Recall Z-0113-2009 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Cook Endoscopy
Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm, Stent Length: 6cm, Introduction System: 7 FR., Disposable-Single Use Only, Rx Only, Cook GI Endoscopy, Winston-Salem, NC. The device is used in palliation neoplasms in the biliary tree.
| Date | Oct 14, 2008 (initiated Sep 11, 2008) |
| Status | Terminated |
| Reason | A section of the introduction system may detach after the stent has deployed. |
| Root cause | Process control |
| Action | The consignee was notified by letter on/about 09/11/2008. The distributor was instructed to contact their customers and coordinate the return of all affected product to Cook Endoscopy. A responds form was attached to the letter to be completed and returned to Cook Medical to confirm receipt of notification and indicate quantity to be returned. Contact Cook Endoscopy at 1-336-744-0157, ext. 6325 for assistance. |
| Quantity | 12 |
| Distribution | USA: IL and OUS: China |
| 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 |