Recall Z-1181-03 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Wilson-Cook Medical Inc
Zilver Expandable Metal Biliary Stent
| Date | Aug 26, 2003 (initiated Jan 8, 2002) |
| Status | Terminated |
| Reason | The inner catheter of the introducer system may break after stent deployment. |
| Root cause | Other |
| Action | 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. |
| Quantity | 57 units |
| Distribution | The product was distributed to hospitals located nationwide and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020788 | WILSON-COOK ZILVER BILIARY STENT Wilson-Cook Medical, Inc., May 8, 2002 |