* Millions of recalled devices were distributed worldwide
* Air embolism or fluid leakage could cause serious injury
* Becton Dickinson says it has corrected the problem
* Company investigating reports of one death, one injury
* Becton shares up slightly (Adds details on company investigation from spokeswoman, updates shares)
By Susan Kelly
CHICAGO, Feb 8 (Reuters) - Becton Dickinson & Co (BDX.N) said it has voluntarily recalled millions of its intravenous infusion therapy devices distributed worldwide because the products could cause a potentially dangerous air embolism or fluid leakage.
Becton on Monday said it recalled certain lots of its BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems after determining their use could cause an air embolism or leakage of blood or IV therapy that could result in serious injury or death.
The company is investigating reports of one death and one serious injury that may be linked to the problem, though so far the investigation is not conclusive, said Becton spokeswoman Colleen White.
“We’re investigating two reports that may be associated with this problem,” White told Reuters.
The recall was initiated on Oct. 28, 2009 after the company received complaints of problems due to air entry through a part of the device. Becton said it notified its customers of the recall by letter and is working with the U.S. Food and Drug Administration and worldwide health agencies to coordinate recall activities.
Becton said it determined the cause of the problem to be a manufacturing deviation and said it has corrected the problem.
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.
Product failures occurred on units distributed from November 2008 through November 2009.
Becton, based in Franklin Lakes, New Jersey, said neither the costs anticipated with the recall nor the impact on its business was expected to be material.
Shares of Becton Dickinson were up 16 cents at $75.05 in late-morning trading on the New York Stock Exchange. (Reporting by Susan Kelly, Dave Zimmerman)