BEUDAMED
    FDA Enforcement Class I Completed

    GENOSYL DS (Delivery System) console, for use as a vasodilator.

    Recall: Z-2587-2021 · Reported October 6, 2021

    Enforcement

    Recall Number
    Z-2587-2021
    Event ID
    88558
    Classification
    Class I
    Status
    Completed
    Product Type
    Devices
    Firm
    Vero Biotech, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 6, 2021
    Initiation Date
    September 9, 2021
    Classification Date
    September 30, 2021
    Address
    387 Technology Cir Nw Ste 125, N/A, Atlanta, GA, 30313-2411, United States

    Description

    GENOSYL DS (Delivery System) console, for use as a vasodilator.

    Reason

    Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).

    Code Info

    Model Number: 601588-01, Serial Numbers G0294 (UDI (01)00850000962026(11)200728(21)G0294); G0378 (UDI (01)00850000962026(11)200917(21)G0378); and MA000065 (UDI (01)00850000962026(11)210511(21)MA000065)

    Distribution

    Distributed within US to Texas and Illinois.

    Quantity

    120 consoles (3 consoles affected)