December 3, 2010 – B. Braun, in cooperation with the U.S. Food and Drug Administration (FDA), has initiated a voluntary recall of addEASE Binary Connectors. The binary connectors are intended to be inserted into a partial additive bag (PAB) stopper to transfer fluids between the bag and a drug vial. The drugs within the vial are then injected into the patient. It is possible that the binary connectors could cause fragments of the PAB stopper to be pushed into the fluid within the PAB, and consequently, the patient. If these visible, floating particles enter the patient’s body, they could cause serious adverse health effects such as a pulmonary embolism, stroke or heart attack. The affected connectors were distributed nationwide between April 4, 2004 and June 4, 2010.
The addEASE Binary Connectors affected by this recall include the following catalog numbers:
- N7990; and
B. Braun has sent an Urgent Medical Device recall letter to all of its customers. Customers have been advised to cease use of the connectors immediately and contact B. Braun immediately for instructions regarding proper disposal of the defective devices. Continued use of the PAB containers with a standard syringe and needle in accordance with safety standards is still permissible. This is a Class 1 recall, meaning that the recall involves a situation in which continued use of the product may result in serious adverse health consequences or even death. A Class 1 recall is the most serious type of recall.
Contacting a New York Product Liability Lawyer
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