|
Class 2 Device Recall |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
December 17, 2004 |
Date Posted |
April 06, 2005 |
Recall Status1 |
Terminated 3 on June 01, 2005 |
Recall Number |
Z-0684-05 |
Recall Event ID |
31140 |
Product Classification |
Heart-Valve, Allograft - Product Code MIE
|
Product |
CryoValve, Pulmonary Valve and Conduit |
Code Information |
Donor #65989, Serial #8095375, Model #PV00 |
Recalling Firm/ Manufacturer |
Cryolife Inc 1655 Roberts Blvd Nw Kennesaw GA 30144-3632
|
For Additional Information Contact |
Mr. P. Tyler Cochran, CQA, CTBS 770-419-3355
|
Manufacturer Reason for Recall |
During a retrospective review, CryoLife noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the 'Last Seen Alive' time in their calculation.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by letters dated 12/17/2004, 01/03/2005 and 01/19/2005. |
Quantity in Commerce |
1 tissue |
Distribution |
CA, NJ, TX |
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.
|
|
|
|