CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Reported: May 25, 2022 Initiated: March 25, 2022 #Z-1117-2022
Product Description
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.
Details
- Recalling Firm
- Caire, Inc.
- Units Affected
- 2 oxygen concentrators
- Distribution
- Distribution was made to Puerto Rico. There was no foreign/government/military distribution.
- Location
- Ball Ground, GA
Frequently Asked Questions
What product was recalled? ▼
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3. Recalled by Caire, Inc.. Units affected: 2 oxygen concentrators.
Why was this product recalled? ▼
The device was not cleared for U.S. distribution.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 25, 2022. Severity: Moderate. Recall number: Z-1117-2022.
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