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Terminated

CryoValve, Pulmonary Valve & Conduit

FDA Recall Z-0480-06 · Posted 2006-02-04

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2006-01-27
Date Terminated2006-04-04
Product Quantity1 unit

Reason for Recall

Additional serological testing performed after distribution indicates the donor has a past Hepatitis B infection.

Firm Action

Physicians were notified by letter on 1/27/2006.

Root Cause

Other

Distribution Pattern

NY

Official Source

View FDA Recall →

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

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