Z-0439-2021Class II

Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343

Name: Z-0439-2021 Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2020-09-12
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2020-09-12 / Completed / root cause: design

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343 on 2020-09-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-0439-2021
Classification: Class II
Status: Completed
Initiated: 2020-09-12
Posted: 2020-11-07
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Product code: FKX System, Peritoneal, Automatic Delivery
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.
Root cause tag: design
FDA root cause: Device Design
Action: On September 16, 2020, Urgent Medical Device Correction notices and response forms were issued to home therapy nurse managers and patients. Patients using a Liberty Select cycler with software version 2.9.0 are instructed to disable the Flow Alert option. Patients will no longer receive on an-screen Flow Alert message or an audible Flow Alert series of beeps. Instructions for disabling the Flow Alert alarm are included in the notification letter. Patients should continue to use their Liberty Select Cycler for treatment with the Flow Alert option set to "No". Fresenius Medical Care LLC is not requesting the return of the Liberty Select cyclers software version 2.9.0. Replacing the Liberty Select cycler will not resolve this issue. Please complete and return the enclosed Reply Form, indicating receipt and understanding of the communication and actions to take. For additional information, please call 1-855-616-2309 Monday - Friday 8:30 am-5 pm, EST or submit an online request any time at www.fmcna-medinfo.com.
Quantity in commerce: 9,907 devices
Distribution: 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.
Product codes and lots: All Liberty Select Cyclers with Software Version 2.9.0 Model Number 180343 and RTLR180343

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0439-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0439-2021	Class II	Completed	Voluntary: Firm initiated	2020-11-18	2020-11-07

Product code FKX

K171652Class IIFresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC / cleared 2017-09-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)