Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    All Liberty Select Cyclers with Software Version 2.9.0 Model Number 180343 and RTLR180343
  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:
Fresenius Medical Care Holdings, Inc.
Reason for Recall:
The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not recognize the extra fluid is present and it will not make it available for treatment. Not having enough solution to complete treatment may lead to inadequate dialysis which could result in the accumulation of toxins and fluid. Symptoms may include shortness of breath, increased weight gain, and increased blood pressure.
Classification:
Class I - Dangerous

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

Status:
completed

Product Information

Full Description:

Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343

Product Codes/Lot Numbers:

All Liberty Select Cyclers with Software Version 2.9.0 Model Number 180343 and RTLR180343

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0439-2021

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