BEUDAMED
    FDA Recall Terminated

    Olsen Medical, MIDAS TOUCH NEEDLE ELECTRODE, WITH MODIFIED TIP. Model Numbers: 30-1011, 30-1012, 30-1013, 30-1014 and 30-6011.

    Recall: Z-0140-2010 · Initiated September 24, 2009

    Recall

    Recall Number
    Z-0140-2010
    Event Number
    53482
    Firm
    Kentucky Packaging Service LP
    FEI Number
    3000719969
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 24, 2009
    Posted
    November 10, 2009
    Terminated
    October 5, 2010
    Address
    3001 W Kentucky St, Louisville, KY, 40211-1505

    Description

    Olsen Medical, MIDAS TOUCH NEEDLE ELECTRODE, WITH MODIFIED TIP. Model Numbers: 30-1011, 30-1012, 30-1013, 30-1014 and 30-6011.

    Reason

    THERE WERE INCONSISTENCIES NOTICED ON THE INSULATION OVERLAP. THE ELECTRODE HAS A LARGE DIAMETER SHAFT THAT TRANSITIONS TO A SMALLER DIAMETER SHAFT. THE 1ST LAYER OF INSULATION WHICH COVERS THE SMALL DIAMETER SHAFT OVERLAPS WITH THE 2ND LAYER OF INSULATION THAT COVERS THE LARGER DIAMETER SHAFT. ON SOME ELECTRODES IT APPEARS THAT THE OVERLAP IS TOO SHORT TO COVER THE TRANSITION WHICH MAKES THIS

    Action

    Olsen Medical issued an "Urgent: Device Recall" letter to Consignees beginning September 24, 2009 . Customers were instructed to inventory their stock and for all remaining product immediately discontinue use and return. Consignees were also instructed to contact their customers and notify them of the recall. For further information, contact Olsen Medical at 1-502-772-4272.

    Distribution

    Nationwide Distribution -- AZ, FL, IA, MD, MO, NM, OR, NV, TN, TX and VA.

    Quantity

    3,617 pieces