BEUDAMED
    FDA Enforcement Class II Terminated

    Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

    Recall: Z-0498-2013 · Reported December 19, 2012

    Enforcement

    Recall Number
    Z-0498-2013
    Event ID
    61209
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LLC dba Uni-Patch
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 19, 2012
    Initiation Date
    February 9, 2012
    Classification Date
    December 10, 2012
    Termination Date
    January 3, 2013
    Address
    1313 Grant Blvd W, N/A, Wabasha, MN, 55981-1058, United States

    Description

    Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

    Reason

    Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut.

    Code Info

    Lots 202028 and 202722

    Distribution

    Nationwide Distribution including CA, IL, MA, MN, and SD.

    Quantity

    2,014 pouches