B. Braun Medical Inc is recalling Dialog+ Hemodialysis Systems because they may have defective conductivity sensors that could cause improper blood filtration. The Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall reserved for products in which use may cause serious injuries or death.
The recall involves 1,033 units with the model numbers 710200L, 710200K, 710200S, 710200U, 710500L, and 710500K. The devices were manufactured April 1, 2013 to July 3, 2013 and distributed June 25, 2013 to October 7, 2015. Affected hemodialysis systems were distributed to hospitals, health facilities, and dialysis clinics in Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Kansas, Kentucky, Maryland, Missouri, New Jersey, New Mexico, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Puerto Rico, and the Virgin Islands.
Dialog+ Hemodialysis Systems are machines used in the treatment of chronic kidney disease for patients whose kidneys are no longer healthy enough to filter their blood or wastes and excess fluids. B. Braun initiated the recall because of 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. The presence of air in dialysis fluid may lead to improper blood filtration, causing serious adverse health consequences, including death.
Any adverse events related to this recall should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.