"Hospira is now able to sell these infusion devices to new and existing customers without medical necessity certificates, and will resume the importation of these devices into the United States immediately," the Lake Forest, Ill.-based company said.
The FDA slapped Hospira with a warning letter in August 2012, citing the Sept. 2011 recall of some of the company’s Plum drug pumps. Hospira pulled more pumps off the shelves in October 2013, a month before the safety watchdog banned U.S. imports of Hospira’s Symbiq devices made at the plant in La Aurora de Heredia, Costa Rica; the ban was extended to the Plum, GemStar and LifeCare PCA brand pumps in February 2013.
The lifting of the import ban means Hospira can start selling them again in the U.S. right away, the company said.
“Hospira is now able to sell these infusion devices to new and existing customers without medical necessity certificates, and will resume the importation of these devices into the United States immediately," according to a press release.
"Globally, we know our customers depend upon Hospira’s products and we are pleased to be returning these devices to the market. We strive to continuously improve the performance of our products and meet the expectations of both customers and regulatory agencies. This is an important milestone in that process," medical devices president David Endicott said in prepared remarks. "In 2015, we expect that our continued efforts to streamline and modernize our portfolio will result in a number of key product launches, with Hospira ultimately providing the most advanced and intuitive pumps in the industry."
Hospira also said it plans to introduce 2 new infusion pumps this year, the SapphirePlus and Plum 360, as well as an upgrade to its MedNet safety software. The company is also working with Q Core Medical to develop a next-generation pump platform built on the Sapphire and Plum technologies, according to the release.
HSP shares were up 1.4% to $61.96 today in mid-morning trading.
Material from Reuters was used in this report.