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Terminated

CryoValve, Pulmonary Valve and Conduit

FDA Recall Z-0814-04 · Posted 2004-07-20

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2004-01-30
Date Terminated2004-04-15
Product Quantity1 unit

Reason for Recall

CryoLife was notified by the Tennessee Department of Health, that a recipient had contracted a Group A Streptococcus infection from orthopedic tissue originating from the same donor as CryoLife donor 69347.

Firm Action

The consignee was contacted by telephone by the CryoLife Medical Director on 01/30/2004.

Root Cause

Other

Distribution Pattern

The tissue was distributed to one physician in IN.

Official Source

View FDA Recall →

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

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