Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2…

Recall date

March 10, 2016

Source

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

Recall number

Z-1325-2016

FDA classification

Class II

Brand / firm

Fresenius Medical Care Renal Therapies Group, LLC

Sold / distributed

Nationwide Distribution

Why it was 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)

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 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