FDA Device

CryoValve, Pulmonary Valve & Conduit

Hazard

Additional serological testing performed after distribution indicates the donor has a past Hepatitis B infection.

What You Should Do

Remedy

Physicians were notified by letter on 1/27/2006.

Products

CryoValve, Pulmonary Valve & Conduit
Brand
Cryolife Inc
UPC
Donor number 78142, Serial number 8306247, Model number PV00

Units Affected

1 unit