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Terminated

CryoValve Allograft heart valve

FDA Recall Z-0675-03 · Posted 2003-03-21

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2003-01-23
Date Terminated2004-03-22
Product Quantity1 unit

Reason for Recall

An allograft associated with this donor has been linked to an alleged infection.

Firm Action

A CryoLife Technical Representative notified the consignee by telephone on/about 1/23/2003 to determine the disposition of the allograft. Allograft SID 7291867 (SGPV00) was located in storage at the St. Vincent''s Hospital, Indianapolis, IN. A CryoLife representative visited this site on 01/30/2003 to remove the allograft from inventory and return the tissue to CryoLife. After arrival at CryoLife on 02/03/2003, discard of the tissue was initiated following standard procedures for human tissue waste destruction

Root Cause

Other

Distribution Pattern

The unit was distributed to one Hospital facility in IN. There are no foreign or government accounts involved.

Official Source

View FDA Recall →

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

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