Caire, Inc. Recall 90011
Description: CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Caire, Inc. Recall 90011 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1117-2022 |
| Event ID | 90011 |
| Event Description | CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3 |
| Product Type | Devices |
| Distribution | Distribution was made to Puerto Rico. There was no foreign/government/military distribution. |
| Quantity | 2 oxygen concentrators |
| Recall Reason | The device was not cleared for U.S. distribution. |
| Device Classification | 20220525 |
| Device Code Info | Serial numbers CBB5221200337 and CBB5221200287. |
| Center Classification Date | 20220519 |
| Recall Initiation Date | 20220325 |
| Recalling Firm | Caire, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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