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Terminated

Aortic Valve & Conduit

FDA Recall Z-0842-2007 · Posted 2007-06-07

Recalling FirmCryoLife, Inc.
Recall StatusTerminated
Product CodeMIE
Date Initiated2007-04-17
Date Terminated2007-12-31
Product Quantity1 tissue

Reason for Recall

Donor tissue was released prior to information received regarding a pericardial effusion.

Firm Action

Both physicians were contacted by telephone on 4/17 & 18/2007. Both tissues were returned to CryoLife

Root Cause

Other

Distribution Pattern

AZ, CO

Official Source

View FDA Recall →

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

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