BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756

    Recall: Z-0124-2023 · Reported November 2, 2022

    Enforcement

    Recall Number
    Z-0124-2023
    Event ID
    90911
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    November 2, 2022
    Initiation Date
    September 9, 2022
    Classification Date
    October 21, 2022
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756

    Reason

    Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.

    Code Info

    UDI/DI: (01)40888277983824 (case), (01)10888277983823 (kit), Lot Numbers: 22EMI516, 22DMG491

    Distribution

    US Nationwide distribution in the state of California.

    Quantity

    460 kits