Cardinal Health and the U.S. Food and Drug Administration updated the public on a worldwide recall of Alaris Pump modules today, informing consumers that the medicine-infusion systems may overinfuse, which could prompt serious, life-threatening side effects. The Alaris Pump recall involves model number 8100, which was formerly known as the Medley Pump.

According to the FDA’s statement on December 20, 2007, the recalled Cardinal Health Alaris Pumps may contain occluder springs that are bent, broken, nested, or missing. This could cause the pump to malfunction, and perhaps lead to overinfusion of medicine. But according to the FDA, overinfusion can be difficult to detect because there is no warning or notification from the pump itself that it is injecting too much medicine.

Cardinal Health has received one injury report and two reports of patient deaths associated with use of the recalled Alaris Pumps, however the company maintains that neither they nor the respective hospitals could confirm that use of the device definitively caused the deaths.

The FDA urges consumers to contact Cardinal Health with any inquiries related to the recall. The company’s phone number is 1-800-625-6627, and its Web site is www.cardinalhealth.com. According to Cardinal Health, it will have representatives answering phones around the clock, seven days a week.

Source: U.S. Food and Drug Administration, “Cardinal Health Statement on Alaris Pump Module Worldwide Voluntary Recall,” December 20, 2007.