BEUDAMED
    FDA Enforcement Class II Ongoing

    O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000

    Recall: Z-0755-2025 · Reported January 1, 2025

    Enforcement

    Recall Number
    Z-0755-2025
    Event ID
    95843
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2025
    Initiation Date
    November 12, 2024
    Classification Date
    December 23, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000

    Reason

    Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.

    Code Info

    UDI: 10193489191349 (ea) 20193489191346 (case); Lot 2023052490

    Distribution

    US Nationwide distribution.

    Quantity

    21,440 total