CryoValve Allograft, Pulmonary Heart valve & Conduit.
FDA Recall Z-0861-03 · Posted 2003-05-22
Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2003-05-05
Date Terminated2003-07-17
Product Quantity1 unit
Reason for Recall
Microorganisms were detected in associated allografts after initial release of donor.
Firm Action
The implanting physician was notified via letter on May 5, 2003. Allograft was reported implanted 1/17/2003.
Root Cause
Other
Distribution Pattern
Allograft was distributed to and implanted by one physician in California.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.