Fresenius 2008T BlueStar Hemodialysis Machine
Fresenius recalls 2008T BlueStar Hemodialysis Machine over flow, no water, and temperature alarms.
Contact Fresenius Medical Care Renal Therapies Group, LLC for instructions on addressing the alarm issues. Do not use the machine if it is experiencing these alarms until corrective action has been taken.
Recall at a glance
- Quantity recalled
- 1140 systems
Why it was recalled
Fresenius Medical Care Renal Therapies Group, LLC is recalling the 2008T BlueStar Hemodialysis Machine due to reports of flow-, no water-, or temperature-related alarms. These alarms may interrupt treatment and potentially compromise patient safety.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
- UDI-DI
- 00840861102099
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
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Editorial summary by Recall Canary · summary updated 2026-08-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification