Date Initiated by Firm |
June 10, 2004 |
Date Posted |
July 27, 2004 |
Recall Status1 |
Terminated 3 on November 01, 2004 |
Recall Number |
Z-1162-04 |
Recall Event ID |
29300 |
PMA Number |
P020018 |
Product Classification |
System, Endovascular Graft, Aortic Aneurysm Treatment - Product Code MIH
|
Product |
Cook brand Reorder # PLVTW-14.0-38-30-BNS. Silhouette Transitionless Peel-Away Introducer |
Code Information |
Lot F1581379. |
Recalling Firm/ Manufacturer |
Cook, Inc. 750 Daniels Way Bloomington IN 47404-9120
|
For Additional Information Contact |
Customer Relations 800-457-4500
|
Manufacturer Reason for Recall |
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
|
FDA Determined Cause 2 |
Other |
Action |
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004. |
Quantity in Commerce |
5 |
Distribution |
Nationwide, Canada, Denmark and Japan. |
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.
|
PMA Database |
PMAs with Product Code = MIH and Original Applicant = COOK, INC.
|