Certain lots of the BD Q-Syte Luer Access Split Septum device and other finished products including kits and trays sold by other companies in which the Q-Syte Luer Access device is a component, are being recalled because they are defective and may cause serious injury for patients, according to a Food and Drug Administration (FDA) announcement. This Class 1 recall affects four products used with other infusion therapy products to administer therapies (such as chemotherapy), blood and fluids into the intravenous (IV) system. A Class 1 recall is the most serious type of recall issued by the FDA and is reserved for products where there is a potential for serious injury or death.
The recall covers certain lots of the following products: BD Q-Syte Luer Access Split Septum devices; BD Nexiva Closed IV Catheter Systems; MPS Acacia IV Extension Sets; and Medical Action Industries IV start, venous access trays and dialysis kits.
The recall was initiated by BD Medical Systems, Medical Action Industries, Acacia Inc., and Arrow International. The defect may result in air bubbles leaking into the infusion system and into the patient’s bloodstream, which would result in an air embolism. The defective devices may also result in leakage of therapy being infused and result in incomplete and inadequate administration of therapy. There is also a potential for blood leakage through this defect. These problems may result in serious injuries or death.
Problems with these or any other medical devices should be reported to the FDA MedWatch Adverse Events Reporting program at www.FDA.gov/MedWatch.