Caire, Inc.: 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.

Agency Publication Date: December 2, 2022

Affected Products

Product: CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit

UDI/DI M766132616990, Serial Numbers: CBB3022310887, CBB3022310888, CBB3022310852, CBB3022310823, CBB3022310792, CBB3022310843, CBB3022310844, CBB3022310827, CBB3022310842, CBB3022310845

Product: CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit

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

Product: CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit

UDI/DI M766133374030, Serial Numbers: CBB3022300368, CBB3022300390, CBB3022300470, CBB3022300472, CBB3022300479

Product: CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit

UDI/DI M766133374030M766132561950, Serial Numbers: CBB3022320073, CBB3022320077, CBB3022320074

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90999

Status: Resolved

Manufacturer: Caire, Inc.

Manufactured In: United States

Units Affected: 4 products (10 devices; 70 devices; 5 devices; 3 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.