BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline CHEST TUBE REORDER NO: DYNJ36762A

    Recall: Z-1683-2022 · Reported September 14, 2022

    Enforcement

    Recall Number
    Z-1683-2022
    Event ID
    90689
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 14, 2022
    Initiation Date
    July 21, 2022
    Classification Date
    September 7, 2022
    Address
    12001 General Milton, N/A, Laredo, TX, 78045, United States

    Description

    Medline CHEST TUBE REORDER NO: DYNJ36762A

    Reason

    Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit

    Code Info

    Model Number: DYNJ36762A UDI-DI Code (GTIN Insert/GTIN Case / Lot Number: (01)1019348989440/(01)40193489894401 / 21ILA164 (01)1019348989440/(01)40193489894401 / 21ILA986 (01)1019348989440/(01)40193489894401 / 21JLA315 (01)1019348989440/(01)40193489894401 / 21KLA005 (01)1019348989440/(01)40193489894401 / 21KLA162 (01)1019348989440/(01)40193489894401 / 21KLA629

    Distribution

    U.S. Nationwide distribution in the state of AL.

    Quantity

    300 kits