Airway Gas Option N-CAiO

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Mfg. Lot or Serial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
  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:
GE Healthcare, LLC
Reason for Recall:
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Airway Gas Option N-CAiO

Product Codes/Lot Numbers:

Mfg. Lot or Serial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

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0760-2020

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