Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall
MedSun: Newsletter #47, April 2010
FDA MedWatch Safety Alert
FDA notified healthcare professionals of the Class 1 recall of certain lots of the BD Q-Syte Luer Access Split Septum device and other finished products, including Numerous Products Containing the Q-Syte Luer Access Split Septum Device, Repackaged and Distributed by Acacia Inc. (also known as MPS Acacia), Medical Action Industries, Inc., and Arrow International, Inc.
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, leakage of therapy being infused and result in incomplete inadequate administration of therapy, and a potential for blood leakage through this defect.
FDA MedWatch Safety Alert. Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall March 18, 2010.