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U.S. Department of Health and Human Services

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Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall

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.

Audience: Hospital risk managers

[Posted 03/18/2010] 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 kits and trays, sold by other companies in which the Q-Syte Luer Access device is a component.

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.

[03/17/2010 - Recall Notice - FDA]
[03/17/2010 - Initial Communication - FDA]

Previous MedWatch alert:

[02/09/2010