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Recall Observatory FDA recall evidence

Device product

CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit

Z-0338-2023

October 10, 2022

Class I

Product summary

Firm
Caire, Inc.
Event
Event 90999
Status
Terminated
Classification
Class I
Quantity
5 devices
Official record key
device-enforcement:Z-0338-2023

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 M766133374030, Serial Numbers: CBB3022300368, CBB3022300390, CBB3022300470, CBB3022300472, CBB3022300479

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.