Fresenius 2008 Hemodialysis Machines Recalled for Acetate Display Error
Fresenius Medical Care is recalling 2008 Series Hemodialysis Machines because the Acetate value for GranuFlo is displayed incorrectly on the Select Concentrate screen.
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 2/5 (Moderate).
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, and 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, including the 2008Kathome and various 2008T models. The recall affects 133,751 units distributed in the United States, Canada, and Mexico.
The recall is due to a software display error where the Acetate value for GranuFlo on the Select Concentrate screen is displayed as 4mEq/l instead of the correct 8mEq/l. The correct value is displayed on the dialysate screen.
Healthcare providers and patients using these machines should verify the acetate concentration using the dialysate screen or consult the manufacturer for instructions on correcting the display error.
The recalled product
- Product
- 2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG; 190858 2008T HEMODIALYSIS SYSTEM WITHOUT CDX The Fresenius 2008K…
- 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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