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U.S. Department of Health and Human Services

Class 2 Device Recall FreeStyle Comfort

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  Class 2 Device Recall FreeStyle Comfort see related information
Date Initiated by Firm March 25, 2022
Create Date May 19, 2022
Recall Status1 Terminated 3 on October 05, 2023
Recall Number Z-1117-2022
Recall Event ID 90011
510(K)Number K214032-not  
Product Classification Generator, oxygen, portable - Product Code CAW
Product CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Code Information Serial numbers CBB5221200337 and CBB5221200287.
Recalling Firm/
Manufacturer		 Caire, Inc.
2200 Airport Industrial Dr Ste 500
Ball Ground GA 30107-4686
For Additional Information Contact Sheril Ray
770-721-7719
Manufacturer Reason
for Recall		 The device was not cleared for U.S. distribution.
FDA Determined
Cause 2		 No Marketing Application
Action The recalling firm initially contacted the customer via voicemail and email on 3/25/2022. The email informed the consignee that the two affected units that were shipped to them could not be sold in the U.S. or its territories due to FDA approval. The email requested the consignee confirm their address so that call tags could be sent to them for return of the affected units. The consignee was informed the units will be replaced with the new AS200-1 units as soon as the recalled units are returned. The model and serial numbers were provided of the affected units. The voicemail message summarized the information that was in the email.
Quantity in Commerce 2 oxygen concentrators
Distribution Distribution was made to Puerto Rico. There was no foreign/government/military distribution.
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.
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