Caire, Inc. recalls CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intend…

Recall date

November 21, 2019

Source

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

Recall number

Z-0805-2020

FDA classification

Class II

Brand / firm

Caire, Inc.

Sold / distributed

US Nationwide distribution in the states of MI, CA, CT.

Why it was recalled

Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..

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

What was recalled

CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.