Fresenius 2008K2 Hemodialysis Machines Recalled for Acetate Display Error
Fresenius Medical Care is recalling 2008K2 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
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 is classified as FDA Class II. While the source does not explicitly state that no injuries were reported, it describes a display error where the correct value is available on another screen, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported or is theoretical.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 2008 Series Hemodialysis Machines, specifically the 2008K2 model, due to a software display error. The affected units are indicated for acute and chronic dialysis therapy.
The recall is issued because the Acetate value for GranuFlo on the Select Concentrate screen is displayed as 4mEq/l, whereas the correct value is 8mEq/l. The source text notes that the correct value is shown on the dialysate screen. A total of 133,751 units are affected, distributed in the United States, Canada, and Mexico.
Healthcare facilities and users should check their serial numbers against the list provided in the official recall notice to determine if their equipment is affected. The recall is classified as FDA Class II.
The recalled product
- Product
- 2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO SYSTEM, OPTIONAL MODULE; 190618 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH; 190610 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; 190630 2008K2 MACHINE, SHORT CAB, OLC/DP, HP; 1
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
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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