BEUDAMED
    FDA Enforcement Class I Ongoing

    Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690

    Recall: Z-0992-2025 · Reported February 5, 2025

    Enforcement

    Recall Number
    Z-0992-2025
    Event ID
    96093
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2025
    Initiation Date
    December 31, 2024
    Classification Date
    January 29, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690

    Reason

    The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.

    Code Info

    1) ART600 UDI-DI: 10653160312727 (each), 00653160312720 (case), Lot Number 2024110190; 2) ART690 UDI-DI: 10653160318019 (each), 00653160318012 (case), Lot Number 2024092490

    Distribution

    US Nationwide.

    Quantity

    58 kits