| Date Initiated by Firm |
June 10, 2004 |
| Date Posted |
July 27, 2004 |
| Recall Status1 |
Terminated 3 on November 01, 2004 |
| Recall Number |
Z-1217-04 |
| Recall Event ID |
29300 |
| Product Classification |
System, Endovascular Graft, Aortic Aneurysm Treatment - Product Code MIH
|
| Product |
Cook brand Keller-Timmermans Introducer Set, curved with Rutner adapter includes: sheath 18.0 FR, 85 cm long without wire guide; VSSW-18.0-38-85-C-KTI. |
| Code Information |
Lots F1546696, F1559929 and F1566600. |
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 |
25 |
| 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.
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