BEUDAMED
    FDA Enforcement Class II Ongoing

    namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit

    Recall: Z-1428-2025 · Reported April 2, 2025

    Enforcement

    Recall Number
    Z-1428-2025
    Event ID
    96367
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 2, 2025
    Initiation Date
    February 12, 2025
    Classification Date
    March 21, 2025
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit

    Reason

    The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

    Code Info

    UDI/DI 10193489067507 (each), 20193489067504 (case), Lot number 0000140528

    Distribution

    Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia

    Quantity

    4400 units