Reported Apr 18, 2018 · Terminated
Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and…
Fresenius Medical Care Renal Therapies Group, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Medical Care Renal Therapies Group, LLC · 920 Winter St · Waltham, MA · 02451-1521
Is this the product you have?
- Liberty Select Cycler (SW v.2.8.7), Material
- Number RTLR108343 Product UsageThe device is indicated for acute and chronic peritoneal dialysis
- Lot codes and dates
- Serial Numbers
3,596 of 3,596 codes
LC102494LC013494LC105025LC018458LC000876LC008380LC104548LC017075LC104397LC014312LC003306LC015722LC103879LC105345LC013863LC105105LC001731LC020284LC006439LC013691LC007915LC103329LC007321LC023968LC024113LC105830LC022009LC102520LC103883LC105542LC100857LC104463LC002679LC003112LC008814LC023106LC015078LC020375LC001669LC010040LC018692LC002033LC025214LC000552LC002895LC014198LC007063LC100901LC007381LC021887LC018820LC004947LC018792LC021016LC104232LC020799LC104339LC012661LC105175LC104496
- Serial Numbers
- Amount recalled
- 9293
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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