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

Recalled April 13, 2016 · FDA recall Z-1325-2016 · Fresenius Medical Care Renal Therapies Group

Hazard

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) · FDA Class II

Units

8384 units (8369 US) (15 OUS)

Sold at

Nationwide Distribution

Description

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)

Product

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

Manufacturer(s)

Fresenius Medical Care Renal Therapies Group, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →