Vero Biotech Recalls
3 recalls on record · June 30, 2021 to December 27, 2023 · Medical Devices
Recalls by year
21
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 27, 2023Medical DevicesFDA
Vero Biotech, LLC recalls VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric o
Hazard: Cassette did not meet an 1n-process flow criterion.
October 6, 2021Medical DevicesFDA
Vero Biotech, LLC recalls GENOSYL DS (Delivery System) console, for use as a vasodilator.
Hazard: Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
June 30, 2021Medical DevicesFDA
Vero Biotech, LLC recalls GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
Hazard: Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.