FDA Device

CryoValve Allograft heart valve

Hazard

An allograft associated with this donor has been linked to an alleged infection.

What You Should Do

Remedy

A CryoLife Technical Representative notified the consignee by telephone on/about 1/23/2003 to determine the disposition of the allograft. The allograft SID 72552025 (V00) was located in storage at the SUNY University Hospital, Syracuse, NY. The CryoLife representative visited this site on 01/30/2003 to remove the allograft from inventory and return the tissue to CryoLife. After arrival at CryoLife on 02/03/2003, discard of the tissue was initiated following standard procedures for human tissue waste destruction.

Products

CryoValve Allograft heart valve
Brand
Cryolife Inc
UPC
Model number PV00, Serial Number: 7255205, Donor #56190

Units Affected

1 unit