CryoValve, Pulmonary Valve & Conduit
FDA Recall Z-1524-2008 · Posted 2008-09-01
Recalling FirmCryoLife, Inc.
Recall StatusTerminated
Product CodeMIE
Date Initiated2008-03-26
Date Terminated2010-01-12
Product Quantity1 tissue
Reason for Recall
Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.
Firm Action
Hospitals were notified by letter on 3/24/2008. They were advised not to implanted the tissue and if implanted, they do not recommend explant unless medically necessary. A self addressed, stamped post card was included to confirm receipt of the notification. Serial number 8895391 was reported implanted. Serial number 8895131 was returned to CryoLife for destruction.
Root Cause
Material/Component Contamination
Distribution Pattern
Hospitals in DE, TN
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.