Safety Alerts
Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical Device Safety Alert: CAIRE Inc. CAIRE FreeStyle Comfort portable oxygen concentrators
18 Nov 2024
The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning CAIRE Inc. CAIRE FreeStyle Comfort portable oxygen concentrators [Model #AS200-1, AS200-101, AS200-103 and AS200-2] [HKMD No.: 200227].
According to the FDA, there is a potential failure of affected units to recharge the battery of the oxygen concentrators.
For further information, please visit: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=95576
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 Nov 2024