FDA recall Z-1863-2021

Product

GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2021-05-19

Report date

2021-06-30

Termination date

2023-10-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Atlanta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1863-2021