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SFDA Warns against Using Waterpik "Sonic-Fusion" Flossing Toothbrush

Saudi Food and Drug Authority (SFDA) has warned against using waterpik "Sonic-Fusion" flossing toothbrush (Sonic-Fusion® Flossing Toothbrush) for two models and certain batch numbers duo to defect in the charging base which may lead to overheat with melting. This can cause fire, shock or burn to the user.

The following models have been recalled: Model No. SF-01 and Batch No. SF01 17 06 01 to SF01 18 06 28 as well as Model No. SF-02 and Batch No. SF02 17 06 01 to SF02 18 06 28.
The mentioned product made in U.S. and distributed between June 2017 and June 2018.

SFDA has notified health care providers that the product did not obtain a marketing authorization nor released through ports of entry. However, the user may got it by other means.

The authority has advised the users to make sure if the product is included to this call by looking to the batch number (in the bottom of the product). Consumers who have the affected products should stop using them. SFDA advise consumer to buy medical devices and products from distributors licensed by Saudi Food and Drug Authority and having sufficient warranties.

SFDA has encouraged the consumers to report any adverse events or problems suspected to be relevant to the product or any other medical devices to SFDA call center 19999, or or  .




 

Medical Equipment
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