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CryoLife to appeal FDA order

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Posted 11:36AM on Thursday 15th August 2002 ( 22 years ago )
WASHINGTON - A Georgia tissue bank says it will appeal the government&#39;s order to stop selling its cadaver tissue because its products have been linked to a death and serious infections. <br> <br> Federal officials say Kennesaw-based CryoLife Incorporated can not guarantee the tissues are free of fungus or bacteria. <br> <br> Wednesday&#39;s action by the Food and Drug Administration comes after months of failed inspections and negotiations with the company. <br> <br> CryoLife is awaiting a hearing to appeal the FDA&#39;s order. Meanwhile, it has quarantined all its donated soft tissue while <br> <br> The FDA ordered CryoLife to recall all the soft tissue such as cartilage and tendons that it has processed since October third. That&#39;s a month before a 23-year-old Minnesota man died from a bacterial infection linked to CryoLife cartilage that he received during reconstructive knee surgery.

http://accesswdun.com/article/2002/8/191298

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