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Vero Biotech, LLC recalls GENOSYL DS (Delivery System) console, for use as a vasodilator.
Recalled October 6, 2021 · FDA recall Z-2587-2021 · Vero Biotech
Hazard
Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO). · FDA Class I
Units
120 consoles (3 consoles affected)
Sold at
Distributed within US to Texas and Illinois.
Description
Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
Product
GENOSYL DS (Delivery System) console, for use as a vasodilator.
Manufacturer(s)
Vero Biotech, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →