FDA Device recall Z-1365-2018
Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dial…
- FDA Device
- Class II
- terminated
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class II recall of Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dial… by Fresenius Medical Care Renal Therapies Group, citing 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 V….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1365-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-24 |
| Published | 2018-04-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Fresenius Medical Care Renal Therapies Group |
| Distribution | US |
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.
Identifiers
| code_info | Serial Numbers: LC102494 LC013494 LC105025 LC018458 LC000876 LC008380 LC104548 LC017075 LC104397 LC014312 LC003306 LC01…Serial Numbers: LC102494 LC013494 LC105025 LC018458 LC000876 LC008380 LC104548 LC017075 LC104397 LC014312 LC003306 LC015722 LC103879 LC105345 LC013863 LC105105 LC001731 LC020284 LC006439 LC013691 LC007915 LC103329 LC007321 LC023968 LC024113 LC105830 LC022009 LC102520 LC103883 LC105542 LC100857 LC104463 LC002679 LC003112 LC008814 LC023106 LC015078 LC020375 LC001669 LC010040 LC018692 LC002033 LC025214 LC000552 LC002895 LC014198 LC007063 LC100901 LC007381 LC021887 LC018820 LC004947 LC018792 LC021016 LC104232 LC020799 LC104339 LC012661 LC105175 LC104496 LC014929 LC105231 LC102218 LC102781 LC008363 LC014206 LC025287 LC007753 LC026180 LC101027 LC102512 LC105188 LC015687 LC023458 LC105896 LC103342 LC102526 LC104896 LC104628 LC103549 LC018183 LC009100 LC020103 LC104518 LC101890 LC006687 LC000843 LC013499 LC019400 LC105235 LC007159 LC025366 LC010069 LC004120 LC100082 LC102647 LC020593 LC024058 LC001762 LC020907 LC008540 LC103600 LC000479 LC020698 LC023463 LC022836 LC010744 LC021206 LC0233 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1365-2018%22
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