Recall Z-0391-06 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Cook, Inc.
Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 6.0 mm, stent length 60 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-6.0-60.
| Date | Jan 13, 2006 (initiated Oct 24, 2005) |
| Status | Terminated |
| Reason | The side of the box gives the size of the stent as 8 x 60 instead of the actual size of 6 x 60. The label front is correct. |
| Root cause | Other |
| Action | Consignees were notified of the initial recall by phone beginning on 10/24/05 and of the extension to the second product on 01/06 /06. |
| Quantity | 9 |
| Distribution | Connecticut, Michigan, Minnesota, Montana, Nevada, Pennsylvania, Utah, Wisconsin and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051124 | ZILVER 635 BILIARY STENT Cook, Inc., Jul 12, 2005 |