Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T Recalled by Fresenius Medical Care Renal Therapies Group, LLC Due to Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fresenius Medical Care Renal Therapies Group, LLC directly.
Affected Products
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 are indicated for acute and chronic dialysis therapy
Quantity: 8384 units (8369 US) (15 OUS)
Why Was This Recalled?
Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When Dialyzing Patients Treated with Hydroxocobalamin (or any form of Vitamin B-12)
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fresenius Medical Care Renal Therapies Group, LLC
Fresenius Medical Care Renal Therapies Group, LLC has 27 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report