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.

Additional Information:

FDA MedWatch Safety Alert. B. Braun addEASE Binary Connector: Class I Recall - Stopper Fragments May Enter Bag. November 30, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm235283.htm


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