Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 6.0 mm, stent length
FDA device recall Z-0391-06 · posted 2006-01-13 · Terminated
Recall details
- Recalling firm
- Cook, Inc.
- Reason for recall
- The side of the box gives the size of the stent as 8 x 60 instead of the actual size of 6 x 60. The label front is correct.
- Action taken
- Consignees were notified of the initial recall by phone beginning on 10/24/05 and of the extension to the second product on 01/06 /06.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 9
- Distribution
- Connecticut, Michigan, Minnesota, Montana, Nevada, Pennsylvania, Utah, Wisconsin and Canada.
- Date initiated
- 2005-10-24
- Date posted
- 2006-01-13
- Date terminated
- 2006-04-10
- Location
- Bloomington, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZILVER 635 BILIARY STENT (K051124) | Cook, Inc. | 2005-07-12 |