Recall Z-1863-2021— Vero Biotech, LLC

Name: FDA recall Z-1863-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-19

Class I · Terminated

Class I FDA medical device recall by Vero Biotech, LLC, initiated 2021-05-19, terminated 2023-10-12. FDA's recall record names no specific 510(k) clearance for this event. Product: GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860. 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..

Recalling firm: Vero Biotech, LLC
Classification: Class I
Status: Terminated
Initiated: 2021-05-19
Terminated: 2023-10-12
Firm location: Atlanta, GA, United States

Product description

GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.