FDA, Cardinal Strike Deal On Defective Drug Pumps

Law360, New York (February 12, 2007, 12:00 AM EST) -- Cardinal Health 303 Inc. has agreed to correct defects in its medical infusion pumps, which the U.S. Food and Drug Administration claims could cause patients to receive overly high drug doses.

The health care products maker signed a consent decree with the FDA on Thursday. Cardinal will be required to make a number of changes to the design, manufacture, packaging, labeling and distribution of its Alaris SE infusion pump, formerly known as Signature Edition Infusion System.

The FDA classified the case a Class I recall, which...
To view the full article, register now.

Law360 UK

UK Financial Services

Read Our Latest UK Legal News & Analysis

Financial Services Law360 UK and Insurance Law360 UK provide breaking news and in-depth analysis on U.K. and European Union regulation, enforcement, legislation, and litigation involving banks, investment firms, insurers, and more.