CryoValve, Aortic Valve & Conduit
FDA Recall Z-0776-04 · Posted 2004-07-20
Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2004-02-20
Date Terminated2005-02-10
Product Quantity1 unit
Reason for Recall
Microorganisms were detected in donor tissue associated with this allograft, specifically Aeormonas hydrophila.
Firm Action
Consignee was notified first by telephone on 02/20/2004, then with follow up letter on 04/02/2004.
Root Cause
Other
Distribution Pattern
This tissue was distributed to one physician in CA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.