BEUDAMED
    FDA Enforcement Class II Ongoing

    Centurion Sterile Weitlaner Retractor, Reorder: 67315

    Recall: Z-1765-2025 · Reported May 21, 2025

    Enforcement

    Recall Number
    Z-1765-2025
    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, Reorder: 67315

    Reason

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

    Code Info

    UDI/DI 10653160379867 (each) 00653160379860 (case), Lot Numbers: 2020092801, 2020100601, 2021022601, 2021032301, 2021042301, 2021060101, 2021062101, 2021090790, 2022021190, 2022032390, 2022040690, 2022061690, 2022072690, 2022091490, 2023020990, 2023100590, 2023120790, 2024012990, 2024022290, 2024040590, 2024070290, 2024080190, 2024092790, 2025011490.

    Distribution

    US Nationwide distribution.

    Quantity

    2100 units