Fresenius Medical Care Holdings, Inc. recalls 2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System -…

Recall date

February 20, 2015

Source

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

Recall number

Z-1550-2015

FDA classification

Class II

Brand / firm

Fresenius Medical Care Holdings, Inc.

Sold / distributed

Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico.

Why it was recalled

The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.

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

What was recalled

2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395 2008KatHOME MACHINE, SHORT CAB, OLC/DP, HP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.