B. Braun just issued a recall of its addEASE Binary Connector, catalog numbers N7990 and N7933. The U.S. Food and Drug Administration (FDA) has labeled this a Class I Recall. The addEASE is used to transfer fluid between a partial additive bag (PAB) and a drug vial.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
When the addEASE binary connector is inserted into a 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 patientâ€™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 recalled addEASE Binary Connectors were manufactured and distributed from April 4, 2004 to June 4, 2010
Braun PAB containers can continue to be used safely with a standard syringe and needle in accordance with the Direction for Use.
On June 28, 2010 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. B. Braun requested that its customers contact the Customer Support Department to arrange for return of any full or partial cases of addEASE. A Customer Support Representative will provide customers with instructions for handling the affected product and the firm will arrange for unopened cases to be returned to B. Braun Medical, Inc. for proper disposal. Individual units (out of shipping cases) may be destroyed at the customerâ€™s facility.
For questions about the affected product or information on returning unused addEASE binary connectors, contact B. Braun Customer Support Department, toll-free, atâ€¨800-227-2862 â€¨Monday through Friday from 8:00 a.m. to 7:00 p.m., Eastern Standard Time. Braun Clinical and Technical support is also available for issues with particulates in the PAB after use of an addEASE binary connector and can be reached, toll-free, at1-800-854-6851.
Healthcare professionals are encouraged to report adverse events related to the use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online here.