BEUDAMED
    FDA Recall Terminated

    EBI VueCath Endoscopic Spinal System

    Recall: Z-1006-03 · Initiated June 17, 2003

    Recall

    Recall Number
    Z-1006-03
    Event Number
    26512
    FEI Number
    2242816
    Product Code
    GWG
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    June 17, 2003
    Posted
    July 15, 2003
    Terminated
    December 31, 2003
    Address
    EBI, L.P. 100 Interpace Parkway, Parsippany, NJ, 07054-1079

    Description

    EBI VueCath Endoscopic Spinal System

    Reason

    Non sterile device is labeled sterile.

    Action

    The firm notified their customers via a field correction letter dated June 17, 2003. Instructions given are to sterilize the unit prior to use. A EBI field representative will be visiting to replace the boxes.

    Distribution

    Hospitals, clinics, and doctors nationwide.

    Quantity

    39