FRANKLIN LAKES, N.J. (AP) -- Medical products company Becton Dickinson and Co. said Monday it expanding a recall for catheter devices because a manufacturing problem could cause potentially fatal embolisms or blood leakage.
The company is recalling lots of its Q-Syte Luer Access Devices and Nexiva Closed IV Catheter Systems. The Q-Syte devices are used with intravenous systems, and the Nexiva products have two Q-Syte devices within the package that could be affected.
Becton Dickinson said it doesn't expect the recall to impact costs or its business. The initial recall started Oct. 28, 2009 and the root cause of the manufacturing problem has been corrected, the company said.
The company said about 2.8 million Q-Syte and 2.9 million Nexiva units containing 5 million Q-Syte devices that were recalled were distributed in the U.S., Asia, Canada, Europe, Mexico, the Middle East, South Africa and South America.
Becton Dickinson said it is working with the Food and Drug Administration and worldwide health agencies to coordinate the recall.
Clinicians or distributors with questions can contact Becton Dickinson, and adverse reactions or quality problems experienced with the use of the products can be reported to FDA's MedWatch Adverse Event Reporting at www.fda.gov/medwatch/report.htm or by mail using a postage-paid FDA form 3500 available at: www.fda.gov/medwatch/getforms.htm