Recall Z-2170-2008 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Ev3, Inc
Ev3 Primus GPS Biliary Stent System 8 mm, 37 mm, B7, .40 mm, 5Fr, REF BXB35-08-37-75 Use before 2009-02 Sterile EO Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 Intended as a palliative treatment of malignant neoplasms in the biliary tree.
| Date | Aug 26, 2008 (initiated Apr 22, 2008) |
| Status | Terminated |
| Reason | A Primus GPS Biliary Stent System was mislabeled. The mislabeling resulted in a 8 mm diameter, 27 mm length stent being labeled as a 8 mm x 37 mm stent. |
| Root cause | Employee error |
| Action | The single affected consignee was visited by an ev3 representative to verify the use of the device or exchange it for an unaffected device. Information recorded on an ev3 Device Reconciliation Form. |
| Quantity | 1 Unit |
| Distribution | Nationwide Distribution --- state of NJ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043243 | PRIMUS STENT AND DELIVERY SYSTEM Ev3, Inc., Dec 9, 2004 |