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More Heparin Products Recalled
May 7, 2008
Medtronic, Inc., a maker of medical devices for heart patients, today announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda Bioactive surface. The affected medical devices are disposable products used during heart surgeries for a procedure called cardiopulmonary bypass and include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. This recall is being issued in response to the FDA’s April 2008 recommendation to device manufacturers that heparin supplies be checked with newly-developed tests, and that affected products be evaluated for possible field corrective action.
Limited lots of Carmeda-coated products were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS), an animal-derived chemical used to treat arthritis. Although the patient risk associated with the presence of OSCS in heparin-coated medical devices is unknown at this time, the FDA has received numerous reports of serious injury and death in patients who have been injected with heparin products containing high levels of OSCS.
Baxter International Inc., which distributes most of the heparin products used in the U.S., was the first company to issue a heparin recall. In January 2008, Baxter recalled 9 types of multi-dose heparin vials after reports of severe allergic reactions to the drug began to surface. On February 29, 2008, after scientists discovered that certain lots of Chinese-sourced heparin were contaminated with a foreign substance now known to be OSCS, Baxter expanded the recall to include all Baxter heparin products.
After the Baxter heparin recalls, similar recalls were issued by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France, Germany, and Japan. The FDA announced that, all together, tainted heparin has been found in 11 countries from 12 Chinese sources. Now, additional American heparin suppliers have issued precautionary recalls, with the latest U.S. heparin recall coming from Medtronic.
Contaminated heparin products pose a risk of causing severe allergic reactions, which can be life-threatening. To date, the FDA has received reports of more than 90 deaths and 1,000 adverse events associated with patients in the U.S. who had one or more allergic reactions to heparin. At least 3 deaths in the U.S. have been directly linked to contaminated heparin.
If you have suffered an allergic reaction because of contaminated Heparin, please contact us today as you may be entitled to compensation for your injuries.
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