BEUDAMED
    FDA Enforcement Class II Ongoing

    VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for inhalation at the point of use

    Recall: Z-0564-2024 · Reported December 27, 2023

    Enforcement

    Recall Number
    Z-0564-2024
    Event ID
    93475
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Vero Biotech, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 27, 2023
    Initiation Date
    November 17, 2023
    Classification Date
    December 15, 2023
    Address
    387 Technology Cir Nw Ste 125, N/A, Atlanta, GA, 30313-2411, United States

    Description

    VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for inhalation at the point of use

    Reason

    Cassette did not meet an 1n-process flow criterion.

    Code Info

    Lot Code: W-0001-2023, Cassette serial numbers: GA01T707, GA01T108

    Distribution

    US: AZ and FL

    Quantity

    2 cassettes