Product Safety Recalls

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Caire, Inc. Recall 90011

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

Caire, Inc. Recall 90011 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1117-2022
Event ID90011
Event DescriptionCAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Product TypeDevices
DistributionDistribution was made to Puerto Rico. There was no foreign/government/military distribution.
Quantity2 oxygen concentrators
Recall ReasonThe device was not cleared for U.S. distribution.
Device Classification20220525
Device Code InfoSerial numbers CBB5221200337 and CBB5221200287.
Center Classification Date20220519
Recall Initiation Date20220325
Recalling FirmCaire, Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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