CryoValve, Pulmonary Valve & Conduit
- Company
- Cryolife Inc
- Recall Initiated
- March 26, 2008
- Posted
- September 1, 2008
- Terminated
- January 12, 2010
- Recall Number
- Z-1524-2008
- Quantity
- 1 tissue
- Firm Location
- Kennesaw, GA
Reason for Recall
Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.
Distribution
Hospitals in DE, TN
Lot / Code Info
Donor number 87732, Serial number 8895391
Root Cause
Material/Component Contamination
Action Taken
Hospitals were notified by letter on 3/24/2008. They were advised not to implanted the tissue and if implanted, they do not recommend explant unless medically necessary. A self addressed, stamped post card was included to confirm receipt of the notification. Serial number 8895391 was reported implanted. Serial number 8895131 was returned to CryoLife for destruction.
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