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Terminated

CryoValve, Pulmonary Valve and Conduit

FDA Recall Z-0669-05 · Posted 2005-04-06

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2005-01-12
Date Terminated2005-04-12
Product Quantity1 tissue

Reason for Recall

During a retrospective review CryoLife's Medical Director identified pre-processing and incoming bioburden cultures of the heart tissue, which detected Staphylococcus aureas.

Firm Action

Consignee was notified by letter on 01/12/2005.

Root Cause

Other

Distribution Pattern

KS

Official Source

View FDA Recall →

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

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