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Terminated

CryoValve, Pulmonary Valve & Conduit

FDA Recall Z-0580-05 · Posted 2005-03-10

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2004-12-17
Date Terminated2006-01-27
Product Quantity1 tissue

Reason for Recall

Records noted that the infant donor's mother had tested positive for Hepatitis B.

Firm Action

Physicians were notified by letter on 12/17/2004.

Root Cause

Other

Distribution Pattern

CA, FL

Official Source

View FDA Recall →

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

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