Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SER6-10-30-135 (.018) (Biliary)
Hazard
Ev3 had received customer complaints indicating that the stent device could not be used with an .035' guidewire. An investigation found that 6Fr, 135 cm (.018') stent system were labeled as a 120 cm (.035') stent system and that 6Fr 120 cm (.035') were labeled as 6Fr, 135 cm (.018').
What You Should Do
Remedy
Send notification letter to direct accounts and an EV3 representative will contact the direct account within the next few days to arrrange for the return of all unused product.
Affected by this recall?
Get a free legal consultation about this recall.
Talk to a Lawyer →Affiliate link
Products
Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SER6-10-30-135 (.018) (Biliary)
- UPC
- Lot # 672655
Units Affected
10