Recalls

Infusion therapy products recalled due to risk of serious injury, death

The Food and Drug Administration (FDA) is warning health care professionals about a recall of BD Q-Syte Luer Access Devices, a needleless valve, and BD Nexiva Closed IV Catheter Systems, both manufactured by BD. The devices are intended for use with other infusion therapy products to administer fluids into the intravenous system. Use of the devices may cause an air embolism or leakage of blood or therapeutic product, which may cause serious injury or death.

The recall affects specific lots of Acacia Inc.’s BD Q-Syte Luer Access Devices, BD Nexiva Closed IV Catheter Systems, and Acacia IV Extension Sets with BD Q-Syte Luer Access Devices. The recalled units were distributed worldwide from November 2008 through November 2009. The recall affects approximately 2.8 million BD Q-Syte, 2.9 million BD Nexiva and 217,000 IV Extension Sets with BD Q-Syte.

Acacia first initiated recalls of the products in fall 2009 after the company received complaints of air entry with use of some lots of the products. The company has since expanded the recall. BD reports that the root cause of the problem has been identified and corrected by BD and preventive measures, including additional inspections and preventive maintenance of the product line, have been implemented.

Any adverse events related to this or any other device should be reported to the FDA’s MedWatch Adverse Events Reporting System at www.fda.gov/medwatch