BEUDAMED
    FDA Recall Open, Classified

    fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once

    Recall: Z-1103-2020 · Initiated January 27, 2020

    Recall

    Recall Number
    Z-1103-2020
    Event Number
    84707
    Firm
    Fridababy LLC
    FEI Number
    3005630901
    Product Code
    EFW
    Status
    Open, Classified
    Root Cause
    Use error
    Initiated
    January 27, 2020
    Posted
    January 30, 2020
    Address
    82 Ne 26th St, Ste 101, Miami, FL, 33137-4406

    Description

    fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once

    Reason

    FridaBaby has been made aware through customer reports that the product is being used outside of the labeled directions. Specifically, repeated chewing or biting on the SmileFrida, the ToothHugger has caused deterioration in the outer layer of the brush and in very rare occasions, may cause the hard plastic brush head to break, exposing a small metal piece welded inside the brush head.

    Action

    Consignees will be notified via email with recall letter. The letter identifies affected product, stated reason for recall, and request to inspect the product for evidence of misuse and discard if necessary. If product has not been used, the consignee is reminded to follow the product labeling. A response to the recall notification via email is requested.

    Distribution

    Nationwide. International distribution to Canada, Mexico, Nicaragua, Dominican Republic, Honduras, Chile, Peru, Qatar. No US governmental consignees.

    Quantity

    480,144