Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius 2008K2 Series : Hemodialysis System

Recall date

December 21, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1028-2017

FDA classification

Class II

Brand / firm

Fresenius Medical Care Renal Therapies Group, LLC

Sold / distributed

Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Fresenius 2008K2 Series : Hemodialysis System