Fresenius 2008 Series Hemodialysis Machines Recalled for False Blood Leak Alarms
Fresenius Medical Care is recalling 2008 Series hemodialysis machines because they may trigger false blood leak alarms when treating patients with Vitamin B-12.
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 involves false alarms rather than direct physical injury or contamination, fitting the criteria for moderate severity.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling the Fresenius 2008 Series Hemodialysis Delivery Systems, including the 2008T, 2008K2, 2008K, and 2008K@home models. The recall involves 8,384 units distributed nationwide, with 8,369 units in the United States and 15 units outside the US.
The recall was initiated because the machines may generate false blood leak alarms when dialyzing patients who are treated with hydroxocobalamin or any form of Vitamin B-12. This issue is specific to the interaction between the dialysis process and the presence of Vitamin B-12 in the patient's treatment.
Healthcare facilities and consumers using these devices should contact Fresenius Medical Care for instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine The Fresenius 2008¿ Series Machines…
- Hazard
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 (2)
- Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T
- 2008K2
Distribution
Distributed nationwide across the United States.
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