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Caire, Inc. Recall: CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, Ult

Caire, Inc. Recall: CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, Ult is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Caire, Inc.; Product: CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3; Reason for recall

Recalling firmCaire, Inc.
ProductCAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Reason for recallThe device was not cleared for U.S. distribution.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionDistribution was made to Puerto Rico. There was no foreign/government/military distribution.
Recall initiated20220325
Recall numberZ-1117-2022
Categorydevice
StateGA
CountryUnited States

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