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Terminated

CryoValve, Synegraft Pulmonary Valve & Conduit

FDA Recall Z-1038-03 · Posted 2003-07-22

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2003-07-10
Date Terminated2004-05-12
Product Quantity1 tissue

Reason for Recall

Human tissue for transplantation, which was associated with a donor whose pre-processing culture detected microorganisms, was distributed.

Firm Action

The physician was notified by letter on 7/10/2003.

Root Cause

Other

Distribution Pattern

The tissue was distributed to one physician in CA.

Official Source

View FDA Recall →

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

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