FDA Device

CryoValve, Pulmonary Valve & Conduit

Hazard

Donor tissue was released prior to information received regarding a pericardial effusion.

What You Should Do

Remedy

Both physicians were contacted by telephone on 4/17 & 18/2007. Both tissues were returned to CryoLife

Products

CryoValve, Pulmonary Valve & Conduit
Brand
CryoLife, Inc.
UPC
Donor number 87980, Serial number 8897314, Model Number PV00

Units Affected

1 tissue