BEUDAMED
    FDA Recall Open, Classified

    BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish

    Recall: Z-1697-2023 · Initiated May 23, 2023

    Recall

    Recall Number
    Z-1697-2023
    Event Number
    92401
    Firm
    Young Dental Manufacturing I, LLC
    FEI Number
    1941138
    Product Code
    LBH
    Status
    Open, Classified
    Root Cause
    Employee error
    Initiated
    May 23, 2023
    Posted
    June 8, 2023
    Address
    13705 Shoreline Ct E, Earth City, MO, 63045-1202

    Description

    BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish

    Reason

    The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.

    Action

    Young Dental notified the single customer via certified mail on 05/23/2023. The customer was instructed to discard or return the affected product and complete and return the response form.

    Distribution

    US distribution to Florida, Nevada, and Pennsylvania.

    Quantity

    344 boxes