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Terminated

CryoValve, Pulmonary Valve and Conduit

FDA Recall Z-1593-05 · Posted 2005-10-01

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2004-01-26
Date Terminated2005-10-06
Product Quantity1 tissue

Reason for Recall

Mislabeling; An allograft labeled as an aortic valve & conduit, actually contained a pulmonary valve and conduit.

Firm Action

Consignee was notified by letter on 01/26/2004. The tissue was returned to CryoLife and destroyed.

Root Cause

Other

Distribution Pattern

CA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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