BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Leg bag, REF URO12573

    Recall: Z-0535-2024 · Reported December 20, 2023

    Enforcement

    Recall Number
    Z-0535-2024
    Event ID
    93306
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 20, 2023
    Initiation Date
    October 19, 2023
    Classification Date
    December 12, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Medline Leg bag, REF URO12573

    Reason

    Undeclared latex

    Code Info

    UDI/DI 20888277719290 (case), 10888277719293 (insert), Lot Numbers: 48623050001, 48623060001

    Distribution

    US and Panama

    Quantity

    144 devices