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Recall Observatory FDA recall evidence

Device product

CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit

Z-0337-2023

October 10, 2022

Class I

Product summary

Firm
Caire, Inc.
Event
Event 90999
Status
Terminated
Classification
Class I
Quantity
70 devices
Official record key
device-enforcement:Z-0337-2023

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 M766132622530, Serial Numbers: CBB3022311044, CBB3022311042, CBB3022311043, CBB3022311040, CBB3022311242, CBB3022311098, CBB3022311093, CBB3022311094, CBB3022311077, CBB3022311053, CBB3022311049, CBB3022311065, CBB3022311051, CBB3022311075, CBB3022311078, CBB3022311097, CBB3022311096, CBB3022311079, CBB3022311045, CBB3022311046, CBB3022311236, CBB3022311230, CBB3022311217, CBB3022311231, CBB3022311164, CBB3022311225, CBB3022311226, CBB3022311133, CBB3022311192, CBB3022311163, CBB3022311216, CBB3022311228, CBB3022311227, CBB3022311162, CBB3022311198, CBB3022311211, CBB3022311202, CBB3022311155, CBB3022311135, CBB3022311171, CBB3022311121, CBB3022311106, CBB3022311109, CBB3022311108, CBB3022311084, CBB3022311083, CBB3022311092, CBB3022311081, CBB3022311082, CBB3022311141, CBB3022311131, CBB3022311136, CBB3022311183, CBB3022311178, CBB3022311130, CBB3022311179, CBB3022311139, CBB3022311177, CBB3022311105, CBB3022311146, CBB3022311172, CBB3022311140, CBB3022311125, CBB3022311169, CBB3022311068, CBB3022311176, CBB3022311170, CBB3022311180, CBB3022311057, CBB3022311129

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.