Healthcare Industry News: Baxter International
News Release - February 27, 2007
Baxter Receives 510(k) Clearance From FDA For COLLEAGUE Infusion PumpsBaxter Prepares to Upgrade COLLEAGUE Pumps in the U.S.
DEERFIELD, Ill., Feb. 27 (HSMN NewsFeed) -- Baxter Healthcare Corporation announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) on its COLLEAGUE infusion pump 510(k) pre-market notification. The company is preparing to modify pumps currently in the market and will soon submit manufacturing and service documentation to FDA in advance of deploying upgrades to U.S. COLLEAGUE infusion pumps. Baxter will continue to communicate and work directly with customers in the coming months to establish deployment schedules and begin remediation activities.
"Resolving issues with the COLLEAGUE infusion pump has been Baxter's top priority. We appreciate customers' continued support as we've worked to develop modifications for the COLLEAGUE infusion pump," said Peter Arduini, corporate vice president and president of Baxter's Medication Delivery business. "Baxter remains committed to our infusion systems customers and will continue to invest in this business to enhance the delivery of life- saving medications."
Baxter has completed deployment activities in key markets outside the U.S., with 58,000 pumps in 55 countries upgraded, and then resumed sales of COLLEAGUE infusion pumps in these markets.
In June 2006, Baxter and FDA reached agreement in the form of a consent decree, which describes steps Baxter must take to resume sales of new COLLEAGUE infusion pumps in the U.S. Currently, more than 200,000 COLLEAGUE infusion pumps are in use in U.S. hospitals.
Baxter Healthcare Corporation is a subsidiary of Baxter International Inc. (NYSE: BAX ). Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with treatment of complex medical conditions, including hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other conditions. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.
This release includes forward-looking statements concerning our remediation efforts with respect to the COLLEAGUE infusion pump including deployment of pump modifications. These statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: future actions of the FDA and other regulatory bodies and government authorities, including the imposition of any sanctions available under the Consent Decree entered with the FDA; product quality or patient safety concerns as we prepare for deployment; changes in laws or regulation; and other risks identified in Baxter International Inc.'s most recent filing on Form 10-Q and other SEC filings, including those factors described under the caption "Item 1A. Risk Factors" in the company's Form 10-K for the year ended December 31, 2005, all of which are available on the company's website. The company does not undertake to update its forward-looking statements.
Source: Baxter Healthcare
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.