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U.S. Department of Health and Human Services

Class 2 Device Recall FreeStyle Comfort Oxygen Concentrator

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  Class 2 Device Recall FreeStyle Comfort Oxygen Concentrator see related information
Date Initiated by Firm November 21, 2019
Create Date January 13, 2020
Recall Status1 Open3, Classified
Recall Number Z-0805-2020
Recall Event ID 84512
Product Classification Generator, oxygen, portable - Product Code CAW
Product 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.
Code Information Serial Numbers: CBB5219310254, CBB5219310255, CBB5219310279, CBB5219310280
Recalling Firm/
Manufacturer
Caire, Inc.
2200 Airport Industrial Dr Ste 500
Ball Ground GA 30107-4686
For Additional Information Contact
770-721-7700
Manufacturer Reason
for Recall
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
FDA Determined
Cause 2
Packaging process control
Action The firm initiated the recall by telephone and email on 11/19/2019, then followed with a letter on 12/04/2019. The firm requested the removal of all units and will exchange them for the US approved version.
Quantity in Commerce 4 units
Distribution US Nationwide distribution in the states of MI, CA, CT.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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