Atlanta, GA, United States
Vero Biotech, LLC recalls
3 recalls recorded since 2018, most recently on 17 November 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)2
Ongoing Class II Medical devices
- Recall started
- 17 November 2023
- Reason
- Cassette did not meet an 1n-process flow criterion.
- Distribution
- US: AZ and FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0564-2024
- 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
Completed Class I Medical devices
- Recall started
- 9 September 2021
- Reason
- Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
- Distribution
- Distributed within US to Texas and Illinois.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2587-2021
- GENOSYL DS (Delivery System) console, for use as a vasodilator.
Terminated Class I Medical devices
- Recall started
- 19 May 2021
- Terminated
- 12 October 2023
- Reason
- 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.
- Distribution
- Distributed nationwide to TX, MD, VA, GA, FL, KS, LA, MN, and NC
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1863-2021
- GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.