BEUDAMED
    FDA Recall Completed

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

    Recall: Z-2587-2021 · Initiated September 9, 2021

    Recall

    Recall Number
    Z-2587-2021
    Event Number
    88558
    Firm
    Vero Biotech, LLC
    FEI Number
    3014617112
    Product Code
    MRN
    Status
    Completed
    Root Cause
    Process control
    Initiated
    September 9, 2021
    Address
    387 Technology Cir Nw, Ste 125, Atlanta, GA, 30313-2411

    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).

    Action

    On 09/09/2021, Vero Biotech notified customers via certified mail with letter titled, "URGENT: MEDICAL DEVICE RECALL GENOSYL DS LIMITED MANUFACTURING DEFECT." The letter notified the customer of the issue and there were no actions to be taken as the three affected devices were removed from the field prior and replaced.

    Distribution

    Distributed within US to Texas and Illinois.

    Quantity

    120 consoles (3 consoles affected)