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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2734-2018 | Class II | Terminated | Voluntary: Firm initiated |
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