BEUDAMED
    FDA Enforcement Class II Ongoing

    QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330

    Recall: Z-1658-2023 · Reported June 7, 2023

    Enforcement

    Recall Number
    Z-1658-2023
    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-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330

    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-DI BEQ-HMOD30000-USA 701070397 4058863154435 BEQ-HMOD30000-USA 701050330 4037691670164 All lots

    Distribution

    Nationwide domestic distribution

    Quantity

    5,022 (US)