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Voluntary Recall of Heparin Sodium USP Pre-Filled Syringes Issued

MANSFIELD, Massachusetts – March 28, 2008 - Covidien, formerly Tyco Healthcare, was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL), of a nation-wide 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.
Product Lot numbers
REF # 8881580121
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe, 10mL
7082274, 7113214
REF # 8881580123
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe, 3mL
7051524, 7113214
REF # 8881580125
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe 5mL
7051524, 7082274, 7113164, 7113174
REF # 8881580300
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe
2.5mL in 3mL syringe
7051444
REF # 8881581125
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe 5mL, with BLUNTIP plastic cannula
7082274
REF # 8881590121
Monoject PreFillTM 100U/mL Heparin
Lock Flush Syringe 10mL
7113064
REF # 8881590123
Monoject PreFillTM 100U/mL Heparin
Lock Flush Syringe 3mL
7041194, 7072154, 7113034, 8010194
REF # 8881590125
Monoject PreFillTM 100U/mL Heparin
Lock Flush Syringe 5mL
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
7082284

Covidien began recalling the lots today as a precautionary measure. This product recall was initiated due to a notification received from the supplier, SPL, disclosing that two 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 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, diarrhea 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 – 5:00pm (ET), Monday through Friday.

Source: Food and Drug Administration

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