Fresenius 2008K Hemodialysis Machines Recalled for Acetate Display Error
Fresenius Medical Care is recalling 2008K hemodialysis machines because the GranuFlo acetate value is incorrectly displayed as 4mEq/l instead of 8mEq/l on the Select Concentrate screen.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a display error where the correct value is available on a different screen, representing a low-risk contamination or labeling issue without reported injuries.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 2008 Series Hemodialysis Machines, specifically the 2008K model, due to a software display error. The recall affects 133,751 units distributed in the United States, Canada, and Mexico.
The issue involves the display of the Acetate value for GranuFlo on the Select Concentrate screen. The value is displayed as 4mEq/l, but the correct value is 8mEq/l. The correct value is properly shown on the dialysate screen. The 2008K machines are indicated for acute and chronic dialysis therapy.
The recall is classified as Class II by the FDA. Consumers and healthcare facilities should verify the serial numbers of their machines against the provided list and contact the manufacturer for instructions on correcting the display error.
The recalled product
- Product
- 2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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