Class 2 Device Recall FreeStyle Comfort Oxygen Concentrator

• Date Initiated by Firm: November 21, 2019
• Create Date: January 13, 2020
• Recall Status: Terminated on November 20, 2020
• 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: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.