FDA dubs recall for B. Braun hemodialysis system as Class I

B. Braun's Dialog+ Hemodialysis System

B. Braun Medical has recalled a hemodialysis system to treat chronic kidney disease patients that could allow air to enter the dialysis solution. This could lead to improper blood filtration as well as other consequences including death--so the FDA has now given the recall its most serious designation of Class I.

The recall encompasses more than 1,000 of the company's Dialog+ Hemodialysis Systems. It's across 6 models that were distributed through Oct. 7, 2015 in the U.S.

The company issued a customer letter on the recall on April 1. It advised customers to have a technician run a pressure test using specific instructions in the letter. If there is no drop in pressure is found, it advised customers to tag the machine and continue its use. If there is air leakage, B. Braun is providing part replacement for the dialysis system.

"B. Braun Medical is recalling the Dialog+ Hemodialysis System due to cracks in conductivity sensors that may allow air to enter into the solution (dialysis fluid or dialysate) used to help filter waste and other excess fluids in the blood," described the FDA in a May 4 notice. "The presence of air in dialysis fluid may lead to improper blood filtration, causing serious adverse health consequences, including death."

The Dialog+ Hemodialysis System is designed to be highly configurable, enabling customizable dialysis treatment. Braun entered into a 2013 partnership with dialysis provider DaVita Healthcare Partners to supply the system.

B. Braun focuses on anesthesia products, such as peripheral nerve blocks, epidurals, spinals and pain pumps. It also has infusion, oncology, surgery and emergency medicine products.

- here is the FDA notice