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Terminated

CryoValve Allograft, Aortic Valve & Conduit

FDA Recall Z-0988-03 · Posted 2003-07-10

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2003-05-05
Date Terminated2003-07-10
Product Quantity1 unit

Reason for Recall

Donor of distributed allograft was diagnosed with dilated/ischemic cardiomyopathy.

Firm Action

The hospital was notified by letter on 5/05/2003.

Root Cause

Other

Distribution Pattern

Unit was distributed to one hospital in CA.

Official Source

View FDA Recall →

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

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