BEUDAMED
    FDA Enforcement Class II Terminated

    BUTLER Clear Dip, 12 bottles/case

    Recall: Z-0720-2022 · Reported March 9, 2022

    Enforcement

    Recall Number
    Z-0720-2022
    Event ID
    89460
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sunstar Americas, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 9, 2022
    Initiation Date
    January 14, 2022
    Classification Date
    March 3, 2022
    Termination Date
    August 28, 2023
    Address
    301 E Central Rd, Schaumburg, IL, 60195-1901, United States

    Description

    BUTLER Clear Dip, 12 bottles/case

    Reason

    Product lacks premarket clearance.

    Code Info

    SKU 716P (Clear Dip 16oz), Lots: 1) S350LP 2) S350LN 3) T116JA 4) T117JE 5) T187DH 6) T187DJ 7) T263FD

    Distribution

    United States Nationwide distribution.

    Quantity

    22514 ea