BEUDAMED
    FDA Enforcement Class II Ongoing

    QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416

    Recall: Z-1660-2023 · Reported June 7, 2023

    Enforcement

    Recall Number
    Z-1660-2023
    Event ID
    92006
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Maquet Medical Systems USA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 7, 2023
    Initiation Date
    May 18, 2023
    Classification Date
    May 30, 2023
    Address
    45 Barbour Pond Dr, N/A, Wayne, NJ, 07470-2094, United States

    Description

    QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416

    Reason

    Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.

    Code Info

    Model Item No. UDI HMO 10000-USA 701070412 4058863154473 HMO 11000-USA 701070416 4058863154558 All lots

    Distribution

    Nationwide domestic distribution

    Quantity

    0 (US)