BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pack Number 613034702

    Recall: Z-1453-2025 · Reported April 2, 2025

    Enforcement

    Recall Number
    Z-1453-2025
    Event ID
    96374
    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 11, 2025
    Classification Date
    March 25, 2025
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pack Number 613034702

    Reason

    Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

    Code Info

    1) Pack Number 613034700: UDI/DI 10850009724004 (each) 40850009724005 (case), Lot Number 613034700; 2) Pack Number 613034702: UDI/DI 10850009724066 (each) 40850009724067 (case), Lot Number 613034702

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    90 units