BEUDAMED
    FDA Enforcement Class I Ongoing

    Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B

    Recall: Z-2592-2025 · Reported October 8, 2025

    Enforcement

    Recall Number
    Z-2592-2025
    Event ID
    97495
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 8, 2025
    Initiation Date
    August 8, 2025
    Classification Date
    September 26, 2025
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B

    Reason

    Convenience kits labeled as sterile have not gone through the sterilization process.

    Code Info

    1) DYNJ0382730O, UDI-DI: 10198459117992(each), 40198459117993(case), Lot Number: 25GBC583; 2) DYNJ61038B, UDI-DI: 10195327596316(each), 40195327596317(case), Lot Number: 25GBF720;

    Distribution

    US Distribution to States of: FL, MD, NJ, TN

    Quantity

    22 units