BEUDAMED
    FDA Enforcement Class II Ongoing

    Remington MEDICAL Drainage Bag, REF 600-D;

    Recall: Z-0487-2024 · Reported December 13, 2023

    Enforcement

    Recall Number
    Z-0487-2024
    Event ID
    93377
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Remington Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 13, 2023
    Initiation Date
    November 3, 2023
    Classification Date
    December 5, 2023
    Address
    6830 Meadowridge Ct, Alpharetta, GA, 30005-2202, United States

    Description

    Remington MEDICAL Drainage Bag, REF 600-D;

    Reason

    There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.

    Code Info

    UDI/DI 20813079020008, Lot Number 2325111

    Distribution

    US: PA and FL

    Quantity

    3080 devices