CLASS II Device recall · Reported 18 Nov 2020 · FDA Enforcement Report

Liberty Select Cycler recalled by Fresenius Medical Care

Fresenius Medical Care Holdings is recalling Liberty Select Cycler, distributed nationwide in the US. The recall was initiated on 12 Sep 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Liberty Select Cyclers with Software Version 2.9.0 Model Number 180343 and RTLR180343

Quantity recalled9,907 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0439-2021
FDA event ID: 86537
Recalling firm: Fresenius Medical Care Holdings, Waltham, MA
Classification: Class II
Status: Completed
Recall initiated: 12 Sep 2020
FDA classified: 7 Nov 2020
Reported: 18 Nov 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

12 Sep 2020	Recall initiated by company
7 Nov 2020	Classified by FDA	+56 days
18 Nov 2020	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343

Where it was distributed

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.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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