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Terminated

CryoValve Allograft, Heart valve

FDA Recall Z-0866-03 · Posted 2003-05-22

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2003-04-30
Date Terminated2004-04-29
Product Quantity8 units

Reason for Recall

Microorganisms were detected in associated allografts.

Firm Action

Implanting physicians were notified via letter on April 30, 2003. They were advised to quarantine and return the allograft if not implanted. A self addressed, stamped postcard was included to affirm receipt of the notice and to provide information of final disposition of the allograft.

Root Cause

Other

Distribution Pattern

The components were distributed to hospitals and physicians located in CA, IL IN, , NM, OH and OK.

Official Source

View FDA Recall →

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

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