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Covidien Initiates Voluntary Recall of Pre-Filled Syringes Containing Heparin MANSFIELD, Mass -- April 3 2008 -- Covidien, formerly Tyco Healthcare, was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL), of a nationwide recall of heparin sodium USP active pharmaceutical ingredient. The voluntary recall affects the following 32 lots manufactured and distributed by Covidien in the United States. REF # 8881580121 Monoject PreFillTM 10U/mL Heparin Lock Flush Syringe, 10mL Lot Numbers: 7082274, 7113214 REF # 8881580123 Monoject PreFillTM 10U/mL Heparin Lock Flush Syringe, 3mL Lot Numbers: 7051524, 7113214 REF # 8881580125 Monoject PreFillTM 10U/mL Heparin Lock Flush Syringe 5mL Lot Numbers: 7051524, 7082274, 7113164, 7113174 REF # 8881580300 Monoject PreFillTM 10U/mL Heparin Lock Flush Syringe 2.5mL in 3mL syringe Lot Number: 7051444 REF # 8881581125 Monoject PreFillTM 10U/mL Heparin Lock Flush Syringe 5mL, with BLUNTIP plastic cannula Lot Number: 7082274 REF # 8881590121 Monoject PreFillTM 100U/mL Heparin Lock Flush Syringe 10mL Lot Number: 7113064 REF # 8881590123 Monoject PreFillTM 100U/mL Heparin Lock Flush Syringe 3mL Lot Numbers: 7041194, 7072154, 7113034, 8010194 REF # 8881590125 Monoject PreFillTM 100U/mL Heparin Lock Flush Syringe 5mL Lot Numbers: 7041194, 7102804, 7041204, 7113034, 7051534, 7113044, 7051544, 7113054, 7051554, 7113104, 7071924, 7113114, 7072034, 7113154, 7072044, 8010064, 7072054, 8010114, 7072064, 8010134, 7072154, 8010174, 7082284 REF # 8881591125 Monoject PreFillTM 100U/mL Heparin Lock Flush Syringe 5mL, with BLUNTIP plastic cannula Lot Number: 7082284 Covidien began recalling the lots this week as a precautionary measure. This product recall was initiated due to a notification received from the supplier, SPL, disclosing that 2 lots of Heparin Sodium USP Active Pharmaceutical Ingredient acquired by Covidien had a heparin-like contaminant. To date, Covidien has not received any adverse event reports related to this issue. Although a very small product line for Covidien, the company is committed to following the direction of the US Food and Drug Administration (FDA) regarding this matter. The FDA has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant. As indicated in the notification issued by the supplier SPL, typical symptoms include anaphylactic-like reactions such as low blood pressure, shortness of breath, nausea, vomiting, diarrhoea and abdominal pain. Adverse reactions or quality problems experienced in the U.S. with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. -- Online: www.fda.gov/medwatch/report.htm -- Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to: MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787 -- Fax: 1-800-FDA-0178 Customers who have product in their possession from the recalled product lots should discontinue use immediately. Patients reporting any problems that may be related to the use of this product should be advised to contact a physician. Customers with questions about the return of recalled product should contact the Return Coordinator at 1-800-346-7197, ext. 8677, between 8:30am and 5:00pm (ET), Monday through Friday. SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version