Vero Biotech, LLC recalls GENOSYL DS (Delivery System) console, for use as a vasodilator.

Recall date

September 9, 2021

Source

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

Recall number

Z-2587-2021

FDA classification

Class I

Brand / firm

Vero Biotech, LLC

Sold / distributed

Distributed within US to Texas and Illinois.

Why it was recalled

Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).

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 (Delivery System) console, for use as a vasodilator.