BEUDAMED
    FDA Enforcement Class II Ongoing

    Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028

    Recall: Z-1297-2022 · Reported July 6, 2022

    Enforcement

    Recall Number
    Z-1297-2022
    Event ID
    90295
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Atrium Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 6, 2022
    Initiation Date
    April 21, 2022
    Classification Date
    June 28, 2022
    Address
    40 Continental Blvd, Merrimack, NH, 03054-4332, United States

    Description

    Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028

    Reason

    Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expiration date of 16SEP2024 (2024-09-16) while the case and shipper labels both showed 21SEP2024 (2024-09-21), causing product being used for up to five (5) days past the true expiration date

    Code Info

    UDI-DI: 20650862150289 - case / 00650862150285- each Lot Number: ME231010

    Distribution

    AZ IL KS LA MI NY OH OK TX VA

    Quantity

    56 cases (560 units / 10 units per case)