CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Summary
The FDA issued a Class II for CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense an by Caire, Inc.. Reason: The device was not cleared for U.S. distribution..
Details
Source
Device Recall
External ID
Z-1117-2022
Action Date
2022-05-25
Status
Terminated
Category
device
Product Description
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Lot/Code Info: Serial numbers CBB5221200337 and CBB5221200287.
Quantity Affected: 2 oxygen concentrators
Reason for Recall
The device was not cleared for U.S. distribution.
Distribution
Distribution was made to Puerto Rico. There was no foreign/government/military distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-25
Company
Ball Ground, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Caire, Inc. has 10 FDA actions in our database, including 9 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Caire, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Caire, Inc. have FDA actions?
Caire, Inc. has 10 FDA actions in our database, including 9 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1117-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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