BEUDAMED
    FDA Enforcement Class II 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 · Reported June 16, 2021

    Enforcement

    Recall Number
    Z-1837-2021
    Event ID
    87976
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sunstar Americas, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 16, 2021
    Initiation Date
    May 21, 2021
    Classification Date
    June 9, 2021
    Termination Date
    September 4, 2024
    Address
    301 E Central Rd, N/A, Schaumburg, IL, 60195-1901, United States

    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.

    Code Info

    SKU number 1775P, Lot Numbers: 01U, 02U, 03U, 01Z, 02Z, 03Z, 04Z, 05Z, 01A, 02A, 01B, 02B , 3B SKU number 1775R, Lot Numbers: 01U, 02U, 03U, 01Z, 02Z, 03Z, 04Z, 05Z, 01A, 02A, 01B, 02B , 3B

    Distribution

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

    Quantity

    124064 units