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Terminated

CryoValve, Pulmonary Valve & Conduit

FDA Recall Z-0298-05 · Posted 2004-12-08

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2004-07-28
Date Terminated2004-12-17
Product Quantity1 tissue

Reason for Recall

CryoLife received information stating that the tissue donation was deferred due to possible Hepaititis C suspected by the MD.

Firm Action

Consignee was notified verbally on 07/28/2004. The Allograft was retrieved and discarded.

Root Cause

Other

Distribution Pattern

MI

Official Source

View FDA Recall →

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

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