FDA Orders Recall of CryoLife Tissue

The US Food and Drug Administration (FDA) has ordered CryoLife, Inc. (Kennesaw, GA, USA) to recall distributed human tissue processed from October 3, 2001, to the present. Under the order, the company must also withhold from the market or destroy all soft tissue processed after that date. This includes tendons, ligaments, and cartilage. CryoLife is the largest US processor of donated human tissue from cadavers. The tissue is used to repair knees and other joints in elective surgery.

The FDA is taking this action because it has determined that CryoLife cannot ensure that the human tissue it processes for transplantation is free from fungal and bacterial contaminants. Tissue from a donor processed by CryoLife on and after October 3, 2001, has been associated with the November 7, 2001, death of a US patient who received a soft tissue implant during reconstructive knee surgery. Also, 27 other people have developed serious infections following tissue implants processed by CryoLife. A similar recall may also be made of heart valves processed by the company, says the FDA.

The FDA had issued a warning letter to CryoLife on June 17, 2002, after determining that the firm had not adequately investigated its validation of processing and testing methods nor implemented recommendations from the US Centers for Disease Control and Prevention (CDC), or any other procedures, to ensure that tissue processed by the firm was not contaminated.

If a bacterial or fungal infection were to occur following a tissue transplant, the signs and symptoms would usually appear within days to weeks after transplantation, notes the FDA. Therefore, it is unlikely that patients who have not recently received a transplant are likely to be at future risk.





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