| Date Initiated by Firm | March 26, 2008 |
|---|
| Date Posted | September 01, 2008 |
|---|
| Recall Status1 |
Terminated 3 on January 12, 2010 |
| Recall Number | Z-1524-2008 |
|---|
| Recall Event ID |
47517 |
| 510(K)Number | K033484 |
|---|
| Product Classification |
Allograft heart valve - Product Code MIE
|
| Product | CryoValve, Pulmonary Valve & Conduit |
|---|
| Code Information |
Donor number 87732, Serial number 8895391 |
Recalling Firm/
Manufacturer |
CryoLife, Inc.
1655 Roberts Blvd Nw
Kennesaw GA 30144-3632
|
| For Additional Information Contact | Bryan Brosseau
770-419-3355 |
|---|
Manufacturer Reason
for Recall | Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed. |
|---|
FDA Determined
Cause 2 | Material/Component Contamination |
|---|
| Action | 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. |
|---|
| Quantity in Commerce | 1 tissue |
|---|
| Distribution | Hospitals in DE, TN |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = MIE
|
|---|
