BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000

    Recall: Z-2206-2023 · Reported July 26, 2023

    Enforcement

    Recall Number
    Z-2206-2023
    Event ID
    92412
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 26, 2023
    Initiation Date
    May 12, 2023
    Classification Date
    July 20, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000

    Reason

    The scissors were manufactured without a tip protector resulting in the scissors breaking through the semi-rigid plastic tray compromising sterility.

    Code Info

    Lot numbers and UDI numbers: 23BBI031, 01100801968242291023BBI031; 23BBK353, 01100801968242291023BBK353; 23BBP830, 01100801968242291023BBP830; 23BBQ676, 01100801968242291023BBQ676; 23BBR546, 01100801968242291023BBR546; 23CBH009, 01100801968242291023CBH009; 23CBL930, 01100801968242291023CBL930; 23CBP165, 01100801968242291023CBP165; 23BBS369, 01100801968242291023BBS369; 23BBT718, 01100801968242291023BBT718; 23CBV064, 01100801968242291023CBV064; 23CBW834, 01100801968242291023CBW834; 23CBV222, 01100801968242291023CBV222; 23CBW020, 01100801968242291023CBW020; and 23CBQ190, 01100801968242291023CBQ190.

    Distribution

    US Nationwide distribution. There was government distribution but no military or foreign distribution.

    Quantity

    189,221 scissors