B. Braun addEASE Binary Connector: Class I Recall -Stopper Fragments May Enter Bag
MedSun: Newsletter #56, January 2011
FDA MedWatch Safety Alert
When the addEASE binary connector is inserted into a partial additive bag (PAB) stopper, fragments of the stopper may enter the bag, resulting in a small amount of visible particles in the solution. The particles can potentially enter a patient's body and lead to serious adverse health consequences, such as pulmonary embolism, stroke, or heart attack. B Braun sent an Urgent Medical Device Recall letter to its customers informing them of the recall and advising them to immediately stop using or distributing addEASE connectors.
FDA MedWatch Safety Alert. B. Braun addEASE Binary Connector: Class I Recall - Stopper Fragments May Enter Bag. November 30, 2010.