Fresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
Fresenius Medical Care is recalling 1,140 BlueStar Hemodialysis machines due to reported flow, water, or temperature-related alarms.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device (hemodialysis machine) with reported functional defects (alarms) that could compromise patient safety, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 1,140 units of the 2008T BlueStar Hemodialysis Machine, specifically model numbers 191126 and 191130. The recall covers systems distributed nationwide in the United States.
The recall was initiated after the company received complaints regarding flow-, no water-, or temperature-related alarms on the affected machines. These alarms indicate potential issues with the machine's ability to properly monitor or control the dialysis process.
Healthcare facilities and consumers with these specific model numbers should stop using the machines and contact Fresenius Medical Care for instructions on repair or replacement. The recall number is Z-3017-2026.
The recalled product
- Product
- Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
- Hazard
- Affected units
- 1,140
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 191126
- UDI/DI 00840861102099
- Serial Numbers: 5T0S291116
- 5T0S291119
- 5T0S291125
- 5T0S291135
- 5T0S291137
- 5T0S291138
- 5T0S291139
- 5T0S291140
- 5T0S291141
- 5T0S291143
- 5T0S291144
- 5T0S291145
- 5T0S291146
- 5T0S291148
- 5T0S291149
- 5T0S291150
- 5T0S291151
- 5T0S291152
Distribution
Distributed nationwide across the United States.
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