This device is used with other infusion therapy products to administer therapies, such as chemotherapy, blood and fluids into the intravenous system. The affected BD products were distributed from August 1, 2008 through February 1, 2010.
These lots of the BD Q-Syte Luer Access Split Septum devices are defective, which may result in air bubbles leaking into the infusion system and into the patient's bloodstream, resulting in an air embolism. In addition, these defective devices may result in leakage of therapy being infused and result in incomplete inadequate administration of therapy. There is also a potential for blood leakage through this defect. These problems may result in serious injuries or death.
For specific information on the affected products, see the list of recalled devices in the appendix of the Initial Communication.