Recall Z-0442-06 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Ev3, Inc
Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75
| Date | Jan 25, 2006 (initiated Aug 1, 2005) |
| Status | Terminated |
| Reason | A Primus device was labeled as a BXB 35 09-37-75 but contained a BXB35 07-27-75 stent. |
| Root cause | Other |
| Action | Notification was sent to ev3 Territory Managers to have them contact their customer, have them remove affected product from their shelves and place them aside. TheTerritory Manager is responsible for retreiving affected product and returning it to ev3. |
| Quantity | 18 devices |
| Distribution | AL, AZ, FL, KS, LA, MS, NC, NE, NY, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043243 | PRIMUS STENT AND DELIVERY SYSTEM Ev3, Inc., Dec 9, 2004 |