FDA Blocks Hospira, Inc. From Importing Infusion Pump
The U.S. Food and Drug Administration has prohibited Hospira Inc from importing its Symbiq medication infusion pumps, which are manufactured in Costa Rica, into the United States, the company said Tuesday in a regulatory filing. Hospira in the filing did not say why the FDA imposed the restriction. A Hospira spokesperson could not be immediately reached. The company said the FDA's action does not restrict importation of its other medication management products, and the company does not expect it will have a material impact on its ability to achieve its 2012 financial projections. In August, Hospira announced it received a warning letter from the FDA over quality problems at the Costa Rica plant where it makes most of its infusion pumps. Among the issues cited were alarm failures on the company's Plum brand of infusion pump. At the time, the company said it was switching alarm components for the Plum pump, which was recalled in February 2011, and expected to complete that process by early 2013.