Monday, medical devices manufacturer Becton, Dickinson and Co. (BDX) said that it has voluntarily recalled certain lots of BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems. According to the company, use of the affected devices may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death. The company's shares fell $0.36 cents or 0.48%.
Becton, Dickinson and Co. said that this field corrective action included notification to customers worldwide by letter. It added that neither the costs anticipated with the recall, nor the impact on BD's business, are expected to be material.
The BD Q-Syte Luer Access device is intended for use with other infusion therapy products in the administration of fluids into the intravenous system. BD Nexiva has been added to the scope of this recall that was first initiated on October 28, 2009. The BD Nexiva product has two BD Q-Syte devices within the package that could potentially be subject to the manufacturing deviation previously referenced in the October 28, 2009 recall letter.
According to the Franklin Lakes, New Jersey-based company, the recall on October 28 was initiated after it received complaints due to air entry through the bottom disk of the septum. The company investigated and determined the root cause to be a manufacturing deviation.
The company noted that product failures occurred on lots of BD Q-Syte and BD Nexiva units distributed from November 2008 through November 2009. The root cause has been corrected and preventive measures, including additional inspections and preventive maintenance of the line, have been implemented.
The approximately 2.8 million BD Q-Syte and 2.9 million BD Nexiva units containing 5 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.
Becton, Dickinson said that it has notified the U.S. Food and Drug Administration or FDA and other worldwide health agencies, as necessary, and is working with them to coordinate recall activities.
BDX is currently trading at $74.53, down $0.36 or 0.48%, on a volume of 327 thousand shares on the New York Stock Exchange.
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