FDA recall Z-1117-2022

Product

CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3

Reason for recall

The device was not cleared for U.S. distribution.

Distribution

Distribution was made to Puerto Rico. There was no foreign/government/military distribution.

Key facts

Status

Terminated

Initiation date

2022-03-25

Report date

2022-05-25

Termination date

2023-10-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ball Ground, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1117-2022