CryoValve, Pulmonary Valve and Conduit
FDA Recall Z-0684-05 · Posted 2005-04-06
Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2004-12-17
Date Terminated2005-06-01
Product Quantity1 tissue
Reason for Recall
During a retrospective review, CryoLife noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the 'Last Seen Alive' time in their calculation.
Firm Action
Consignees were notified by letters dated 12/17/2004, 01/03/2005 and 01/19/2005.
Root Cause
Other
Distribution Pattern
CA, NJ, TX
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.