FDA Device

CryoValve, Pulmonary Valve & Conduit

Hazard

A pre-implant swab culture of the aortic valve, which was procured from the same donor, was positive for Methicillin resistant Staphyococcus aureus.

What You Should Do

Remedy

The physician was notified by letter on 07/15/2004.

Products

CryoValve, Pulmonary Valve & Conduit
Brand
Cryolife Inc
UPC
Donor Number: 68668, Serial Number: 8037696, Model Number: PV00

Units Affected

1 tissue