BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated November 17, 2023

    Recall

    Recall Number
    Z-0564-2024
    Event Number
    93475
    Firm
    Vero Biotech, LLC
    FEI Number
    3014617112
    Product Code
    MRN
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    November 17, 2023
    Posted
    December 15, 2023
    Address
    387 Technology Cir Nw, Ste 125, Atlanta, GA, 30313-2411

    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.

    Action

    VERO BIOTECH issued an URGENT: MEDICAL DEVICE REMOVAL notice to its consignees on 11/17/2023 via email, The notice explained the issue and advised the consignee of the removal of the device from their possession on 11/03/2023.

    Distribution

    US: AZ and FL

    Quantity

    2 cassettes