Recall Z-0707-06 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Ev3, Inc
ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization with Ethylene Oxide Gas. ev3, 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The self-expanding stent is made of nickel titanium alloy (Nitinol) and comes pre-mounted on an over-the-wire delivery system. The stent is cut from a nitinol tube into an open lattice design and is designed with tantalum radiopaque ma
| Date | Mar 18, 2006 (initiated Feb 27, 2006) |
| Status | Terminated |
| Reason | Mispackaging-Protege GPS SER6-9-60-125 devices were incorrectly packaged as SER6-7-80-135. Diameter is larger than expected. |
| Root cause | Other |
| Action | An ev3 field representative will notify affected consignees in person beginning 2/27/2006. Product retrieval or use of the device will be documented using on a ''Field Action Form''. Account credit or product from an unaffected lot number will be provided. |
| Quantity | 4 |
| Distribution | GA, OK and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011806 | PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY Sulzer Intratherapeutics, Inc., Sep 7, 2001 |