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Terminated

CryoValve, Conduit and Pulmonary Valve and Conduit

FDA Recall Z-1484-04 · Posted 2004-09-23

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2004-04-12
Date Terminated2005-05-10
Product Quantity1 tissue

Reason for Recall

CryoLife received information regarding a positive culture for Group A Streptococcus infection in a recipient of tissue procured from the attached donor.

Firm Action

Consignee was notified via telephone on 4/12/2004. The tissue was returned and destroyed.

Root Cause

Other

Distribution Pattern

NM

Official Source

View FDA Recall →

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

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