BEUDAMED
    FDA Recall 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 · Initiated July 2, 2018

    Recall

    Recall Number
    Z-2734-2018
    Event Number
    80474
    Firm
    Water Pik, Inc.
    FEI Number
    1712259
    Product Code
    JET
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 2, 2018
    Terminated
    May 24, 2022
    Address
    1730 East Prospect Road Fort, Collins, CO, 80553-0001

    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.

    Action

    On 07/02/2018, the firm sent customers an Urgent Medical Device Recall notice. Customers were instructed to stop using affected devices, immediately unplug the units, and to return these devices using firm-provided prepaid return labels. For questions, consumers should call 1-800-674-7718 from 7:00 a.m. to 5:00 p.m. MDT, Monday through Friday. On 07/05/2018, Urgent Medical Device Recall notices were mailed to all customers via overnight mail. On 07/13/2018, the firm issued a press release, which also stated to call 1-800-674-7718 to receive a product return kit. Customers were encouraged to report adverse events to MedWatch via http://www.fda.gov/MedWatch/report.htm (online), http://www.fda.gov/MedWatch/getforms.htm (mail), 1-800-332-1088 (phone), or 1-800-FDA-0178 (fax).

    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