Device recall: Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and…

Class II FDA enforcement event 79625. Recall start date: 24 Jan 2018. Status in the FDA record: Terminated. Termination date: 11 May 2020.

Reason for recall, in the words of FDA

The recalling firm identified a software issue related to the Patient Line Check (PLC) which may result in an increased risk of Overfill (also known as Increased Intraperitoneal Volume, IIPV). Overfill/IIPV may result in serious injury or death.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Fresenius Medical Care Renal Therapies Group, LLC started this device recall on 24 Jan 2018. The firm address in the FDA record is in Waltham, MA. FDA put the recall in Class II. FDA event 79625 has 1 product record. The first FDA enforcement report date is 18 Apr 2018. The record gives the status Terminated, with the termination date 11 May 2020.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide distribution.

Recalling firm

Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 79625: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1365-2018	Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis.	9293	Class II	Terminated	18 Apr 2018

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2018: 1,074
Share of these events in Class II: 92%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 22

Other events of the firm

Other FDA enforcement events of Fresenius Medical Care Renal Therapies Group, LLC
Initiated	Product (first record)	Type	Class	Records
10 Aug 2026	5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6	Device	Class II	4
14 Jul 2026	GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysi	Device	Class II	3
30 Jun 2026	Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.	Device	Class II	1
29 May 2019	Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conj	Device	Class II	1
3 Apr 2019	2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis	Device	Class III	1
5 Nov 2018	Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E	Device	Class II	1
9 Oct 2018	Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis	Device	Class III	3
13 Jul 2018	2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Numb	Device	Class II	2
2 May 2018	NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This con	Device	Class II	1
20 Dec 2017	DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2	Drug	Class II	1

Fresenius Medical Care Renal Therapies Group, LLC: all 22 events

Official channels

FDA enforcement report Z-1365-2018The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 79625. https://recallregister.com/fda/ii/79625/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide distribution.
What quantity of product is in FDA event 79625?: The FDA record gives this quantity: 9293
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2018 have the same class?: 92% of the 1,074 device events that started in 2018 are in Class II.