BEUDAMED
    FDA Enforcement Class II Ongoing

    Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY

    Recall: Z-0150-2025 · Reported October 30, 2024

    Enforcement

    Recall Number
    Z-0150-2025
    Event ID
    95415
    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
    October 30, 2024
    Initiation Date
    September 4, 2024
    Classification Date
    October 23, 2024
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY

    Reason

    It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

    Code Info

    a) UDI/DI 40653160270929 (each), 10653160270928 (case), Lot Numbers: 23LBO858; b) UDI/DI 40653160284346 (each), 10653160284345 (case), Lot Numbers: 23LBL653

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Panama.

    Quantity

    168 units