Fresenius 2008K@home Series : Hemodialysis System — Class II medical device recall Z-1029-2017
Terminated recall by Fresenius Medical Care Renal Therapies Group, LLC, reported 2017-01-25, distributed nationwide. When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled b
| Recall number | Z-1029-2017 |
|---|---|
| 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 | 2016-12-21 |
| Classified | 2017-01-13 |
| Reported by FDA | 2017-01-25 |
| Terminated | 2023-03-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, JM, MX |
Product
Fresenius 2008K@home Series : Hemodialysis System
Reason for recall
When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
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-1029-2017. 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.