Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0439-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343

Product Classification:

Class II

Date Initiated: September 12, 2020

Date Posted: November 18, 2020

Recall Number: Z-0439-2021

Event ID: 86537

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.

Status: Completed

Product Quantity: 9,907 devices

Code Information:

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

Distribution Pattern:

Distributed nationwide throughout the U.S and Puerto Rico. 9,907 devices currently in the field. 361 devices have been deactivated. 4,870 devices are ready to be shipped to customers along with the Urgent Medical Device Correction notice and response form.

Voluntary or Mandated:

Voluntary: Firm initiated