Vero Biotech, LLC recalls GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860

Recall date

May 19, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1863-2021

FDA classification

Class I

Brand / firm

Vero Biotech, LLC

Sold / distributed

Distributed nationwide to TX, MD, VA, GA, FL, KS, LA, MN, and NC

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860