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-0080-2007 · posted 2006-10-28 · 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. (side label-5x40-front label-8x40)
- Action taken
- Consignees were notified via telephone on 9/21/06 and requested to return the recalled product.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 5
- Distribution
- Class II Recall - Worldwide distribution ---- USA including the states of Idaho and Indiana, as well as, the country of Canada
- Date initiated
- 2006-09-21
- Date posted
- 2006-10-28
- Date terminated
- 2007-04-04
- 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 |