The U.S. Food and Drug Administration today announced that executives from Baxter Healthcare Corp. have signed a consent decree of condemnation and permanent injunction for certain infusion pumps made by the firm.
The company agreed to stop manufacturing and distributing within the United States all models of the Colleague Volumetric Infusion Pump and the Syndeo Patient Controlled Analgesic Syringe Pump until they correct manufacturing deficiencies and the devices are made in compliance with FDA's current good manufacturing practice requirements. The consent decree was entered today by the U.S. District Court for the Northern District of Illinois.Infusion pumps are electronic devices intended to control delivery of solutions and medications to patients. They are used in situations where medication must be administered intravenously or through other routes, in a continuous or intermittent manner, for a prolonged period of time. Under the terms of the consent decree, the company has agreed to take necessary measures to ensure FDA compliance by all of its facilities that manufacture, process, pack, label, hold or distribute the pumps. The decree also requires Baxter to retain an independent expert consultant to conduct inspections of its infusion pump facilities, as well as to certify to the FDA that corrections have been made. In turn, the FDA will allow the firm to continue to provide routine service maintenance, or to replace components, parts, or accessories for the pumps that were already in the hands of customers before October 12, 2005. If Baxter fails to comply with any provision of the decree, or violates the Act or FDA regulations, the FDA may order the firm to again stop manufacturing and distributing, recall the products or take other action.