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.
FDA Recall Z-0805-2020 · Posted None
Recalling FirmCaire, Inc.
Recall StatusTerminated
Product CodeCAW
Date Initiated2019-11-21
Date Terminated2020-11-20
Product Quantity4 units
Reason for Recall
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Firm Action
The firm initiated the recall by telephone and email on 11/19/2019, then followed with a letter on 12/04/2019. The firm requested the removal of all units and will exchange them for the US approved version.
Root Cause
Packaging process control
Distribution Pattern
US Nationwide distribution in the states of MI, CA, CT.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.