CryoValve, Aortic Valve
FDA Recall Z-0168-05 · Posted 2004-11-03
Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2004-05-06
Date Terminated2010-06-29
Product Quantity1 unit
Reason for Recall
CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.
Firm Action
Consignees were notified by letter on/about May 6, 2004.
Root Cause
Other
Distribution Pattern
Nationwide, Austria, Canada, Germany
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.