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Terminated

CryoValve, Pulmonary Heart Valve

FDA Recall Z-0065-04 · Posted 2003-10-24

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2003-09-25
Date Terminated2004-05-06
Product Quantity1 unit

Reason for Recall

Additional information obtained from the Outside Tissue Procurement Organization indicated that the donor's attending physician stated that the patient had pneumonia and it possibly might have been a systemic infection.

Firm Action

The implanting physician was notified by letter on 9/25/2003. The tissue was reported implanted therefore notification was intended to provide the physician with a basis to determine if any additional patient surveillance or intervention is necessary. A self addressed stamped postcard was enclosed to affirm receipt of notification.

Root Cause

Other

Distribution Pattern

The tissue was distributed to one physician in CA.

Official Source

View FDA Recall →

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

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