BEUDAMED
    FDA Recall Terminated

    ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-09-60-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use.

    Recall: Z-0934-05 · Initiated June 10, 2005

    Recall

    Recall Number
    Z-0934-05
    Event Number
    32459
    FEI Number
    2183870
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 10, 2005
    Posted
    June 25, 2005
    Terminated
    November 17, 2005
    Address
    Ev3 4600 Nathan Ln N, Plymouth, MN, 55442-2890

    Description

    ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-09-60-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use.

    Reason

    A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative.

    Action

    ev3 representative went to the 2 hospitals to retrieve affected product on 06/10/05, completed a Field Action Form and left a copy with the hospital.

    Distribution

    FL and PA

    Quantity

    1