BEUDAMED
    FDA Recall Terminated

    SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.

    Recall: Z-1837-2021 · Initiated May 21, 2021

    Recall

    Recall Number
    Z-1837-2021
    Event Number
    87976
    Firm
    Sunstar Americas, Inc.
    FEI Number
    1413787
    Product Code
    NTO
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 21, 2021
    Terminated
    September 4, 2024
    Address
    301 E Central Rd, Schaumburg, IL, 60195-1901

    Description

    SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.

    Reason

    Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.

    Action

    The firm initiated the recall by letter on 05/21/2021. The firm is requesting the return of the product and has directed the distributors to notify their customers.

    Distribution

    Worldwide distribution - US Nationwide distribution and the country of Mexico.

    Quantity

    124064 units