Drug recall
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
FDA recall event 90011 · Class II · Caire, Inc.
Key facts
| Event ID | 90011 |
|---|---|
| Recall numbers | Z-1117-2022 |
| Recalling firm | Caire, Inc. |
| Product type | Devices |
| Products | CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The device was not cleared for U.S. distribution. |
| Initiation date | Mar 25, 2022 |
| Report date | May 25, 2022 |
| Termination date | Oct 5, 2023 |
| City | Ball Ground |
| State | GA |
| Country | United States |
| FEI number | 3004972304 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: