Fresenius 2008T BlueStar Hemodialysis Machines Recalled for USB False Alarm
Fresenius Medical Care is recalling 15,342 hemodialysis machines because a false alarm may appear when a USB device is connected.
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, but the hazard is a false alarm that does not directly cause physical injury or death, fitting the criteria for moderate severity involving minor operational errors.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 15,342 units of the Fresenius 2008T BlueStar Hemodialysis Machine. The recall covers specific part numbers including 191124, 191126, 191128, and 191130. The affected units were distributed nationwide as well as in Canada, Curaca, and Guam.
The recall is due to a software issue where a "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine. This false alarm does not indicate a physical malfunction of the dialysis treatment itself but may cause confusion for operators.
Healthcare facilities and users should contact Fresenius Medical Care for instructions on how to resolve the issue. The agency has classified this as a Class II recall, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.
The recalled product
- Product
- Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 15,342
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 (1)
- All serial numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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