FDAFDA · Food and drugs·Recall number Z-1117-2022
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Published May 25, 2022 · Recall initiated: March 25, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The device was not cleared for U.S. distribution.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Caire, Inc.
- Distributor
- Distribution was made to Puerto Rico. There was no foreign/government/military distribution.
- Lot
- Serial numbers CBB5221200337 and CBB5221200287.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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