Becton Dickinson Intravenous Devices Recalled
Each year the number of injuries that are attributed to defective medical devices increases in the United States. On February 8, 2010, Becton Dickinson & Co. announced a voluntarily recall of millions of its intravenous infusion therapy devices distributed worldwide because the products could cause a potentially dangerous air embolism or fluid leakage, according to a recent Reuters report.
Becton 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.
The recall was initiated on October 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.
