Recall Z-0008-05 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Ev3
Biliary Stent System (6Fr 9mm x 30mm).
| Date | Oct 5, 2004 (initiated Sep 1, 2004) |
| Status | Terminated |
| Reason | A customer complaint received indicated that a Protg stent, PN SERB65-09-30-120 was found in a pouch that was not properly sealed. The Protg GPS Stent System is 'double barrier' packaged and consists of a sealed inner tray in a sealed pouch. The pouch seal ensures sterility of the external surface of the inner tray. The inner tray seal containing the device was not affected. |
| Root cause | Other |
| Action | A recall notification letter dated September 01, 2004 was sent to customers. Customers are to retain product until pick up by Ev3 sales representatives. |
| Quantity | 5 systems |
| Distribution | South Carolina, North Carolina, and Texas. |
| 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 |