medical Class II Updated 2022-05-25

Caire, Inc. recalls CAIRE FreeStyle Comfort Portable Oxygen Concentrator with au

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Distribution was made to Puerto Rico. There was no foreign/government/military distribution.
Lot/Code Info: Serial numbers CBB5221200337 and CBB5221200287.
View official government recall

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