CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit

Class I - Dangerous
🏥 Medical Devices Recalled: October 10, 2022 Caire Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Caire, Inc.
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0337-2023

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