UPDATE 1-Hospira says FDA blocks import of Symbiq infusion pump
* 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 (Reuters) - 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. 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, Hospira said.
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 therapy.
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.
- With no sign of missing plane, search spreads far across land and sea |
- Malaysia military source says missing jet veered to west |
- Toddler found with heroin at New Jersey daycare center
- UPDATE 1-Missing Malaysian plane last seen at Strait of Malacca-source
- Ukraine appeals to the West as Crimea turns to Russia |