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Terminated

CryoValve, Pulmonary Valve & Conduit

FDA Recall Z-0774-04 · Posted 2004-07-20

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2004-03-24
Date Terminated2005-01-19
Product Quantity1 unit

Reason for Recall

The donor of the tissue had a viral syndrome at the time of death.

Firm Action

Consignees were notified by letter on 3/24/2004.

Root Cause

Other

Distribution Pattern

CT, PA

Official Source

View FDA Recall →

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

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