FDA Device

CryoValve Pulmonary Valve & Conduit.

Hazard

Microorganisms detected in associated allografts.

What You Should Do

Remedy

The medical facility was notified by letter on May 23, 2003. The implanting physician was notified by letter on May 28, 2003.

Products

CryoValve Pulmonary Valve & Conduit.
Brand
Cryolife Inc
UPC
Donor #64108, Serial #7984345, Model #PV00 and Donor #55416, Serial #7253418, Model #PV00.

Units Affected

2 individual heart valve allografts.