CareFusion has received the permission from FDA to resume manufacturing and marketing of its 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.
David Schlotterbeck, chairman and CEO of CareFusion, said: “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. While we still have work to do under our consent decree, we are pleased to have reached this important milestone.”
The company develops technologies including Alaris IV pumps, Pyxis automated dispensing and patient identification systems, AVEA and Pulmonetic Systems ventilation and respiratory products, ChloraPrep products, MedMined services for infection surveillance, NeuroCare neurological monitoring and diagnostic products, V. Mueller surgical instruments, and an extensive line of products that support interventional medicine.