Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2734-2018Class II

Waterpik Sonic-Fusion Professional, Model: SF-02

Water Pik, Inc. / initiated 2018-07-02 / Terminated

Water Pik, Inc. began a recall of 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... on . FDA classified it as Class II and gives the reason as "Charging base may overheat with localized melting and sparking, possibly causing fire, shock or burns". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-2734-2018
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Water Pik, Inc.
Product
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.
Product code
JET Pick, Massaging
Reason for recall
Charging base may overheat with localized melting and sparking, possibly causing fire, shock or burns.
FDA root cause
Under Investigation by firm
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).
Quantity in commerce
3797
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
Product codes and lots
Serial #: SF02 17 06 01 through SF02 18 06 28

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2734-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2734-2018Class IITerminatedVoluntary: Firm initiated