BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049

    Recall: Z-2595-2023 · Reported September 27, 2023

    Enforcement

    Recall Number
    Z-2595-2023
    Event ID
    92881
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 27, 2023
    Initiation Date
    August 3, 2023
    Classification Date
    September 18, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049

    Reason

    4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could compromise the sterile barrier system by puncturing large and/or small holes that may not be visible to the user.

    Code Info

    UDI/DI 10080196847273, all lots

    Distribution

    Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Canada, Hong Kong, Taiwan, Singapore

    Quantity

    324,451 devices