Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Fresenius 2008K@home Series : Hemodialysis System Recalled by Fresenius Medical Care Renal Therapies Group, LLC Due to When the UF Rate, Goal or Time is...

Date: December 21, 2016
Company: Fresenius Medical Care Renal Therapies Group, LLC
Status: Terminated
Source: FDA (Device)

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 2008K@home Series : Hemodialysis System

Quantity: 1400 units (US) 556 units (OUS)

Why Was This Recalled?

When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Fresenius Medical Care Renal Therapies Group, LLC

Fresenius Medical Care Renal Therapies Group, LLC has 27 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report