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Covidien, formerly Tyco Healthcare, has recalled 32 lots of Heparin after being notified by its supplier, Scientific Protein Laboratories LLC, that certain lots may be contaminated. Although Covidien states that it has not received any reports of adverse reactions to the drug, it is working with the U.S. Food and Drug Administration (FDA) on the voluntary recall.

Details of the recall

Massachusetts and Bermuda based Covidien stated that the following 32 lots of Heparin Sodium USP are being recalled due to possible contamination:

• Monoject PreFill(TM) 10U/mL Heparin Lock Flush Syringe, 10mL Lot numbers: 7082274, 7113214
• Monoject PreFill(TM) 10U/mL Heparin Lock Flush Syringe, 3mL Lot numbers: 7051524, 7113214
• Monoject PreFill(TM) 10U/mL Heparin Lock Flush Syringe 5mL Lot numbers: 7113174, 7051524, 7113164, 7082274
• Monoject PreFill(TM) 10U/mL Heparin Lock Flush Syringe 2.5mL in 3mL syringe Lot number: 7051444
• Monoject PreFill(TM )10U/mL Heparin Lock Flush Syringe 5mL, with BLUNTIP plastic cannula Lot number: 7082274
• Monoject PreFill(TM) 100U/mL Heparin Lock Flush Syringe 10mL Lot number: 7113064
• Monoject PreFill(TM) 100U/mL Heparin Lock Flush Syringe 3mL Lot numbers: 7113034, 8010194, 7041194, 7072154
• Monoject PreFill(TM) 100U/mL Heparin Lock Flush Syringe 5mL Lot numbers: 7051534, 7113044, 7051544, 7113054, 7051554, 7113104, 7071924 7113114, 7072034, 7113154, 7072044, 8010064, 7072054, 8010114, 7072064, 8010134, 7072154, 8010174, 7082284, 7113034, 7041204, 7041194, 7102804
• Monoject PreFill(TM) 100U/mL Heparin Lock Flush Syringe 5mL, with BLUNTIP plastic cannula Lot number: 7082284

Covidien joins Baxter Healthcare, B. Braun and AM2PAT in its recall of raw Heparin allegedly produced in China.

FDA Has Received Reports of Serious Injury / Death

According to a press release from the FDA’s website, www.fda.gov/oc/po/firmrecalls/covidien03_08.html, “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.”

If you’ve been injured due to Heparin use, contact an attorney to discuss your situation. The consultation is free and without obligation. To contact a qualified attorney whose practice focuses in this area of law, please click here.