Medical device recalls Moderate risk

Vero Biotech, LLC recalls VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric…

Recall date
November 17, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0564-2024
FDA classification
Class II
Brand / firm
Vero Biotech, LLC
Sold / distributed
US: AZ and FL

Why it was recalled

Cassette did not meet an 1n-process flow criterion.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for inhalation at the point of use

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