| | Class 2 Device Recall Zilver |  |
| Date Initiated by Firm | January 26, 2006 |
|---|
| Date Posted | March 09, 2006 |
|---|
| Recall Status1 |
Terminated 3 on April 10, 2006 |
| Recall Number | Z-0600-06 |
|---|
| Recall Event ID |
34657 |
| 510(K)Number | K051124 |
|---|
| Product Classification |
Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
|
| Product | Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-8.0-40. |
|---|
| Code Information |
Lot 1557057. |
| FEI Number |
1820334
|
Recalling Firm/
Manufacturer |
Cook, Inc.
750 Daniels Way
Bloomington
IN
47404-9120
|
| For Additional Information Contact |
800-346-2686 |
|---|
Manufacturer Reason
for Recall | The side of the boxes give incorrect sizes for these stents. The label front is correct. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Consignees were notified via telephone on 1/26/06 and a follow-up fax was sent. |
|---|
| Quantity in Commerce | 5 |
|---|
| Distribution | California, Pennsylvania, Utah and Canada. |
|---|
| 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 = FGE
|
|---|
|
|
|
