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.
Reported: January 22, 2020 Initiated: November 21, 2019 #Z-0805-2020
Product Description
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..
Details
- Recalling Firm
- Caire, Inc.
- Units Affected
- 4 units
- Distribution
- US Nationwide distribution in the states of MI, CA, CT.
- Location
- Ball Ground, GA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Caire, Inc.. Units affected: 4 units.
Why was this product recalled? ▼
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2020. Severity: Moderate. Recall number: Z-0805-2020.
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