FDA Device

Heart-valve, allograft

Hazard

Donor of aortic valve had procurement cultures that were positive for E-coli.

What You Should Do

Remedy

A CryoLife representative contacted the consignee by telephone on 2/4/2002 to inform her of the recall action. The graft was returned to CryoLife and destroyed on/about 2/11/2003.

Products

Heart-valve, allograft
Brand
Cryolife Inc
UPC
Donor #60741, Model #SGAV10, Serial #783013

Units Affected

1 unit