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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
Recalled April 18, 2018 · FDA recall Z-1365-2018 · Fresenius Medical Care Renal Therapies Group
Hazard
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. · FDA Class II
Units
9293
Sold at
Nationwide distribution.
Description
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.
Product
Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis.
Manufacturer(s)
Fresenius Medical Care Renal Therapies Group, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →