Recall Z-0935-05 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Ev3
ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-08-20-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use.
| Date | Jun 25, 2005 (initiated Jun 10, 2005) |
| Status | Terminated |
| Reason | A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative. |
| Root cause | Other |
| Action | ev3 representative went to the 2 hospitals to retrieve affected product on 06/10/05, completed a Field Action Form and left a copy with the hospital. |
| Quantity | 1 |
| Distribution | FL and PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033314 | PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM Ev3, Inc., Nov 21, 2003 |