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Terminated

CryoValve Pulmonary Valve and Conduit

FDA Recall Z-0548-04 · Posted 2004-02-25

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2003-12-10
Date Terminated2004-07-23
Product Quantity1 unit

Reason for Recall

As part of this ongoing retrospective review, CryoLife has identified a donor who does not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

Firm Action

The consignee was notified by letter on 12/10/2003. CryoLife received confirmation of receipt of the notification from the physician who reported the tissue was implanted on 04/17/1997.

Root Cause

Other

Distribution Pattern

The allograft was shipped to one physician in TX.

Official Source

View FDA Recall →

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

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