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-1640-2023 · Reported June 7, 2023

    Enforcement

    Recall Number
    Z-1640-2023
    Event ID
    92003
    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 26, 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

    1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

    Code Info

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

    Distribution

    Domestic distribution nationwide.

    Quantity

    0 (US)