FDA, Cardinal Strike Deal On Defective Drug Pumps

Law360 (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...
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