Inovo, Inc recalls PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S

Recall date

October 9, 2017

Source

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

Recall number

Z-0407-2018

FDA classification

Class II

Brand / firm

Inovo, Inc

Sold / distributed

worldwide

Why it was recalled

Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demonstrate an aggregate complaint/service rate greater than 35% for low oxygen purity (output oxygen below the published specification).

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

What was recalled

PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S