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Terminated

CryoValve Conduit and Pulmonary Valve and Conduit

FDA Recall Z-0855-04 · Posted 2004-07-20

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2004-02-25
Date Terminated2004-09-14
Product Quantity1 unit

Reason for Recall

A retrospective review of donor files conducted by CryoLife revealed an expired solution had been used during processing of the associated tissues.

Firm Action

Consignees were notified by letter on 03/02/2004.

Root Cause

Other

Distribution Pattern

CA

Official Source

View FDA Recall →

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

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