Recall Z-0908-04 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Wilson-Cook Medical Inc
Biliary Stent Introducer Set
| Date | Jul 20, 2004 (initiated Apr 21, 2004) |
| Status | Terminated |
| Reason | The guiding catheter provided with the SIS-10 biliary stent introduction system may be a 5 French instead of the required 6 French guiding catheter. |
| Root cause | Other |
| Action | Consignees were notified on 4/21/2004 via visit by sales representative or fax to international distributor . |
| Quantity | 23 pieces |
| Distribution | MO, NY, PA, Australia, Israel and England |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K851962 | ZIMMON BILIARY STENT SET Wilson-Cook Medical, Inc., Dec 17, 1985 |