B. Braun Medical is voluntarily recalling its Dialog+Hemodialysis systems due to fractures in conductivity sensors that may allow air to come in contact with dialysis fluid, leading to poor blood filtration.
An FDA notice warns that the defect could lead to serious adverse events, including death. The Class 1 recall affects systems manufactured between April 1, 2013 and July 2013 and distributed between June 25, 2013 and Oct. 7, 2015. The recall involves 1,033 units.
B. Braun is advising customers to administer a pressure test and return results to the devicemaker. The device may continue to be used if no dip in pressure is identified.
In late March, the company issued a voluntary recall of its 5 percent Dextrose Injection container following customer complaints that some containers were leaking and, in a few cases, particulate matter identified to be microbial growth was discovered.