Recall Z-0600-06 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 # ZIB6-80-8.0-40.
| Date | Mar 9, 2006 (initiated Jan 26, 2006) |
| Status | Terminated |
| Reason | The side of the boxes give incorrect sizes for these stents. The label front is correct. |
| Root cause | Other |
| Action | Consignees were notified via telephone on 1/26/06 and a follow-up fax was sent. |
| Quantity | 5 |
| Distribution | California, Pennsylvania, Utah 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 |