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Terminated

CryoValve Pulmonary Valve & Conduct

FDA Recall Z-0167-04 · Posted 2003-11-27

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2003-11-04
Date Terminated2004-05-06
Product QuantityOne unit

Reason for Recall

CryoLife received information that an allograft associated with the donor had been linked to a complaint of an alleged positive pre-implant culture. Specifically Clostridium baratii was detected on the pre-implant culture performed at the implanting hospital site.

Firm Action

Consignee was notified by letter on 11/4/2003. The tissue was reported implanted on 10/14/2003. The letter was intended to provide the hospital with a basis to determine if any additional patient surveillance or intervention is necessary. A self addressed, stamped postcard was enclosed to verify receipt of notification.

Root Cause

Other

Distribution Pattern

The tissue was shipped to one hospital in MO.

Official Source

View FDA Recall →

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

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