FDA Device

CryoValve Allograft, Aortic Valve & Conduit

Hazard

Donor of distributed allograft was diagnosed with dilated/ischemic cardiomyopathy.

What You Should Do

Remedy

The hospital was notified by letter on 5/05/2003.

Products

CryoValve Allograft, Aortic Valve & Conduit
Brand
Cryolife Inc
UPC
Donor #66810, Device Serial #8100262, Model #AV00

Units Affected

1 unit