BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0442-06 · Initiated August 1, 2005

    Recall

    Recall Number
    Z-0442-06
    Event Number
    34352
    FEI Number
    2183870
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 1, 2005
    Posted
    January 25, 2006
    Terminated
    December 31, 2006
    Address
    Ev3 Inc 4600 Nathan Ln N, Plymouth, MN, 55442-2890

    Description

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

    Reason

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

    Action

    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.

    Distribution

    AL, AZ, FL, KS, LA, MS, NC, NE, NY, TX

    Quantity

    18 devices