BEUDAMED
    FDA Enforcement Class II Ongoing

    Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395

    Recall: Z-1766-2025 · Reported May 21, 2025

    Enforcement

    Recall Number
    Z-1766-2025
    Event ID
    96732
    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
    May 21, 2025
    Initiation Date
    April 9, 2025
    Classification Date
    May 15, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395

    Reason

    Three is the potential for the retractors to puncture through the sterile packaging.

    Code Info

    UDI/DI 10653160287018 (each) 00653160287011 (case), Lot Numbers: 2020061990, 2020070990, 2020110490, 2020111090, 2021082590, 2021121490, 2022062890, 2022110190, 2022121990, 2023032290, 2023032390, 2023092590, 2024050790, 2024053090, 2024062490, 2024070190.

    Distribution

    US Nationwide distribution.

    Quantity

    840 units