Recall Z-0089-04 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Wilson-Cook Medical Inc
ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent Length: 6 CM., Accepts .035'' Wire Guide, Introduction system: 7 FR., Minimum Scope Channel: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
| Date | Nov 6, 2003 (initiated Aug 21, 2002) |
| Status | Terminated |
| Reason | Complaints were reported of difficulty in stent deployment. |
| Root cause | Other |
| Action | Sales representatives were sent notices via email on April 21, 2002. They were responsible for visiting each of their accounts, inform them of the Market Withdrawal and to return the device for replacement. |
| Quantity | 155 units |
| Distribution | The device was distributed nationwide, Ireland and Jordan. |
| 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 |