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Vero Biotech, LLC recalls GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
Recalled June 30, 2021 · FDA recall Z-1863-2021 · Vero Biotech
Hazard
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. · FDA Class I
Units
465 units
Sold at
Distributed nationwide to TX, MD, VA, GA, FL, KS, LA, MN, and NC
Description
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.
Product
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
Manufacturer(s)
Vero Biotech, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →