BEUDAMED
    FDA Enforcement Class II Terminated

    Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.

    Recall: Z-1185-2013 · Reported May 8, 2013

    Enforcement

    Recall Number
    Z-1185-2013
    Event ID
    64868
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 8, 2013
    Initiation Date
    April 8, 2013
    Classification Date
    April 29, 2013
    Termination Date
    November 19, 2015
    Address
    15 Hampshire Street, Mansfield, MA, 02048-1113, United States

    Description

    Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.

    Reason

    Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient

    Code Info

    Lot Numbers: 228651, 232146, 235646X, 301833X, 303928X

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa.

    Quantity

    7485 (sets of 2)