Biliary Stent Introducer Set
FDA device recall Z-0908-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Wilson-Cook Medical Inc
- Reason for recall
- The guiding catheter provided with the SIS-10 biliary stent introduction system may be a 5 French instead of the required 6 French guiding catheter.
- Action taken
- Consignees were notified on 4/21/2004 via visit by sales representative or fax to international distributor .
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 23 pieces
- Distribution
- MO, NY, PA, Australia, Israel and England
- Date initiated
- 2004-04-21
- Date posted
- 2004-07-20
- Date terminated
- 2004-08-17
- Location
- Winston Salem, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZIMMON BILIARY STENT SET (K851962) | Wilson-Cook Medical, Inc. | 1985-12-17 |