BEUDAMED
    FDA Recall Terminated

    Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12 treatment kit box labeled as Buffered Iontophoretic Delivery Electrode System Treatment Kit, 12 treatments.

    Recall: Z-0799-05 · Initiated March 15, 2005

    Recall

    Recall Number
    Z-0799-05
    Event Number
    31453
    Firm
    Selectivemed Components Inc
    FEI Number
    1000136007
    Product Code
    EGJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 15, 2005
    Posted
    May 6, 2005
    Terminated
    July 21, 2007
    Address
    564 Harcourt Rd, Mount Vernon, OH, 43050-3920

    Description

    Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12 treatment kit box labeled as Buffered Iontophoretic Delivery Electrode System Treatment Kit, 12 treatments.

    Reason

    The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed.

    Action

    The recalling firm sent a recall letter, dated 3/15/05 to their consignee.

    Distribution

    The recalling firm distributed the product to one consignee (distributor): North Coast Medical Inc., 18305 Sutter Blvd., Morgan Hill, CA 95037.

    Quantity

    2600 units.