DeviceSignal · Recall classified
Fresenius Medical Care Renal Therapies Group, LLC
FDA classified a device recall on 2026-08-26 · Class II · Z-3017-2026
EventRecall classified
Effective2026-08-26
ClassificationClass II
On 2026-08-26 the FDA classified a device recall from Fresenius Medical Care Renal Therapies Group, LLC as Class II. Product: Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126…. Recall Z-3017-2026. The firm initiated it on 2026-06-30. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3017-2026
- Classification
- Class II
- Classified on
- 2026-08-26
- Initiated on
- 2026-06-30
- Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Reason
- Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.
- Product
- Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-3017-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
09c0afaa1b8804fa5833e1cd322fb74ed161e68cde030796e298e2d6122a33e8- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)