Consent Decree Expanded to Include All of Cardinal’s Infusion Pumps
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.
The GMP Letter