FDA-Device2024-11-27Class II
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
Caire, Inc.
Hazard
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Sold states
Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
Affected count
23 concentrators
Manufactured in
2200 Airport Industrial Dr Ste 500, N/A, Ball Ground, GA, United States
Products
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0479-2025Don't want to check this manually?
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