Spiral Z Expandable Metal Biliary Stent
FDA device recall Z-1179-03 · posted 2003-08-26 · Terminated
Recall details
- Recalling firm
- Wilson-Cook Medical Inc
- Reason for recall
- The inner catheter of the introducer system may break after stent deployment.
- Action taken
- Initially the firm conducted a Market Withdrawal on January 8, 2002. Subsequently the firm initiated a recall, notifying consignees via letter on 8/8/2003. A Customer Response Form was attached.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 23 units
- Distribution
- The product was distributed to hospitals located nationwide and worldwide.
- Date initiated
- 2002-01-08
- Date posted
- 2003-08-26
- Date terminated
- 2005-03-21
- 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 |
|---|---|---|
| WILSON-COOK GIANTURCO-ROSCH Z-STENT AND INTRODUCER (K941350) | Wilson-Cook Medical, Inc. | 1995-03-09 |