Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm
FDA device recall Z-0600-06 · posted 2006-03-09 · Terminated
Recall details
- Recalling firm
- Cook, Inc.
- Reason for recall
- The side of the boxes give incorrect sizes for these stents. The label front is correct.
- Action taken
- Consignees were notified via telephone on 1/26/06 and a follow-up fax was sent.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 5
- Distribution
- California, Pennsylvania, Utah and Canada.
- Date initiated
- 2006-01-26
- Date posted
- 2006-03-09
- 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 |