| 2024-10-04 |
Class II
|
Completed |
Z-0481-2025 |
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2. |
— |
Potential failure of affected units to recharge the battery of the oxygen concentrators. |
| 2024-10-04 |
Class II
|
Completed |
Z-0480-2025 |
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103. |
— |
Potential failure of affected units to recharge the battery of the oxygen concentrators. |
| 2024-10-04 |
Class II
|
Completed |
Z-0479-2025 |
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101. |
— |
Potential failure of affected units to recharge the battery of the oxygen concentrators. |
| 2024-10-04 |
Class II
|
Completed |
Z-0478-2025 |
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1. |
— |
Potential failure of affected units to recharge the battery of the oxygen concentrators. |
| 2022-10-10 |
Class I
|
Terminated |
Z-0339-2023 |
CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit |
— |
An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units. |
| 2022-10-10 |
Class I
|
Terminated |
Z-0338-2023 |
CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit |
— |
An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units. |
| 2022-10-10 |
Class I
|
Terminated |
Z-0337-2023 |
CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit |
— |
An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units. |
| 2022-10-10 |
Class I
|
Terminated |
Z-0336-2023 |
CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit |
— |
An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units. |
| 2022-03-25 |
Class II
|
Terminated |
Z-1117-2022 |
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3 |
— |
The device was not cleared for U.S. distribution. |