FDA recall Z-0805-2020

Product

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-11-21

Report date

2020-01-22

Termination date

2020-11-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ball Ground, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0805-2020