FDA Device recall Z-1027-2017
Fresenius 2008K Series : Hemodialysis System
- FDA Device
- Class II
- terminated
- Published 2017-01-25
On 2017-01-25 the FDA classified a Class II recall of Fresenius 2008K Series : Hemodialysis System by Fresenius Medical Care Renal Therapies Group, citing 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 exec….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1027-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-21 |
| Published | 2017-01-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Fresenius Medical Care Renal Therapies Group |
| Distribution | US |
Product
Fresenius 2008K Series : Hemodialysis System
Reason
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
Identifiers
| code_info | All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Fresenius Medical Care Renal Therapies Group
- CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors
FDA Device · Class II · 2026-09-30 · Fresenius Medical Care Renal Therapies Group - 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 1…
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
All Fresenius Medical Care Renal Therapies Group recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1027-2017%22
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