Recall Z-0080-2007 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Cook, Inc.
Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-4.0-40.
| Date | Oct 28, 2006 (initiated Sep 21, 2006) |
| Status | Terminated |
| Reason | The side of the boxes give incorrect sizes for these stents. The label front is correct. (side label-5x40-front label-8x40) |
| Root cause | Other |
| Action | Consignees were notified via telephone on 9/21/06 and requested to return the recalled product. |
| Quantity | 5 |
| Distribution | Class II Recall - Worldwide distribution ---- USA including the states of Idaho and Indiana, as well as, the country of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051124 | ZILVER 635 BILIARY STENT Cook, Inc., Jul 12, 2005 |