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FDAMay 19, 2021device

GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

vero biotechvero

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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