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Terminated

CryoValve, Conduit and Pulmonary Valve

FDA Recall Z-1135-04 · Posted 2004-07-22

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2004-07-01
Date Terminated2004-09-03
Product Quantity1 unit

Reason for Recall

The sterilization cycle for the instruments used during the procurement of the tissue from the donor had expired.

Firm Action

The physicians were notified by letter on 07/01/2004. Both tissues were reported implanted.

Root Cause

Other

Distribution Pattern

CA, TX

Official Source

View FDA Recall →

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

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