BEUDAMED
    FDA Enforcement Class II Terminated

    SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA

    Recall: Z-1382-2021 · Reported April 21, 2021

    Enforcement

    Recall Number
    Z-1382-2021
    Event ID
    87600
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sunstar Americas, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 21, 2021
    Initiation Date
    March 23, 2021
    Classification Date
    April 9, 2021
    Termination Date
    August 28, 2023
    Address
    301 E Central Rd, N/A, Schaumburg, IL, 60195-1901, United States

    Description

    SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA

    Reason

    Product may be contaminated with Burkholderia contaminans.

    Code Info

    Lot Numbers; 532952, 535180, 536513, 536514, 539487, 551038, 551039

    Distribution

    US and Taiwan, Thailand, Malaysia, Japan, Hong Kong, Mexico

    Quantity

    19471 bottles