CLASS II Device recall · Reported 3 Feb 2016 · FDA Enforcement Report

Fresenius Liberty Cycler-Peritoneal Dialysis Cycler recalled

Fresenius Medical Care Renal Therapies Group is recalling Fresenius Liberty Cycler-Peritoneal Dialysis Cycler, distributed nationwide in the US. The recall was initiated on 15 Dec 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lot numbers

Quantity recalled14,094 units

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-0693-2016
FDA event ID: 72926
Recalling firm: Fresenius Medical Care Renal Therapies Group, Waltham, MA
Classification: Class II
Status: Terminated
Recall initiated: 15 Dec 2015
FDA classified: 27 Jan 2016
Reported: 3 Feb 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

15 Dec 2015	Recall initiated by company
27 Jan 2016	Classified by FDA	+43 days
3 Feb 2016	Published in enforcement report	+7 days

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

Reason for recall

The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause injury, delay in treatment, or Increased Intraperitoneal Volume (IIPV) (overfill).

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

Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Is Fresenius Liberty Cycler-Peritoneal Dialysis Cycler recalled?

Yes. Fresenius Medical Care Renal Therapies Group recalled Fresenius Liberty Cycler-Peritoneal Dialysis Cycler on 15 Dec 2015. The recall is Class II and its status is Terminated. Recall number Z-0693-2016.

Why was it recalled?

Which lots are affected?

All lot numbers

Where was it sold?

Nationwide Distribution

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 21 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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