND74003 IV Start Kit DYND74015 IV Start Kit DYND74053 IV Start Kit DYND74081 IV Start Kit DYND74100 Subclavian On Pack DYND74101 Subclavian Off Pack DYND74102 Fistula Pack DYND74226G On/Off Kit DYND74601 Blood Withdrawal Tray DYNJC2047D Port Starter Kit DYNJC2741 HYP Subclavian Dressing Tray DYNJC2777 Dressing Removal Tray DYNJ04000A IV Start Kit Flexigrid DYNJ04001 IV Start Kit DYNJ04014C IV Start Kit DYNJ04060 Skin Staple Removal Kit DYNJ04060 Skin Staple Removal Kit DYNJ04081 IV Start Kit DYNJ04156 IV Start Kit DYNJ04205A IV Start Kit DYNJ04208A IV Start Kit DYND04216 On/Off Tray DYNJ04242A Suture Removal Tray DYNJ04244 IV Start Kit DYNJ05611 IV Start Kit DYNJ05712B IV Start Kit DYNJ05877A IV Start Kit DYNJ07147 Incision & Drainage Tray DYNJ07179A Suture Removal Kit DYNJ07267B Subclavian Dressing Tray DYNJ07293 Wound Closure DYNJ07450 Dialysis Tray DYNJ15384 Suture Removal Tray MDS701550 Suture Removal Tray MDS706551 Suture Removal Tray MDS70815 Incision & Drainage Tray MDS708550 Suture Removal Tray Note 1: Home Care kits will be the same part numbers as listed above except there is an "H" suffix. Note 2: Single packs will be the same part numbers as listed above except there is a "Z" suffix. MANUFACTURER Medline Industries, Inc., Mundelein, Illinois. RECALLED BY Manufacturer, by letter dated March 16, 2000, requesting accounts not to use and destroy the Clinipad products when using the kits. The firmís sales representatives are to visit each account and attach to individual kits an orange sticker stating "RECALL DO Not Use The Clinipad Product Within This Kit Destroy The Clinipad Product". Firm-initiated recall ongoing. COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Nationwide. QUANTITY Approximately 230,000 kits. REASON Kits and trays contain Clinipad products labeled as sterile for which Clinipad is unable to assure sterility. ________ PRODUCT Sterile Catheter Irrigation Trays and Wound Dressing Trays; 20 trays per case containing recalled Clinipad Products: a) Visiting Health Professionals Catheter Irrigation Tray, Premium Custom Concepts, a Division of Premium Plastics, Inc., Chicago, IL 60616; reorder #3022016 b) Unicare Deluxe Facial Wound Closure Instrument Pack, reorder #2663 c) Unicare Wound Closure Tray, reorder #2665 Recall #Z-520-0. CODE a)Lots PE0038 and PG0063; b) Lot RF0020; c) Lots RF0025 and SH2156. MANUFACTURER Premium Plastics, Inc., Chicago, Illinois. RECALLED BY Manufacturer, by telephone on March 29, 2000, instructing the accounts to destroy the remaining entire kits for credit. Firm-initiated recall ongoing. COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION North Carolina and Puerto Rico. QUANTITY 5,820 trays. REASON Kits and trays contain Clinipad products labeled as sterile for which Clinipad is unable to assure sterility. ________ PRODUCT On/Off dialysis kits containing recalled Clinipad products as follows: a) MPC-595; b) MPC-590; c) MPC-685. Recall #Z-521-0. CODE a) MPC-595 - Lot #804917, 900975, 902649, 6L786, and 916129 b) MPC-590 - Lot #97G10B, 802258, 817819, 910665, VA0625, and AK982 c) MPC-685 - Lot #712084, 716073, 805046, 900984, and 914327 MANUFACTURER Molded Products, Harlan, Iowa. RECALLED BY Manufacturer, by telephone on March 20, 2000, followed by letter dated March 21, 2000, requesting accounts to destroy any recalled Clinipad product in the kits. Firm-initiated recall ongoing. COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Wisconsin and California. QUANTITY MPC-590 - 6,550 kits; MPC-595 - 3,650 kits; and MPC-685 - 41,450 kits. REASON Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility. ________ PRODUCT Medical PEG kits containing recalled Clinipad products: Surgitek Surgi-PEG, Initial Placement Gastrostomy Tray - Pullwire System 15FR, Cat #110115; Surgitek Surgi-PEG, Initial Placement Gastrostomy Tray - Pullwire System 20FR, Cat #1101120; Surgitek Surgi-PEG, Initial Placement Gastrostomy Tray - Pullwire System 24FR, Cat #1101124; Surgitek Surgi-PEG, Initial Placement Gastrostomy Tray - Guidewire System 15FR, Cat #1101215; Surgitek Surgi-PEG, Initial Placement Gastrostomy Tray - Guidewire System 20FR, Cat #1102120; Surgitek Surgi-PEG, Initial Placement Gastrostomy Tray - Guidewire System 24FR, Cat #1102124; Surgitek S.O.S., One-Step Button with Percutaneous Stoma Measuring Device - Guidewire Method 24FR 1.7cm, Cat #4018170; Surgitek S.O.S., One-Step Button with Percutaneous Stoma Measuring Device - Guidewire Method 24FR 2.4cm, Cat #4018240; Surgitek S.O.S., One-Step Button with Percutaneous Stoma Measuring Device - Guidewire Method 24FR 3.4cm, Cat #4018340; Surgitek S.O.S., One-Step Button with Percutaneous Stoma Measuring Device - Guidewire Method 24FR 4.4cm, Cat #4018440; Surgitek S.O.S., One-Step Button with Percutaneous Stoma Measuring Device - Guidewire Method 18FR 1.2cm, Cat #4118120; Surgitek S.O.S., One-Step Button with Percutaneous Stoma Measuring Device - Guidewire Method 18FR 1.7cm, Cat #4118170; Surgitek S.O.S., One-Step Button with Percutaneous Stoma Measuring Device - Guidewire Method 18FR 2.4cm, Cat #4118240; Surgitek S.O.S., One-Step Button with Percutaneous Stoma Measuring Device - Guidewire Method 18FR 3.4cm, Cat #4118340; Surgitek S.O.S., One-Step Button with Percutaneous Stoma Measuring Device - Guidewire Method 18FR 4.4cm, Cat #4118440; Percutaneous Stoma Measuring Device - Guidewire, Cat #PSMD-GW; Percutaneous Stoma Measuring Device - Pullwire, Cat #PSMD-PW. Recall #Z-526-0. CODE A total of 68 lot numbers are as follows: 97070353, 97070713, 97070714, 97070863, 97090709, 97070066, 97080305, 97080615, 97100463, 97100464, 97070581, 97080616, 97100471, 97040072, 97080304, 97100010, 97040511, 97040536, 97040787, 97050435, 97090008, 97100229, 97100472, 97110609, 97080303, 97110045, 97080589, 97090043, 97100486, 97070704, 97080069, 97080285, 97080597, 97090021, 97090882, 97100489, 97100631, 97050675, 97050901, 97070566, 97070702, 97080068, 97080289, 97080587, 97080592, 97080863, 97090041, 97090459, 97080288, 97080595, 97090039, 97090458, 97090702, 97100642, 97110603, 97080287, 97080596, 97090681, 97070570, 97080286, 97090683, 97090700, 97090457, 97090460, 97100112, 97100788, 97100804, and 97100787. MANUFACTURER Applied Medical Technology, Inc., Cleveland, Ohio. RECALLED BY Manufacturer, by letter on March 29, 2000, requesting that all accounts to remove and destroy the Clinipad products in the kits and to attached a warning sticker labeled, "WARNING: When this PEG kit is opened, please remove and destroy the enclosed Clinipad component", on any remaining kits in inventory. Firm-initiated recall ongoing. COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Wisconsin. QUANTITY 1,982 kits were distributed. REASON Kits contain Clinipad products labeled as sterile, for which Clinipad cannot assure the sterility. ________ PRODUCT Custom Procedure Ready Trays containing recalled Clinipad Products: 1) Part No. 16-01029, Custom Angio Card Cath Pack 2) Part No. 16-02130, Custom Adult Cardiac Cath Tray 3) Part No. 16-02355, Custom Cardiac Cath Lab Pack 4) Part No. 16-02451, Custom Angio Card Cath Pack 5) Part No. 18-02510, Custom Biopsy Tray Recall #Z-527-0. CODE 1) Lots MFG5994, MFG5955, MFG6086, MFG6098 2) Lots MFG5921, MFG6157 3) Lot MFG5978 4) Lot MFG6051 5) Lots MFG5848, MFG5917, MFG5927, MFG5937. MANUFACTURER Medical Techniques, In., North Salt Lake, Utah. RECALLED BY Manufacturer, by telephone and mail on March 17, 2000, instructing all accounts and sub-accounts to remove and destroy the Clinipad product inside the kits before using the kits. Replacement product was being sent for use in each kit. Firm-initiated recall ongoing. COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION New Jersey, Texas, Saudi Arabia. QUANTITY 450 trays were distributed. REASON The trays contained Clinipad products that lacked assurance of sterility. ________ PRODUCT First Aid Kits containing Clinipad Product: Model Numbers: 11000 12318 12600 12702 12703 12704 12988 12989 13300 13126 14302 14303 25001 26000 30500 33000 38000 40001 50000 51019 60002 60003. Recall #Z-528-0. CODE Lot Numbers: 299135, 299139, 299162, 299329, 299385, 299077, 299143, 299075, 298693, 299131, 299176, 299177, 299382, 299249, 299275, 299092, 299258, 299271, 299136, 299188, 299213, 299116, 299186, 299187, 299289, 299261, 299286, 298685, 299091, 299130, 299178, 299191, 299248, 299278, 299292, 299193, 299129, 299179, 299220, 299268, 299041, 299104, 299148, 299321, 299064, 299194, 299203, 299244, 299282, 298702, 299114, 299245, 299269, 299190, 299256, 299352, 298650, 298683, 298698, 298710, 299034, 299105, 299158, 299209, 299274, 298668, 299093, 299227, 299285, 299293, 299100, 299113, 299257, 299279, 299294, AND 299322. MANUFACTURER Acme United Corp., Fremont, North Carolina. RECALLED BY Acme United Corporation, Fairfield, Connecticut, by letter dated March 30, 2000, requesting all accounts and sub-accounts to call the firmís toll free hotline for instructions. Firm-initiated recall ongoing. COMPONENT MANUFACTURER Clinipad Corporation, Charlotte, North Carolina. DISTRIBUTION Nationwide. QUANTITY 2,228,697 products were repackaged into kits of 22 different configurations (models). REASON The kits contain Clinipad Alcohol Prep which have been recalled by the Clinipad Corporation for possible microbiological contamination.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT AXSYM Total B-HCG, for in vitro diagnostic use. Recall #Z-484-0. CODE List no.9C21-10, Lot # 57210Q100, EXP date 4/5/00 Lot # 59236Q100, EXP date 6/1/00. MANUFACTURER Abbott Health Products, Inc., Barceltoneta, Puerto Rico. RECALLED BY Manufacturer, by letter dated February 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 5,412 units were distributed. REASON Control values are greater than the package insert ranges. ________ PRODUCT CSI Daily Wear Clear Contact Lenses. Recall #Z-508-0. CODE Sub lot # 700022570404 Master lot #60300195. MANUFACTURER Wesley Jessen Corporation, Cidra, Puerto Rico. RECALLED BY Manufacturer, by letter dated March 13, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, Illinois, Maryland, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Virginia. QUANTITY 27 lenses were distributed. REASON Mislabeled for corrective power. The label indicates sphere power of +8.00. The lenses are actually -20.00. ________ PRODUCT Series II Compact Video Imager Multi Format Camera; used with gamma cameras, nuclear, C-Arm, and digital radiography. Recall #Z-509-0. CODE Model MP4600-2A-X, serial numbers 3162B, 3163B, 3164B. MANUFACTURER International Imaging Electronics, Bolingbrook, Illinois. RECALLED BY Manufacturer, by telephone followed by letter on March 9, 2000. Firm-initiated recall ongoing. DISTRIBUTION California. QUANTITY 3 units were distributed. REASON The video imagers had been shipped without final testing and final inspection. ________ PRODUCT Circon Surgitek Double J Silicone Ureteral Stents, Part Numbers 5202100 and 5202600, can be used to provide drainage from the kidneys to the bladder, and stenting of the ureter without external catheters. Recall #Z-516-0. CODE Product number 5202100, lots 631289H and 631299H Product number 5202600, lot 633359H. MANUFACTURER Circon Surgitek, Racine, Wisconsin. RECALLED BY Manufacturer, by letter dated March 10, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Austria, Canada, France, Ireland, The Netherlands. QUANTITY 360 stents. REASON Inner diameters of stents are too small to allow passage of guidewires.RECALLS AND FIELD CORRECTIONS:VETERINARY PRODUCTS -- CLASS I
________ PRODUCT a) DVM Nutri-Balance High Protein Dog Food, Product Code 52GP, 50-pound bags manufactured for Tri-State Veterinary Supply, Sioux City, IA; b) Golden Sun Feeds Hi-Pro Hunter Dog Food, product code 52GY, 50-pound bags manufactured for Golden Sun Feeds, Inc., Estherville, IA. Recall #V-067/068-0. CODE Lot 264 E9. MANUFACTURER Golden Sun Feeds, Inc., Estherville, Iowa. RECALLED BY Manufacturer, by telephone on December 17, 1999, and by press release and overnight mailers on December 21, 1999. Firm-initiated recall ongoing. DISTRIBUTION South Dakota, Nebraska, Indiana, Iowa, Minnesota, Wyoming, Kansas, Wisconsin, Missouri. QUANTITY a) 120/50-lb bags; b) 472/50-lb bags were distributed. REASON Products may be contaminated with high levels of Vitamin D-3 supplement. END OF ENFORCEMENT REPORT FOR APRIL 19, 2000.####
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