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Terminated

CryoValve Heart Valve

FDA Recall Z-1188-03 · Posted 2003-08-29

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2003-04-01
Date Terminated2004-10-21
Product Quantity325 units

Reason for Recall

CryoLife initiated a retrospective review per FDA request, to insure that current regulatory guidelines for donor blood testing have been met for certain donors.

Firm Action

Consignees were notified by letter sent on various dates starting April, 2003 and were advised to provide the disposition of the tissue to CryoLife.

Root Cause

Other

Distribution Pattern

Tissues were distributed to hospitals and physicians located nationwide and worldwide.

Official Source

View FDA Recall →

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

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