B. Braun addEASE Binary Connector Recalled

Washington, DC: A class I recall has been issued for the B. Braun addEASE Binary Connector, because 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. These issues could result in serious injury or death.

The addEASE is used to transfer fluid between a partial additive bag (PAB) and a drug vial.

NOV-30-10: B. Braun addEASE Binary Connector: Class I Recall -Stopper Fragments May Enter Bag [FDA: Medwatch]

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Published on Nov-30-10