AddEase Binary Connector Recall: Risk of Heart Attack, Stroke
B. Braun has announced a recall of the addEase Binary Connector, a device used to regulate the flow of drugs into patients’ bodies, due to risk of severe injury or death.
Notice of the binary connector recall was posted by the FDA on Tuesday, after the agency classified it as a Class 1 medical device recall. In some cases, the binary connector could potentially cause debris to flow into a patient’s body, possibly causing pulmonary embolism, stroke or heart attack.
A Class 1 recall designation means that the FDA has determined that the defective medical device is likely to cause severe injury or death. The recall notice did not indicate whether there have been any injuries or deaths associated with the defective addEase binary connectors.
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The binary connectors are used in both standard syringes and with syringes that have a partial additive bag that transfers additional drugs into the syringe’s drug vial. In cases where the connectors are used with the partial additive bag, it is inserted into a stopper in the bag. That could cause debris from the stopper to enter the patient’s blood stream.
On June 28, B Braun sent a letter to customers advising them to immediately stop using or distributing the devices, which the FDA determined constituted a Class 1 recall last month.
The recall includes addEase Binary Connectors manufactured by B. Braun with catalog numbers N7990 and N7933. The binary connectors were manufactured and distributed between April 4, 2004 and June 4, 2010.
The company has contacted its customers and distributors and has asked them to return any full or partial cases through its customer support department. They asked that any individual units that have been removed from the cases simply be destroyed.
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