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Terminated

CryoValve, Pulmonary Valve & Conduit SG

FDA Recall Z-0019-04 · Posted 2003-10-15

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2003-08-18
Date Terminated2003-10-15
Product Quantity1 unit

Reason for Recall

The heart valve procurement exceeded the warm ischemic time criteria.

Firm Action

The physician was notified by letter on 8/18/2002. The tissue was reported implanted on 4/08/2003.

Root Cause

Other

Distribution Pattern

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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