Liberty Select Cycler — Class II medical device recall Z-1365-2018
Terminated recall by Fresenius Medical Care Renal Therapies Group, LLC, reported 2018-04-18, distributed nationwide. The recalling firm identified a software issue related to the Patient Line Check (PLC) which may result in an
| Recall number | Z-1365-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA, United States |
| Recall initiated | 2018-01-24 |
| Classified | 2018-04-11 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2020-05-11 |
| Distributed | Nationwide (US) |
| Quantity | 9,293 |
| Reason classes | software |
| Serial numbers | LC000020, LC000108, LC000112, LC000136, LC000149, LC000156, LC000163, LC000165, LC000166, LC000180, LC000190, LC000258, LC000259, LC000282, LC000292, LC000297, LC000312, LC000325, LC000326, LC000357, LC000359, LC000396, LC000410, LC000423, LC000470 and 475 more |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1365-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.