FDA recall Z-1365-2018

Fresenius Medical Care Renal Therapies Group, LLC · Class II · device

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

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

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