Recall Z-1365-2018— Fresenius Medical Care Renal Therapies Group, LLC
Class II · Terminated
Class II FDA medical device recall by Fresenius Medical Care Renal Therapies Group, LLC, initiated 2018-01-24, terminated 2020-05-11. It names one FDA 510(k) clearance: K171652. 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: 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..
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-01-24
- Terminated
- 2020-05-11
- Firm location
- Waltham, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.