B. Braun Medical is recalling its Dialog+ Hemodialysis systems due to an issue with defective conductivity sensors.
The federal watchdog labeled the recall as a Class I, the most serious type of recall issued by the FDA, which indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The company is recalling the Dialog+ hemodialysis systems due to cracks in the conductivity sensors that may allow air to enter into the dialysis fluid or dialysate soltuion used to help filter waste and excess fluids in the blood, according to an FDA release.
Air in the dialysis fluid can lead to improper blood filtration which could cause adverse health consequences, including death, the agency said.
The company is recalling units with model numbers 710200L, 710200K, 710200S, 710200U, 710500L, 710500K that were manufactured between April 1, 2013 and July 3, 2013 and distributed between June 25, 2013 and October 7, 2015.
A total of 1,033 units in the U.S. are being recalled, distributed to 29 states, as well as Puerto Rico and the Virgin Islands.
B. Braun said it sent an “Urgent Medical Device Correction” letter to affected customers asking them to inform potential users of the issue, identify affected units in inventory and have a qualified service tech run pressure tests using instructions attached to the letter.
The company told customers to tag the machines and continue to use them if no drop in pressure was identified, and to contact the company for part replacement if air leakage was identified.