B. Braun has issued a recall of the addEase Binary Connector, a medical device that controls the amount of medication a patient receives. The recall was precipitated by concerns that loose stopper fragments were detaching and floating in the patient’s system. This debris can cause a pulmonary embolism, stroke, heart attack, myocardial infarction and other complications.
Unlike a lot of the recalls we have seen lately with drugs, this is a Class 1 recall which means the FDA believes the device may cause severe injury or death.
The recall is not new news. The FDA first addressed the concerns with the addEase Binary Connector in June. The recall includes addEase Binary Connectors with catalog numbers N7990 and N7933. The binary connectors were manufactured and distributed between April 4, 2004 and June 4, 2010.