CryoValve, Aortic Valve and Conduit
FDA Recall Z-0686-05 · Posted 2005-04-06
Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2004-12-02
Date Terminated2010-06-28
Product Quantity1 tissue
Reason for Recall
An incorrect lot number was entered in the production record for the solution in which this allograft was packaged.
Firm Action
Consignee was notified by letter on 12/02/2004.
Root Cause
Other
Distribution Pattern
TN
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.