Products containing Q-Syte Luer Access Device may cause serious complications and death
THURSDAY, Feb. 11 (HealthDay News) -- Becton, Dickinson and Company (BD) and Acacia, Inc. have announced the voluntary recall of any products containing the Q-Syte Luer Access Device, including BD's Nexiva Closed Intravenous (IV) Catheter System and Acacia's IV Extension Sets. The use of affected devices may cause an air embolism or fluid leakage, which can result in serious complications and death.
In this recall first initiated on Oct. 28, 2009, BD and the U.S. Food and Drug Administration notified health care professionals of damaged lots of the Q-Syte Luer Access Device, which is a needless valve used in combination with other infusion therapy products for IV fluid administration. In addition, the Nexiva Closed IV Catheter System includes two Q-Syte devices, which may also be affected. Although Acacia has not experienced any product failures with their IV Extension Sets that include the BD Q-Syte Luer Access Device, the company initiated a recall of these devices on Dec. 18, 2009.
BD determined the problem was due to manufacturing deviation, with product failures occurring in devices distributed during November 2008 and November 2009. BD has corrected the problem and ensures the efficacy and safety of these products.
"The approximately 2.8 million BD Q-Syte and 2.9 million BD Nexiva units containing five million BD Q-Syte devices that were recalled were distributed in the United States, Asia, Canada, Europe, Mexico, the Middle East, South Africa and South America. BD has notified the U.S. Food and Drug Administration and other worldwide health agencies, as necessary, and is working with them to coordinate recall activities," the Feb. 8 press release by BD stated.