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U.S. Department of Health and Human Services

Safety

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BD Q-Syte Luer Access Devices: Recall

BD Q-Syte Luer Access Devices
BD Nexiva Closed IV Catheter Systems
Acacia IV Extension Sets with BD Q-Syte Luer Access Device

Audience: Hospital risk managers, nursing services managers 

[Posted 02/09/2010] BD, Acacia Inc. (known as MPS Acacia), and FDA notified healthcare professionals of the recall of certain lots of  these devices. The BD Q-Syte Luer Access Device is a needleless valve manufactured by BD, intended for use with other infusion therapy products in the administration of fluids into the intravenous system. Use of the recalled devices may cause an air embolism or leakage of blood or therapeutic product which may result in serious injury or death. The REF/catalog and lot numbers which were sold in the US are noted in the firm's press release. The affected lots were distributed from November 2008 through November 2009.

Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178].

[02/08/2010 - Press Release - Becton, Dickinson and Co.]
[02/09/2010 - Press Release - Acacia, Inc.]