Class I Recall for BD Q-Syte Luer Access Split Septum Device Products

A Class I recall has been issued for the <"">Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device, including numerous products containing the Q-Syte Luer Access Split Septum Device, the U.S. Food and Drug Administration (FDA) just announced. The recalled items were repackaged and distributed by Acacia Inc. (also known as MPS Acacia), Medical Action Industries, Inc., and Arrow International, Inc.

The FDA advised hospital risk managers that this Class 1 recall involves 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 recalled 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.

The defective lots of the BD Q-Syte Luer Access Split Septum devices 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, the list of recalled devices can be
found in the appendix of the Initial Communication at:

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