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Hemodialysis System Recall - Defective Conductivity Sensors; Injury to Kidney Patients


On May 4, 2016, B. Braun Medical Inc. recalled 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. 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 a machine used in the treatment of chronic kidney disease for patients whose own kidneys are no longer healthy enough to filter their blood of wastes and excess fluid. These systems are used in hospitals, health centers, and in outpatient dialysis center settings.

 

The recalled products were manufactured between April 1, 2013, and July 3, 2013. The recalled products were distributed between June 25, 2013, and October 7, 2015. The recalled products include model numbers 710200L, 710200K, 710200S, 710200U, 710500L, and 710500K.

 

The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

 

See the FDA Safety Alert

 

See the Recall

 

 

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