| |
Class 3 Device Recall |
 |
| Date Initiated by Firm |
September 26, 2005 |
| Date Posted |
January 10, 2006 |
| Recall Status1 |
Terminated 3 on January 10, 2006 |
| Recall Number |
Z-0368-06 |
| Recall Event ID |
33700 |
| Product Classification |
Device, Vascular, For Promoting Embolization - Product Code KRD
|
| Product |
Cook brand Embolization Coils, stainless steel, sterile, 20 MM diameter, .038'' (0.97 mm) diameter embolus, 20 MM diameter, 20 MM long For use with .038'' end hole; Reorder # MWCE-38-20-20. |
| Code Information |
Lots F512190X, F612598, F712671, F782158, F1015070, F1246233, F1296872, F1306174, F1324630, F1333380, F1345472, F1395273 and F1479165. |
Recalling Firm/
Manufacturer |
Cook, Inc.
750 Daniels Way
Bloomington IN 47404-9120
|
| For Additional Information Contact |
800-346-2686
|
Manufacturer Reason
for Recall |
The coil is 20 centimeters in length, but the label states the length is 20 millimeters.
|
FDA Determined
Cause 2 |
Other |
| Action |
Consignees were notified via telephone and recall letter dated September 26, 2005. |
| Quantity in Commerce |
242 |
| Distribution |
Delaware, New York and Pennsylvania. |
| 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.
|
|
|
|
