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Terminated

Heart-valve, allograft

FDA Recall Z-1187-03 · Posted 2003-08-28

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2003-02-04
Date Terminated2003-08-28
Product Quantity1 unit

Reason for Recall

Donor of aortic valve had procurement cultures that were positive for E-coli.

Firm Action

A CryoLife representative contacted the consignee by telephone on 2/4/2002 to inform her of the recall action. The graft was returned to CryoLife and destroyed on/about 2/11/2003.

Root Cause

Other

Distribution Pattern

Allograft was distrbuted to one medical facility in CA. No government or foreign accounts involved.

Official Source

View FDA Recall →

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

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