Class 2 Device Recall FreeStyle Comfort Oxygen Concentrator

• Date Initiated by Firm: October 04, 2024
• Date Posted: November 15, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0479-2025
• Recall Event ID: 95576
• 510(K)Number: K020324
• Product Classification: Generator, oxygen, portable - Product Code CAW
• Product: CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
• Code Information: UDI-DI: M766AS2001010; Serial numbers: CBB5224380888, CBB5224380868, CBB5224380846, CBB5224380842, CBB5224380298, CBB5224380295, CBB5224380282, CBB5224380251, CBB5224380011, CBB5224380010, CBB5224370651, CBB5224370598, CBB5224370445, CBB5224370431, CBB5224370420, CBB5224370230, CBB5224370227, CBB5224370191, CBB5224370185, CBB5224370168, CBB5224370165, CBB5224370009, and CBB5224350790.
• Recalling Firm/ Manufacturer: Caire, Inc.; 2200 Airport Industrial Dr Ste 500; Ball Ground GA 30107-4686
• For Additional Information Contact: Sheril Ray; 770-7217719
• Manufacturer Reason for Recall: Potential failure of affected units to recharge the battery of the oxygen concentrators.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The recalling firm issued letters via email on and dated 10/4/2024 to their "sold-to" DME (durable medical equipment) distributors. The letter explained the reason for recall, identified the affected serial numbers and when they were shipped to the DME distributor, and requested the devices be returned to the recalling firm immediately. They are informed the devices will be replaced with new or repaired units. The DME distributor is to contact the CAIRE Customer Service via phone or email to arrange for return of the devices. A Response Form: Acknowledgement of Receipt was enclosed to indicate they have read and understand the recall instructions.
• Quantity in Commerce: 23 concentrators
• Distribution: Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
• 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.

• 510(K) Database: 510(K)s with Product Code = CAW