BEUDAMED
    FDA Enforcement Class II Terminated

    Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.

    Recall: Z-2734-2018 · Reported August 15, 2018

    Enforcement

    Recall Number
    Z-2734-2018
    Event ID
    80474
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Water Pik, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 15, 2018
    Initiation Date
    July 2, 2018
    Classification Date
    August 8, 2018
    Termination Date
    May 24, 2022
    Address
    1730 East Prospect Road, N/A, Fort Collins, CO, 80553-0001, United States

    Description

    Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.

    Reason

    Charging base may overheat with localized melting and sparking, possibly causing fire, shock or burns.

    Code Info

    Serial #: SF02 17 06 01 through SF02 18 06 28

    Distribution

    U.S. Nationwide Distribution in the states of TX, KY, WA, NY, VA, CA, NC, IA, MA, OR, OH, GA, NV, CT, IL, SC, PA, MD, IN, WV, ND, MS, CO, AZ, WI, KS, FL, HI, OK, VT, MO, ID, RI, MN, MI, AR, LA, TN, DC, NJ, NH, NE, AL, UT, ME, NM, AK, DE, SD, MT, WY and country of Canada

    Quantity

    3797