FDA recall Z-2587-2021

Product

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

Reason for recall

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

Distribution

Distributed within US to Texas and Illinois.

Key facts

Status

Completed

Initiation date

2021-09-09

Report date

2021-10-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Atlanta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2587-2021