April 1, 2016: B. Braun Dialysis Systems Recall Due Defective Conductivity Sensors

Dialysis Systems Recall

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for the B. Braun Medical Inc Dialog+ Hemodialysis Systems due to defective conductivity sensors. A Class I recall is the most serious type of recall; use of these devices may cause serious injuries or death.

The recall was warranted by defective, cracked conductivity sensors, which could “allow air to enter into the solution (dialysis fluid or dialysate) used to help filter waste and other excess fluids in the blood,” according to the FDA. If air adulterates the dialysis fluid, this may lead to improper blood filtration. This error could cause serious adverse health consequences, including death.

Dialog+ Hemodialysis Systems Conductivity Sensors

Dialog+ Hemodialysis Systems Conductivity Sensors are used to treat patients with chronic kidney disease. The device is used for the clinical purification of blood as a substitute for the kidney’s normal function for patients whose own kidneys are no longer healthy enough to filter their blood of wastes and excess fluid.

B. Braun Dialysis Systems Recall Details

This recall effects 1,033 units across 32 states and territories. See the entire recall here.

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