FDA-Device2021-10-06Class I
GENOSYL DS (Delivery System) console, for use as a vasodilator.
Vero Biotech, LLC
Hazard
Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
Sold states
Distributed within US to Texas and Illinois.
Affected count
120 consoles (3 consoles affected)
Manufactured in
387 Technology Cir Nw Ste 125, N/A, Atlanta, GA, United States
Products
GENOSYL DS (Delivery System) console, for use as a vasodilator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2587-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief