Device product
CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit
Z-0336-2023
Product summary
- Firm
- Caire, Inc.
- Event
- Event 90999
- Status
- Terminated
- Classification
- Class I
- Quantity
- 10 devices
- Official record key
device-enforcement:Z-0336-2023
Official wording
Reason: 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.
Code information: UDI/DI M766132616990, Serial Numbers: CBB3022310887, CBB3022310888, CBB3022310852, CBB3022310823, CBB3022310792, CBB3022310843, CBB3022310844, CBB3022310827, CBB3022310842, CBB3022310845
Distribution pattern: US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany
Derived failure modes
-
Unknown
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.