# FDA recall Z-1365-2018

> **Fresenius Medical Care Renal Therapies Group, LLC** · Class II · device recall initiated 2018-01-24.

## Product

Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343    Product Usage:  The device is indicated for acute and chronic peritoneal dialysis.

## Reason for recall

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.

## Distribution

Nationwide distribution.

## Key facts

- **Recall number:** Z-1365-2018
- **Recalling firm:** Fresenius Medical Care Renal Therapies Group, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-24
- **Report date:** 2018-04-18
- **Termination date:** 2020-05-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1365-2018

## Citation

> AI Analytics. FDA recall Z-1365-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1365-2018. Source: US FDA. Licensed CC0.

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