BEUDAMED
    FDA Enforcement Class II Terminated

    CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545

    Recall: Z-0106-2023 · Reported October 26, 2022

    Enforcement

    Recall Number
    Z-0106-2023
    Event ID
    90901
    Classification
    Class II
    Status
    Terminated
    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 26, 2022
    Initiation Date
    September 7, 2022
    Classification Date
    October 20, 2022
    Termination Date
    March 4, 2026
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545

    Reason

    One lot of chest tube insertion trays, containing a silk suture component that is restricted to 1 cycle of sterilization, was processed though 2 cycles.

    Code Info

    UDI/DI 20653160222979, Lot Code 2022050690

    Distribution

    US Nationwide distribution in the states of CA and TX.

    Quantity

    18 kits