Vero Biotech, LLC FDA Recalls

3 recalls on file across devices, 2 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oClass IINov 17, 2023Cassette did not meet an 1n-process flow criterion.	Cassette did not meet an 1n-process flow criterion.	Class IIDevices	Nov 17, 2023
GENOSYL DS (Delivery System) console, for use as a vasodilator.Class ISep 9, 2021Manufacturing defect involving reversal of the inlet and out	Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen d	Class IDevices	Sep 9, 2021
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860Class IMay 19, 2021Reports received of NO measured below desired dose during tr	Reports received of NO measured below desired dose during transition between primary console and backup consol	Class IDevices	May 19, 2021