BEUDAMED
    FDA Recall Terminated

    VIASYS Healthcare Disposable Bar Electrodes. Re-order No. 019-435600. Single Use only. Manufactured in the U.S.A. for VIASYS Healthcare, 5225 Verona Road, Bldg 2, Madison, WI USA 53711-4495..Each box contains 10 pouches of Bar Electrodes and each pouch contains 10 electrodes

    Recall: Z-1254-06 · Initiated April 28, 2006

    Recall

    Recall Number
    Z-1254-06
    Event Number
    35416
    Firm
    Nicolet Biomedical Div of Viasys Healthcare
    FEI Number
    3010611950
    Product Code
    GXZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 28, 2006
    Posted
    July 25, 2006
    Terminated
    December 27, 2006
    Address
    5225 Verona Rd, Madison, WI, 53711-4497

    Description

    VIASYS Healthcare Disposable Bar Electrodes. Re-order No. 019-435600. Single Use only. Manufactured in the U.S.A. for VIASYS Healthcare, 5225 Verona Road, Bldg 2, Madison, WI USA 53711-4495..Each box contains 10 pouches of Bar Electrodes and each pouch contains 10 electrodes

    Reason

    The Bar Electrodes do not meet performance specification for electrode impedance. A manufacturing defect was discovered in disposable bar electrodes, part number 019-435600, lot 604664, that has the potential to reduce the amplitude of a motor or sensory nerve action potential. These possible lower amplitudes will be measured only if the bar electrode is used as a bar.

    Action

    Communication on April 28, 2006 by phone, followed by Certified Mail, with return receipt to confirm receipt of information . The letter describes the issue and asks that affected product be returned. The customer notification allows the user the option of using the Bar Electrode as 2 separate electrodes, as described in the Instructions for Use.

    Distribution

    World wide including the states of AL, CA, CT, FL, IA, NH, NY, OH, TX. and countries of Canada, Japan, Poland

    Quantity

    53 boxes, 10 electrodes per pouch, 10 pouches per box