Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
2008 K2 Hemodialysis Machine with software version 5.40 Recalled by Fresenius Medical Care Renal Therapies Group, LLC Due to When the recirculation ultrafiltration (UF) Goal is set...
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
2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy.
Quantity: 127
Why Was This Recalled?
When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation UF rate which may be up to 4000ml/hour. The SLED program is required to limit the UF rate to a maximum of 1000 ml/hour.
Where Was This Sold?
This product was distributed to 16 states: AR, CA, CO, FL, GA, IL, MD, MA, MN, NY, NC, OH, PA, SC, TN, TX
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