SAN DIEGO, Jan. 11 CareFusion (NYSE: CFN), a leading, global medical device company, announced today that the Food and Drug Administration (FDA) has given the company permission to resume manufacturing and marketing the Alaris® SE line of infusion pumps (also known as the Signature Edition® infusion pump).
CareFusion, formerly the Clinical and Medical Products division of Cardinal Health, has been operating under a consent decree with the FDA since February 2007. The consent decree included an injunction on the manufacture and sale of the Alaris SE pump. The FDA recently notified CareFusion that the injunction has been lifted, allowing the company to resume sales of the Alaris SE pump.
"We have worked diligently over the past several years to improve our quality system and to complete the necessary steps to resume the production, sale and installation of the Alaris SE pump," said David Schlotterbeck, chairman and CEO of CareFusion. "While we still have work to do under our consent decree, we are pleased to have reached this important milestone."
About CareFusion Corporation
CareFusion (NYSE: CFN) is a global corporation serving the health care industry with products and services that help hospitals measurably improve the safety and quality of care. The company develops market-leading technologies including Alaris® IV pumps, Pyxis® automated dispensing and patient identification systems, AVEA® and Pulmonetic Systems ventilation and respiratory products, ChloraPrep® products, MedMined(TM) services for infection surveillance, NeuroCare neurological monitoring and diagnostic products, V. Mueller® surgical instruments, and an extensive line of products that support interventional medicine. CareFusion employs more than 15,000 people across its global operations. More information may be found at www.carefusion.com.
SOURCE CareFusion Corporation