* Some models recalled in October due to software problems
* Import of other products not affected
* Hospira sees no material impact on meeting its 2012 goals
Nov 13 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
Hospira in the filing did not say why the FDA imposed the
restriction. A Hospira spokesperson could not be immediately
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.
Hospira on Nov. 7 said it had placed a voluntary hold on
shipments of the Symbiq pumps to new U.S. customers. A day
later, the FDA notified the company of the import restriction,
Last month, the FDA said some Symbiq models were recalled
due to software issues after Hospira received reports from
customers of touch screens that were not responsive, delaying
The Lake Forest, Illinois-based maker of medical devices and
injectable specialty drugs said it will support the repair and
replacement of Symbiq pumps to existing customers.
Hospira has been working for several years to resolve
manufacturing issues at some of its plants. In February, it
resumed production of injectable drugs at its Rocky Mount, North
Carolina, plant after a maintenance shutdown. Manufacturing
problems at that plant had let to shortages of anesthesia and
other drugs for its customers.
Hospira shares were little changed in after-hours trading
from Tuesday's close of $29.60 on the New York Stock Exchange.