BEUDAMED
    FDA Enforcement Class II Terminated

    BASIN SET, MEBS42K, general surgical kit

    Recall: Z-0274-2023 · Reported November 30, 2022

    Enforcement

    Recall Number
    Z-0274-2023
    Event ID
    91077
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    American Contract Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 30, 2022
    Initiation Date
    October 12, 2022
    Classification Date
    November 22, 2022
    Termination Date
    March 6, 2025
    Address
    2610 Ne Industrial Dr Ste 220, N/A, Kansas City, MO, 64117-2648, United States

    Description

    BASIN SET, MEBS42K, general surgical kit

    Reason

    Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of the package do not match the contents listed on the label.

    Code Info

    UDI/DI 00191072151742, Batch/Lot No. 833221, exp 6/16/2023

    Distribution

    US Nationwide distribution.

    Quantity

    1504 trays