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 markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predete
Hazard
Mispackaging-Protege GPS SER6-9-60-125 devices were incorrectly packaged as SER6-7-80-135. Diameter is larger than expected.
What You Should Do
Remedy
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.
Affected by this recall?
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Products
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
- UPC
- Lot 1211723, expiration date Nov 2007
Units Affected
4