Fresenius Medical Care Renal Therapies Group, LLC recalls Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chr…

Recall date

January 24, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1365-2018

FDA classification

Class II

Brand / firm

Fresenius Medical Care Renal Therapies Group, LLC

Sold / distributed

Nationwide distribution.

Why it was recalled

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 means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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