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Recall Observatory FDA recall evidence

Device product

CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit

Z-0336-2023

October 10, 2022

Class I

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

    reason.no_named_rule · v1.0.0

    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.