MANSFIELD, Mass.--(BUSINESS WIRE)--Covidien (NYSE: COV, BSX: COV), 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 7082274 Monoject PreFillTM 10U/mL Heparin 7113214 Lock Flush Syringe, 10mL REF # 8881580123 7051524 Monoject PreFillTM 10U/mL Heparin 7113214 Lock Flush Syringe, 3mL REF # 8881580125 7051524 Monoject PreFillTM 10U/mL Heparin 7082274 Lock Flush Syringe 5mL 7113164 7113174 REF # 8881580300 7051444 Monoject PreFillTM 10U/mL Heparin Lock Flush Syringe 2.5mL in 3mL syringe REF # 8881581125 Monoject PreFillTM 10U/mL Heparin Lock Flush Syringe 5mL, with BLUNTIP plastic cannula
7082274 REF # 8881590121 7113064
Monoject PreFillTM 100U/mL Heparin Lock Flush Syringe 10mL
REF # 8881590123 7041194 Monoject PreFillTM 100U/mL Heparin 7072154
Lock Flush Syringe 3mL 7113034
8010194
REF # 8881590125 7041194 7102804 Monoject PreFillTM 100U/mL Heparin 7041204 7113034 Lock Flush Syringe 5mL 7051534 7113044 7051544 7113054 7051554 7113104 7071924 7113114 7072034 7113154 7072044 8010064 7072054 8010114 7072064 8010134 7072154 8010174 7082284
REF # 8881591125 7082284
Monoject PreFillTM 100U/mL Heparin
Lock Flush Syringe 5mL, with BLUNTIP plastic cannula
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.
ABOUT COVIDIEN LTD.
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in four segments: Medical Devices, Imaging Solutions, Pharmaceutical Products and Medical Supplies. With 2007 revenue of nearly $9 billion, Covidien has more than 43,000 employees worldwide in 57 countries, and its products are sold in over 130 countries. Please visit www.covidien.com to learn more about our business.
Contact:
Covidien Eric Kraus, 508-261-8305 Senior Vice President Corporate Communications eric.kraus@covidien.com or Coleman Lannum, CFA, 508-452-4343 Vice President Investor Relations cole.lannum@covidien.com or Bruce Farmer, 508-452-4372 Director Financial Communications bruce.farmer@covidien.com or Wayde McMillan, 508-452-4387 Director Investor Relations wayde.mcmillan@covidien.com
Source: Covidien
