May 13, 1998 98-19 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Manhattan Frozen Pineapple Fruit Bars, 2.5 fluid ounces. Recall #F-478-8. CODE All lots. MANUFACTURER Manhattan Frozen Products, Inc., San Antonio, Texas. RECALLED BY Manufacturer, by letter March 31, 1998. Firm-initiated recall ongoing. DISTRIBUTION Louisiana, Oklahoma, Texas. QUANTITY 33 cases (1,584 bars) were distributed. REASON Product contains undeclared FD&C Yellow No. 5. _______________ PRODUCT Ready-to-eat and microwaveable sandwiches: a) Tuna Salad Sandwich b) Chicken Salad Sandwich c) Egg Salad Sandwich d) Real Cuban Sandwich e) Junior Real Cuban Sandwich f) Submarine Sandwich h) Cheeseburger Deluxe (microwaveable) I) Super Deluxe Cheeseburger (microwaveable) Recall #F-480/487-8. CODE All sell by dates prior, but not including, 4/16. MANUFACTURER A to Z Sandwich Company, Jacksonville, Florida. RECALLED BY Manufacturer, by telephone on April 1, 1998. Firm-initiated recall complete. DISTRIBUTION Georgia, Florida. QUANTITY Approximately 2,000-5,000 sandwiches remained on market at time of recall initiation. REASON Products contained undeclared FD&C Yellow No. 5. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I ============ _______________ PRODUCT Kendall Healthcare Products brand Modudose, 0.9% Sodium Chloride (saline Solution), single use vial for respiratory therapy, in 1.5, 3, and 5 mL vials. Reorder 5251 - NDC 50738-010-18; Reorder 5257 - NDC 50738-010-19; Reorder PR5251 - NDC 50738-010-18. Recall #D-120-8. CODE All lot numbers. MANUFACTURER Kendall Healthcare Products Company, Ocala, Florida. RECALLED BY Kendall Healthcare Products, Mansfield, Massachusetts, by press release on April 9, 1998, followed by letter April 10-13, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY Product code numbers #5251 and #5257 - 41,946 cases and 6,851 cases respectively (1000 vials per case); Product code #PR5251 - 216 cases; Product code #0454 - 200 cases distributed. REASON Microbial contamination-Ralstonia Pickettii (formerly Bulkholderia Pickettii formerly Pseudomonas Pickettii). RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II =========== _______________ PRODUCT Various OTC products, distributed under generic and various brand names including Health Care, Pharmacy Classics, Personal Care, and Equality Health Care: a) Liquid Antacid (Magnesium Hydroxide 200 mg/Aluminum Hydroxide 200 mg) in 12 fluid ounce bottles b) Liquid Antacid with Simethicone (Magnesium Hydroxide 200 mg/Aluminum Hydroxide 200 mg/Simethicone 20 mg), in 12 fluid ounce bottles c) Children's Acetaminophen Elixir (Acetaminophen 160 mg) cherry flavored in 4 fluid ounce bottles d) Sore Throat Spray (Phenol 1.4%) alcohol/sugar free, in 6 fluid ounce bottles e) Children's Night Time (Dextromethorphan Hydrobromide 15 mg/Chlorpheniramine Maleate 2 mg/Pseudoephedrine Hydrochloride 30 mg), in 6 fluid ounce bottles f) Nightime(Nite Time) for Adults (Acetaminophen 1000 mg/Dextromethorphan Hydrobromide 30 mg/Doxylamine Succinate; g) Pink Bismuth (Bismuth subsalicylate 262 mg/tablespoon) in 6 fluid ounce bottles h) Pediatric Tussin (Dextromethorphan Hydrobromide 7.5 mg) in 4 fluid ounce bottles I) Tussin Syrup/Tussin DM (Guaifenesin USP 100 mg/Dextromethorphan Hydrobromide USP 10 mg) in 4 fluid ounce bottles j) Milk of Magnesia (Magnesium Hydroxide 400 mg) in 12 fluid ounce bottles. Recall #D-121/130-8. CODE All lots on the market within expiration date. MANUFACTURER South Atlantic Industries, Inc., Greenville, South Carolina. RECALLED BY Manufacturer, by letter on or about April 1, 1998. Firm-initiated recall ongoing. DISTRIBUTION Michigan, Mississippi, North Carolina, Georgia, California, Ohio, Illinois, New York. QUANTITY Undetermined. REASON Lack of good manufacturing practice controls. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT Hemocare Blood Bank Data Management System Computer Software, Revision 5.1 & Version 3.1. Recall #B-556-8. CODE Revision 5.1 and Version 3.1. MANUFACTURER Mediware Information Systems, Inc. (MISI), Melville, New York. RECALLED BY Manufacturer, by letter on September 30, 1997, and by newsletter on December 15, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Canada, Singapore. QUANTITY Out of 226 sites, 225 have 5.1 version released May 1995 and 1 have 3.1 version released July 1992. REASON Computer software that: 1) Was not functioning as intended in that discrepant displays of ABO test results could be accepted after a system warning and supervisory override, which could potentially result in the release of mistyped or mislabeled blood products; and 2) Possesses limitations for use that are not adequately described in labeling. _______________ PRODUCT Platelets, Pheresis. Recall #B-732-8. CODE Unit numbers: 12GW11973A, 12GW11973B. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by telephone and letter on January 22, 1998. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 2 units were distributed. REASON Blood products had high platelet counts. _______________ PRODUCT Red Blood Cells. Recall #B-825-8. CODE Unit #40FK34209. MANUFACTURER American Red Cross, Heart of America Region, Peoria, Illinois. RECALLED BY Manufacturer, by letter dated February 24, 1998. Firm-initiated recall complete. DISTRIBUTION Missouri and Maryland. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to a malarial endemic area. _______________ PRODUCT Red Blood Cells. Recall #B-835-8. CODE Unit #49J74052. MANUFACTURER American Red Cross Blood Services, Norman, Oklahoma. RECALLED BY American Red Cross Blood Services, Tulsa, Oklahoma, by letter dated March 9, 1998. Firm-initiated recall complete. DISTRIBUTION Oklahoma. 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 Red Blood Cells; b) Platelets. Recall #B-838/839-8. CODE Unit #42FG48476. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by letter dated June 23, 1997. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. _______________ PRODUCT Red Blood Cells. Recall #B-840-8. CODE Unit #42T53275. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by telephone on March 6, 1997. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with an unacceptable hemoglobin. _______________ PRODUCT Baxter Fenwal Blood-Pack Container Systems. Recall #B-917-8. CODE Lot # M97J****, M97K****, M97L**** Where "****" are variety of numerals. MANUFACTURER Baxter Healthcare Corporation, Fenwal Division, Deerfield, Illinois. RECALLED BY Manufacturer, by letter dated February 17, 1998. Firm-initiated recall complete. DISTRIBUTION Nationwide and Canada. QUANTITY Approximately 3,000,000 units were distributed. REASON Leaking cannulas in Baxter's blood pack Containers may cause the volume of anticoagulant to be reduced due to the flow from the original blood container to the attached tubing and empty satellite packs. _______________ PRODUCT a) Red Blood Cells; b) Platelets c) Cryoprecipitated AHF d) Fresh Frozen Plasma e) Recovered Plasma. Recall #B-965/969-8. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by letters dated September 1, 1997, October 1 and 24, 1997, or February 26, 1998. Firm-initiated recall complete. DISTRIBUTION Illinois, Iowa, North Carolina, South Carolina, Idaho, Mississippi. QUANTITY a) 32 units; b) 2 units; c) 1 unit; d) 11 units; e) 14 units were distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1. _______________ PRODUCT a) Red Blood Cells b) Red Blood Cells, Leukocytes Removed c) Platelets; d) Platelets, Pheresis e) Fresh Frozen Plasma f) Fresh Frozen Plasma, Pheresis g) Source Leukocytes, for further manufacture h) Recovered Plasma, Frozen I) Recovered Plasma, Liquid j) Platelets, for further mfg. Recall #B-977/986-8. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana. RECALLED BY Manufacturer, by telephone and by letters dated June 30, 1997. Firm-initiated recall complete. DISTRIBUTION Indiana, Massachusetts, Utah, New Jersey, Switzerland. QUANTITY a) 31 units; b) 1 unit; c) 9 units; d) 11 units; e) 4 units; f) 1 unit; g) 3 unit; h) 19 units; I) 2 units; j) 5 units were distributed. REASON Blood products tested negative for HBsAg, HIVAG, HTLV, or HBc but collected from donors who initially tested reactive for HBsAg, HIVAG, HTLV, or HBc, with units not retested in duplicate, and donors were incorrectly reentered. _______________ PRODUCT Red Blood Cells. Recall #B-988-8. CODE Unit #21GV00550. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter dated February 25, 1998. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of cancer. _______________ PRODUCT Platelets, Pheresis. Recall #B-989-8. CODE Unit #21P74690. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter dated February 11, 1998. Firm-initiated recall complete. DISTRIBUTION Oregon. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose spouse tested positive for hepatitis C. _______________ PRODUCT Red Blood Cells. Recall #B-990-8. CODE Unit #11C93144. MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri. RECALLED BY Manufacturer, by telephone on December 31, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was not quarantined after the donor requested that the unit be destroyed. _______________ PRODUCT Red Blood Cells. Recall #B-1015-8. CODE Unit #3881294. MANUFACTURER Camp Memorial Blood Center, Fort Knox, Kentucky. RECALLED BY Manufacturer, by fax dated September 25, 1997 and November 14, 1997. Firm-initiated recall complete. DISTRIBUTION Virginia, District of Columbia, New Mexico, California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose suitability was not adequately determined. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1019/1020-8. CODE Unit numbers: 29GP42535, 29GP47484, 29GS02456. MANUFACTURER The American Red Cross, Norfolk, Virginia. RECALLED BY Manufacturer, by letter dated January 20, 1998. Firm-initiated recall complete. DISTRIBUTION California, North Carolina, Virginia, Switzerland. QUANTITY 3 units of each component were distributed. REASON Blood products were collected from a donor taking Megestrol. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1025/1026-8. CODE Unit #3877744. MANUFACTURER Camp Memorial Blood Center, Fort Knox, Kentucky. RECALLED BY Manufacturer, by fax dated either August 7 or 8, 1997. Firm-initiated recall complete. DISTRIBUTION Kentucky, Missouri, Pennsylvania. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor whose suitability was not adequately determined. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1035/1036-8. CODE Unit #3876773. MANUFACTURER Camp Memorial Blood Center, Fort Knox, Kentucky. RECALLED BY Manufacturer, by dated August 7, 1997. Firm-initiated recall complete. DISTRIBUTION California, Pennsylvania, New Jersey. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had taken medication within four weeks of donation. _______________ PRODUCT Recovered Plasma. Recall #B-1052-8. CODE Unit #16LN10163. MANUFACTURER American Red Cross Blood Services, Columbus, Ohio. RECALLED BY Manufacturer, by fax on November 24, 1997. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of Multiple Sclerosis. _______________ PRODUCT Red Blood Cells. Recall #B-1053-8. CODE Unit #3872547. MANUFACTURER Camp Memorial Blood Center, Fort Knox, Kentucky. RECALLED BY Manufacturer, by fax on September 12, 1997. Firm-initiated recall complete. DISTRIBUTION New Jersey. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who may have traveled to an area considered endemic for malaria. _______________ PRODUCT Platelets, Pheresis. Recall #B-1054-8. CODE Unit #P05801. MANUFACTURER South Bend Medical Foundation, Inc., South Bend, Indiana. RECALLED BY Manufacturer, by telephone on March 6, 1998. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood product was positive for anti-E antibodies was labeled negative for unexpected antibodies. _______________ PRODUCT a) Whole Blood; b) Red Blood Cells c) Platelets; d) Platelets, Pheresis e) Fresh Frozen Plasma; f) Plasma g) Cryoprecipitated AHF h) Recovered Plasma I) Platelets, for further manufacture. Recall #B-1055/1063-8. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by telephone on September 27, 1996 and/or letters between October 3, 1996, and September 23, 1997, and June 9, 1997 or October 10, 1997. Firm-initiated recall complete. DISTRIBUTION Ohio, Wisconsin, Tennessee, California, New York, Massachusetts, Florida, Switzerland. QUANTITY a) 3 units; b) 76 units; c) 32 units; d) 49 units; e) 2 units; f) 9 units; g) 3 units; h) 67 units; I) 1 unit was distributed. REASON Blood products 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 and were incorrectly reentered. _______________ UPDATE Red Blood Cells; Blood Cells, Leukocytes Removed; Platelets, Fresh Frozen Plasma; Source Leukocytes; Recovered Plasma, Recall #B-835/840-8, Central Indiana Regional Blood Center, Inc., which appeared in the April 22, 1998 Enforcement Report has been recinded. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== ______________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall #B-836-8. CODE Unit #11318-4356. MANUFACTURER United Blood Services, El Paso, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on March 5, 1998. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was stored at an unacceptable temperature. _______________ PRODUCT Red Blood Cells. Recall #B-871-8. CODE Unit numbers: GW25773 and GW26041. MANUFACTURER Metropolitan Washington Blood Bank, Bethesda, Maryland. RECALLED BY Manufacturer, by telephone on or about January 22, 1997. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 2 units were distributed. REASON Blood products were labeled with an extended expiration date. _______________ PRODUCT Red Blood Cells. Recall #B-899-8. CODE Unit #06GQ52620. MANUFACTURER American Red Cross, Los Angeles, California. RECALLED BY Manufacturer, by telephone on January 13, 1997. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was not quarantined after receiving information concerning a post donation viral infection. _______________ PRODUCT Red Blood Cells. Recall #B-921-8. CODE Unit numbers: 1412170 and 0261687. MANUFACTURER Central Jersey Blood Center, Shrewsbury, New Jersey. RECALLED BY Manufacturer, by telephone on January 3, 1996. Firm-initiated recall complete. DISTRIBUTION New Jersey. QUANTITY 2 units were distributed. REASON Blood products were labeled with an extended expiration date. _______________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-999/1000-8. CODE Unit #11318-0525. MANUFACTURER United Blood Services, El Paso, Texas. RECALLED BY Blood Services, Inc., Scottsdale, Arizona, by telephone on January 28, 1998. Firm-initiated recall complete. DISTRIBUTION Texas and New Mexico. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who's suitability was not properly performed according to the firm's procedures for medication deferral. _______________ PRODUCT Red Blood Cells. Recall #B-1033-8. CODE Unit #3881292. MANUFACTURER Camp Memorial Blood Center, Fort Knox, Kentucky. RECALLED BY Manufacturer, by fax dated September 25, 1997. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported having flu like symptoms. _____________ PRODUCT Red Blood Cells. Recall #B-1034-8. CODE Unit numbers: 13GQ06124, 13GZ27235, 13GZ27248. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by letter dated February 4, 1998. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 3 units were distributed. REASON Blood products were leukoreduced greater than seven days after collection. _______________ PRODUCT Reduced Volume Platelets. Recall #B-1037-8. CODE Unit #12R75503. MANUFACTURER American Red Cross, Appalachian Regional Blood Services, Roanoke, Virginia. RECALLED BY Manufacturer, by telephone on February 27, 1998, and by letter dated March 9, 1998. Firm-initiated recall complete. DISTRIBUTION West Virginia. QUANTITY 1 unit was distributed. REASON Unlicensed blood product was distributed in interstate commerce. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1038/1039-8. CODE Unit #2259840. MANUFACTURER Camp Memorial Blood Center, Fort Knox, Kentucky. RECALLED BY Manufacturer, by fax dated September 12, 1997, or November 10, 1997. Firm-initiated recall complete. DISTRIBUTION Virginia, Georgia, District of Columbia. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who exceeded the donation acceptance criteria for body temperature. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1050/1051-8. CODE Unit #36245-2887. MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated October 6, 1997. 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 ulcerative colitis. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I ========== _______________ PRODUCT Tesio Extender Adaptor used with the Tesio Catheter. The catheter extender is connected after the catheter is inserted to allow for easier access during dialysis treatments, and is part of a hemodialysis access kit: a) Part #MBR-6 Trays; b) Part #MBL-6 Trays. Recall #Z-544/545-8. CODE MBL-6'S EXP MBR-6'S EXP M726310 11/02 M722710 09/02 M726320 11/02 M723740 10/02 M726920 11/02 M724260 10/02 M726930 11/02 M724350 10/02 M727450 11/02 M724640 10/02 M729700 12/02 M724680 10/02 M800910 01/03 M724960 10/02 M801550 01/03 M724980 10/02 M801850 2003/01 M725160 10/02 M801940 2003/01 M725170 10/02 M726330 11/02 M726340 12/02 M726350 12/02 M727900 11/02 M727980 12/02 M729000 12/02 M729430 12/02 M729540 12/02 M729710 12/02 M729720 12/02 M730050 01/03 M730730 01/03 M800180 01/03 M800190 01/03 M800900 01/03 M801870 2003/01. MANUFACTURER Martech Medical Products, Inc., Harleysville, Pennsylvania (component). RECALLED BY Medical Components, Inc. (MEDCOMP), Harleysville, Pennsylvania, by fax letter on March 24, 1998. Firm-initiated recall ongoing. See also FDA press release 98-11, dated March 27, 1998. DISTRIBUTION California, Florida, Michigan, Minnesota, Missouri, New Jersey, Tennessee, Texas, Utah, Virginia, Washington, and international. QUANTITY Approximately 7,000 kits were distributed. REASON The extender may separate from the adaptor. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT 20" Color Display, Part #960-208-010 used in Horizon 9000WS Cath Lab: a) Model No. GDM-20E01T b) Model No. GDM-20SE10; c) Model No. GDM-2039. Recall #Z-550/552-8. CODE None. MANUFACTURER Mennen Medical Corporation, Clarence, New York, RECALLED BY Manufacturer, by voice mail followed by memorandum dated May 24, 1995. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 82 units were distributed. REASON The base of display cracked and fell from its mount. _______________ PRODUCT Mitsubishi Product No. EXL-150 OP Linear Accelerator Patient Couch, uses electronically produced radiation to treat various types of cancers. Recall #Z-557-8. CODE Serial #4511. MANUFACTURER Mitsubishi Electric Corporation, Amagaski City, Hyogo, Japan. RECALLED BY Mitsubishi Electronics America, Somerset, New Jersey, by telephone on October 23, 1997. Firm-initiated recall ongoing. DISTRIBUTION New York. QUANTITY 1 unit was distributed. REASON The motor stop functions cannot be controlled via the couch button release, and the "stop" circuit is disabled when the drive unit cover microswitch is actuated, possibly causing patient injury. ______________ PRODUCT Child and Infant Bageasy Disposable Manual Resuscitators: a) Child Bageasy Manual Resuscitator Part/Catalog Part Number Description 562042 Child BagEasy with Peep and Mask, Sample (Single) 562043 Child BagEasy with Peep, Sample (Single) 562044 Child BagEasy with Mask, Sample (Single) 562045 Child BagEasy, Sample (Single) 562052 Large Child BagEasy w/Peep and Mask Sample (Single) 562053 Large Child BagEasy with Peep, Mask and 10 ft. 562068 Large Child BagEasy with Mask & 10 ft. Tubing, Box of 12 562069 Child BagEasy with Peep, Mask & 10 ft.Tubing, Box of 12 562070 Child BagEasy with Peep and 10 ft. Tubing, Box of 12 562071 Child BagEasy with Mask & 10 ft, tubing, Box of 12 562072 Child BagEasy with 10 ft. Tubing, Box of 12 562080 Child BagEasy with Peep & Mask, Box of 12 562081 Child BagEasy with Peep without Mask, Box of 12 562082 Child BagEasy without Peep with Mask, Box of 12 562083 Child BagEasy without Peep without Mask, Box of 12 562132 Child/Large Child BagEasy with Mask, Box of 12 562133 Child/Large Child BagEasy with Peep and Mask, Box of 12 b) Infant Bageasy Manual Resuscitators Part/Catalog Part Number Description 562046 Infant BagEasy with Peep and Mask, Sample (Single) 562047 Infant BagEasy with Peep, Sample (Single) 562048 Infant BagEasy with Mask, Sample (Single) 562049 Infant BagEasy Sample (Single) 562050 Neonatal/Infant BagEasy with Mask Sample (Single) 562051 Neonatal/Infant BagEasy with Peep & Mask Sample (Single) 562073 Infant BagEasy with Peep, Mask and 10 ft. Tubing, Box of 12 562074 Infant BagEasy with Peep and 10 ft.Tubing, Box of 12 562075 Infant BagEasy with Mask and 10 ft. Tubing, Box of 12 562076 Infant BagEasy with 10 ft. Tubing, Box of 12 562077 Neonatal/Infant BagEasy with Mask and 10 ft. 562079 Neonatal/Infant BagEasy with Peep, Mask and 10 ft 562084 Infant BagEasy with Peep and Mask, Box of 12 562085 Infant BagEasy with Peep without Mask, Box of 12 562086 Infant BagEasy without Peep with Mask, Box of 12 562087 Infant BagEasy without Peep without Mask, Box of 12 562110 Neonatal/Infant BagEasy with Mask, Box of 12 562111 Neonatal/Infant BagEasy with Peep and Mask, Box of 12. Recall #Z-559/560-8. CODE Lot Nos. A960521 through A971201. MANUFACTURER Respironics, Murrysville, Pennsylvania. RECALLED BY Manufacturer, by telephone on December 5, 1997, followed by letter on December 8, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and United Arab Emirate. QUANTITY 43,000 units were distributed. REASON The duckbill valve sticks and will not allow the caregiver to ventilate the patient. _______________ PRODUCT Adult Bageasy Disposable Manual Resuscitators, all types and models. Recall #Z-561-8 CODE A960521 through A971201 and B960521 through B971201. MANUFACTURER Respironics, Inc., Murrysville, Pennsylvania. RECALLED BY Manufacturer, by letter on December 8, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 430,000 units were distributed. REASON The duckbill valve sticks and will not allow the caregiver to ventilate the patient. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT Todd Hewitt with CNA (Lim Broth), recommended for use in qualitative procedures to isolate group B streptococci from clinical specimens containing mixed bacterial flora: a) Product #06-4810; b) Product #06-4812. Recall #Z-489/490-8. CODE Lot #5516 EXP 8/31/97. MANUFACTURER Remel Limited Partnership, Lenexa, Kansas. RECALLED BY Manufacturer, by telephone on October 21 and 22, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 9,240 plates were distributed. REASON Some patient isolates were exhibiting variable growth patterns of Group B Streptococcus in the medium. _______________ PRODUCT TAS Prothrombin (PT) Time Cards, intended for use with the TAS Analyzer and TAS aPTT test card to provide a quality control method for the system. Recall #Z-553-8. CODE Catalog No. 1001, Lot Nos. 93001701, 93001702, 93001703, 30201701, 30201702, 30201703, 302049702. MANUFACTURER Cardiovascular Diagnostics, Inc., Raleigh, North Carolina. RECALLED BY Manufacturer, by letter on June 4, 1997. Firm-initiated recall complete. DISTRIBUTION Arizona, California, Iowa, Illinois, Louisiana, Michigan, Minnesota, Pennsylvania, South Carolina, Virginia. QUANTITY 538 units were distributed. REASON The prothrombin results were high on patients on warfarin and the cards are subject to premature stability degradation. _______________ PRODUCT TAS APTT Abnormal Control Test Cards, used with the TAS Analyzer and is intended for the determination of the Prothrombin time of citrated whole blood or plasma. Recall #Z-554-8. CODE Catalog #1024, Lot #137039701. MANUFACTURER Cardiovascular Diagnostics, Inc., Raleigh, North Carolina. RECALLED BY Manufacturer, by letters on June 5 and 19, 1997. Firm-initiated recall complete. DISTRIBUTION Florida, Louisiana, Michigan. QUANTITY 49 units were distributed. REASON There was premature stability degradation. _______________ PRODUCT QED Salvia Alcohol Tests, in-vitro diagnostic used as a test to determine the alcohol content in a person's salvia: a) QED Saliva Alcohol Test A150; b) QED Saliva Alcohol Test A350. Recall #Z-555/556-8. CODE All lot numbers with an expiration date of July 1998 and later. MANUFACTURER STC Technologies, Inc., Bethlehem, Pennsylvania. RECALLED BY Manufacturer, by telephone on February 3, 1998, and by fax on February 16, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY Firm estimated that less than 10 percent of product remained on market at time of recall initiation. REASON The QA stop does not develop within 5 minutes using negative samples, as specified in the product labeling. _______________ PRODUCT Triflex Sterile Latex Surgical Gloves. Recall #Z-558-8. CODE Catalog 2D7252, Lot PGJ7N009, size 6-1/2 MANUFACTURER Allegiance Healthcare Corporation, West Malaysia. RECALLED BY Allegiance Healthcare Corporation, McGaw Park, Illinois, by letter dated April 16, 1998. Firm-initiated ongoing. DISTRIBUTION Nationwide. QUANTITY 262,800 pairs of gloves were distributed; firm estimated that 33 percent of product remained on market at time of recall initiation. REASON Mislabeling - The sterile pouch, labeled as size 6-1/2 gloves, may actually contain size 7-1/2 gloves which are marked properly as size 7-1/2 on the glove and inner wallet. The sterile pouches, boxes and cases are all labeled as size 6-1/2. _______________ PRODUCT Ventricular Catheter, Small, Barium Impregnated, 23 cm. Recall #Z-562-8. CODE Catalog #41207, Lot #L0391 EXP 10/02. MANUFACTURER Medtronics PS Medical, Goleta, California. RECALLED BY Manufacturer, by telephone on March 13, 1998. Firm-initiated recall ongoing. DISTRIBUTION California, Virginia, Texas, North Carolina, Pennsylvania, Ohio, Wisconsin, Washington state, Indiana, Louisiana, Connecticut, Austria, Belgium. QUANTITY 100 units were distributed. REASON The label on the outer carton may not be consistent with the correct label on the inner product package. The outer carton label may state that the catalog number is 41101 and that its catheter size is standard. However, the outer carton should have been labeled with catalog number 41207 and with a catheter size of small. END OF ENFORCEMENT REPORT FOR MAY 13, 1998. BLANK PAGES MAY FOLLOW.End of Enforcement Report for