BEUDAMED
    FDA Recall Terminated

    OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 8900 0224 01 (single electrode, UDI: 00847946016272) Product Usage: Intended Use: Defibrillation, Cardioversion, Noninvasive Pacing, EGG Monitoring, CPR Sensor. For use with ZOLL Defibrillators: R Series, M Series. By Trained Personnel only, Including: Physicians, Nurses, Paramedics, Emergency Medical Technicians, Cardiovascular Laboratory Technicians.

    Recall: Z-0977-2018 · Initiated August 4, 2017

    Recall

    Recall Number
    Z-0977-2018
    Event Number
    79204
    FEI Number
    1220908
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 4, 2017
    Terminated
    August 31, 2018
    Address
    ZOLL Medical Corporation 269, &, Chelmsford, MA, 01824

    Description

    OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 8900 0224 01 (single electrode, UDI: 00847946016272) Product Usage: Intended Use: Defibrillation, Cardioversion, Noninvasive Pacing, EGG Monitoring, CPR Sensor. For use with ZOLL Defibrillators: R Series, M Series. By Trained Personnel only, Including: Physicians, Nurses, Paramedics, Emergency Medical Technicians, Cardiovascular Laboratory Technicians.

    Reason

    A portion of one lot of ZOLL OneStep Complete Electrodes for adults will cause the defibrillator to deliver pediatric energy levels instead of adult energy levels when used with the ZOLL R Series Defibrillator. Defective electrodes will display PEDIATRIC PADS IN USE on the R Series defibrillator. Using the affected product with the M Series Defibrillator poses no risk.

    Action

    Zoll sent an Urgent Device Correction letter dated August 4, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. The following actions should be taken until the affected electrodes are removed from use: 1. Alert staff to the possibility of this occurrence. 2. Instruct staff to inspect the lot code on the electrode package and remove affected lot 2517A from use. 3. Inform users that if they encounter this situation in the process of defibrillating an adult patient, they should set the defibrillator energy level manually. 4. Complete the attached form and return to ZOLL for replacement electrodes. ZOLL will be replacing the effected lot of the electrodes with properly configured electrodes. For questions contact technical support at 1-800-348-9011 or 1-978-421-9460.

    Distribution

    Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and in the countries of Canada.

    Quantity

    3400