FDA Device

Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75

Hazard

A Primus device was labeled as a BXB 35 09-37-75 but contained a BXB35 07-27-75 stent.

What You Should Do

Remedy

Notification was sent to ev3 Territory Managers to have them contact their customer, have them remove affected product from their shelves and place them aside. TheTerritory Manager is responsible for retreiving affected product and returning it to ev3.

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Products

Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75
UPC
Lot no. 923291, 923290

Units Affected

18 devices

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