Consent Decree Expanded to Include All of Cardinal’s Infusion Pumps

March 13, 2009
The FDA and Cardinal Health have agreed to expand the company’s consent decree related to the manufacture of the Alaris SE line of infusion pumps to include all infusion pumps marketed by the company’s Cardinal Health 303 subsidiary.

The expanded consent decree does not apply to IV administration sets and accessories, the company says in an SEC filing. “Further, it does not prohibit Cardinal Health 303 from continuing to manufacture, market and sell infusion pumps (other than the Alaris SE pumps, which were covered under the original consent decree),” the filing says.

The updated decree was announced in a company statement and by the FDA last month. It comes after a January 2008 FDA inspection of Cardinal Health infusion pump operations that found certain devices were in violation of the Federal Food, Drug, and Cosmetic Act, the company says.
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