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Terminated

CryoValve, Pulmonary Valve & Conduit

FDA Recall Z-0026-05 · Posted 2004-10-20

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2004-07-15
Date Terminated2007-12-31
Product Quantity1 tissue

Reason for Recall

A pre-implant swab culture of the aortic valve, which was procured from the same donor, was positive for Methicillin resistant Staphyococcus aureus.

Firm Action

The physician was notified by letter on 07/15/2004.

Root Cause

Other

Distribution Pattern

The tissue was shipped 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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