FDA Device

CryoValve, Pulmonary Valve & Conduit

Hazard

Records noted that the infant donor's mother had tested positive for Hepatitis B.

What You Should Do

Remedy

Physicians were notified by letter on 12/17/2004.

Products

CryoValve, Pulmonary Valve & Conduit
Brand
Cryolife Inc
UPC
Donor #62654, Serial #7816169, Model #PV00

Units Affected

1 tissue