Inovo, Inc recalls Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow of oxygen from an oxygen tank…

Recall date

April 26, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2099-2019

FDA classification

Class II

Brand / firm

Inovo, Inc

Sold / distributed

US Nationwide Distribution - AZ, CO, FL, GA, IL, LA, MI, MO, MT, NY, SC, TX, and UT

Why it was recalled

The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak.

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

What was recalled

Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow of oxygen from an oxygen tank and only deliver oxygen as the patient inhales, resulting in greater efficiency and cost saving ratios.