2008 K2 Hemodialysis Machine with software version 5 — Class II medical device recall Z-1278-2018
Terminated recall by Fresenius Medical Care Renal Therapies Group, LLC, reported 2018-04-11, distributed in AR, CA, CO, FL, GA, IL, MA, MD…. When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the
| Recall number | Z-1278-2018 |
|---|---|
| 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 | 2017-12-14 |
| Classified | 2018-03-30 |
| Reported by FDA | 2018-04-11 |
| Terminated | 2021-09-22 |
| Distributed | AR, CA, CO, FL, GA, IL, MA, MD, MN, NC, NY, OH, PA, SC, TN, TX |
| Quantity | 127 |
| UPC / GTIN / UDI-DI | 00840861100859, 00840861100866 |
| Serial numbers | 00840861100859PLS, 0K0S151801, 190610, 1K0S169898, 1K0S169954, 1K0S170154, 1K0S170234, 1K0S171275, 1K0S171286, 1K0S171421, 1K0S171436, 2K0S176243, 2K0S176244, 2K0S176257, 2K0S176264, 2K0S176271, 2K0S176273, 2K0S176278, 2K0S176280, 2K0S176281, 2K0S176283, 2K0S176286, 2K0S176443, 2K0S176472, 2K0S176633 and 212 more |
Product
2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy.
Reason for recall
When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation UF rate which may be up to 4000ml/hour. The SLED program is required to limit the UF rate to a maximum of 1000 ml/hour.
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-1278-2018. 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.