DEERFIELD, Ill., Dec. 14 /PRNewswire-FirstCall/ -- Baxter Healthcare Corporation announced today that it has received conditional approval for the COLLEAGUE infusion pump corrective action plan from the U.S. Food and Drug Administration (FDA) and that it has submitted an updated 510(k) pre-market notification filing with FDA. The company anticipates receiving the FDA's response to the notification within 90 days. Baxter plans to begin deployment of the corrective actions in the U.S. following FDA's final approval of the corrective action plan, which is conditioned upon successful 510(k) clearance.
"Reaching these milestones with the COLLEAGUE infusion pump reflects our commitment to resolving reliability and user interface issues associated with these critical devices and restoring our customers' confidence by delivering high quality, innovative infusion technologies," said Robert L. Parkinson, Jr., Baxter's chairman and chief executive officer. "We appreciate our customers' patience as we've worked to resolve these issues and we look forward to deploying our corrective actions upon receiving 510(k) clearance."
Pumps currently in the market continue to be safe to use when operated according to the user manual and instructions contained in previous customer communications. Currently, more than 200,000 COLLEAGUE infusion pumps are in use in U.S. hospitals and over 50,000 are used abroad.
Deployment of COLLEAGUE pump modifications outside the U.S. is nearly complete, with 50,000 pumps in 49 countries upgraded. To date, 29 countries have fully completed deployment and COLLEAGUE pump sales have resumed in 37 countries.
In June 2006, Baxter and FDA reached agreement in the form of a consent decree on steps Baxter must take to resume sales of new COLLEAGUE infusion pumps in the U.S. The agreement resolved a court action by the FDA that began with a seizure of COLLEAGUE pumps in Baxter's northern Illinois warehouses in October 2005, which followed field corrective action notices issued by Baxter about design and user interface issues. Issues identified in the field corrective actions are addressed in Baxter's comprehensive correction action plan and new 510(k) submission.
Baxter Healthcare Corporation is a subsidiary of Baxter International Inc. (NYSE: BAX - News). 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 our expectations regarding the timing of the FDA's response to our 510(k) pre- market notification and completion of the deployment of pump modifications outside the U.S. 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; changes in laws or regulation; numerous other matters of national, regional and global scale, including those of a political, economic, business, competitive and regulatory nature 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 International Inc.
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