CryoValve, Aortic Valve & Conduit
Hazard
Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.
What You Should Do
Remedy
Hospitals were notified by letter on 3/24/2008. They were advised not to implanted the tissue and if implanted, they do not recommend explant unless medically necessary. A self addressed, stamped post card was included to confirm receipt of the notification. Serial number 8895391 was reported implanted. Serial number 8895131 was returned to CryoLife for destruction.
Affected by this recall?
Get a free legal consultation about this recall.
Talk to a Lawyer →Affiliate link
Products
CryoValve, Aortic Valve & Conduit
- Brand
- CryoLife, Inc.
- UPC
- Donor number 87732, Serial number 8895131
Units Affected
1 tissue