Life Sciences

Cardinal Health modifies consent decree with FDA

Device Regulation Alert: Safety, Compliance and Reimbursement News, March 2, 2009

Cardinal Health will thoroughly review all of its infusion pump products within 60 days and submit a corrective action plan to the FDA that outlines all planned modifications to any infusion pump products, according to a company release.

Cardinal Health has been operating under a consent decree for its Alaris SE pump since February 2007. As part of the agreement, Cardinal Health implemented a new quality system on April 2, 2008.

Read more about Cardinal Health's modified consent degree.

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