BEUDAMED
    FDA Enforcement Class II Ongoing

    BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.

    Recall: Z-1765-2022 · Reported September 28, 2022

    Enforcement

    Recall Number
    Z-1765-2022
    Event ID
    90740
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Maquet Medical Systems USA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 28, 2022
    Initiation Date
    July 22, 2022
    Classification Date
    September 19, 2022
    Address
    45 Barbour Pond Dr, N/A, Wayne, NJ, 07470-2094, United States

    Description

    BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.

    Reason

    The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).

    Code Info

    UDI-DI: 04037691773513 Lot 3000183908

    Distribution

    Worldwide distribution - US Nationwide and the countries Canada and Australia.

    Quantity

    206 US; 48,960 Worldwide