🔍 RecallPedia

ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004

Class I - Dangerous
🏥 Medical Devices Recalled: March 6, 2020 Radiometer Medical ApS Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 902-754R2692N002 and 902-754R2692N001
  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:
Radiometer Medical ApS
Reason for Recall:
Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004

Product Codes/Lot Numbers:

Serial Numbers: 902-754R2692N002 and 902-754R2692N001

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1836-2020

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