* Some models recalled in Oct. 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. It 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.
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 touchscreens that were not responsive, delaying
Hospira said it will support the repair and replacement of
Symbiq pumps to existing customers.
Hospira shares were little changed in after-hours trading
from Tuesday's close of $29.60 on the New York Stock Exchange.