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FDA Alert: BD announced recall of medical devices due to potential hazard

Legal news for New Jersey product liability attorneys –The FDA announced recall of Becton Dickinson and Company medical devices due to potential hazards of an air embolism.

Franklin Lakes, NJ (NewYorkInjuryNews.com) – The Food and Drug Administration (FDA) www.fda.gov has announced that Becton, Dickinson and Company (BD) has voluntarily recalled certain lots of BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems due to the potential hazard that the device may cause an air embolism or leak blood, which can result in injury or death.

The company sent out a worldwide letter that alerted professionals of the hazard risk with the devices. The Q-Syte Luer Access device was used with other fusion therapy products to give fluids intravenously. The Nexiva product, which contains two BD Q-Syte devices, also became a part of this recall after the first recall in October 28, 2009 due to a potential manufacturing deviation. The catalog numbers and the lot numbers for the U.S. and internationally, involved in the recall may be found on the FDA’s website under Safety recalls, market withdrawals, and safety alerts at http://www.fda.gov/Safety/Recalls/UCM200121.

BD announced the recall to protect patients across the world after there were complaints received about how air had entered the bottom disk of the septum. The company determined that the problem was found to be a manufacturing issue. The products were distributed from November 2008 through November 2009. The company has fixed the manufacturing issue and continues to take preventative measures such as additional inspections. There were a reported 2.8 million BD Q-Syte and 2.9 million BD Nexiva units with 5 million BD Q-Syte devices that were sold in the U.S. Asia, Europe, Mexico, Canada, the Middle East, South America and South Africa. The company continues to work with the FDA to continue recalls.

Professionals with questions may contact BD at 1-800-453-4538, option 2, extension 2585, Monday through Friday between 8:00 a.m. and 5:00 p.m. or directly at 1-801-565-2300, x2585 or x2860. For serious reactions to the quality problems with the devices, contact FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm

Bridget Hom

www.NewYorkInjruyNews.com

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