Cardinal Health 303 Inc. Signs Consent Decree With FDA, Agrees To Correct Manufacturing Deficiencies
MedSun: Newsletter #12, February 2007
Cardinal Health 303 Inc. (Cardinal 303), formerly known as Alaris Medical Systems, Inc., and three of its top executives have signed a consent decree for condemnation and permanent injunction related to the company’s Signature Edition (SE) infusion pumps. The infusion pumps have a design defect referred to as "key bounce" that may cause the pump to recognize a single key stroke as a double key stroke. The "key bounce" problem poses a risk to public health because of a potential overinfusion of medications.
Under the terms of the consent decree, the company has agreed to take necessary measures to ensure compliance with the current good manufacturing practice requirements and the Quality System regulation by all of its facilities that design, manufacture, process, pack, label, hold, or distribute SE infusion pumps. The decree also requires the company to retain an independent expert consultant to conduct inspections of its SE infusion pump facilities and certify to FDA that corrections have been made. FDA will continue to monitor these activities through its own inspections.
The decree was entered in the United States District Court for the Southern District of California on February 8, 2007.
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