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Ancient volcano caused 10-year winter
Thursday, July 9
The FDA said limited lots of the medical products, manufactured by the Atrium Medical Corp., were produced with heparin found contaminated with oversulfated chondroitin sulfate, or OSCS, that might present a health risk. The agency said it received reports of serious injury and death in patients administered injectable heparin products containing high levels of OSCS.
While Atrium's Hydraglide catheters don't contain high levels of heparin, there still is a risk of patients being exposed to OSCS, officials said.
Customers can obtain replacement catheters from Atrium or contact the company at 800-528-7486 for additional information.