DEERFIELD, Ill., October 13, 2005 – Baxter Healthcare Corporation reported today that the U.S. Food and Drug Administration (FDA) has seized approximately 6,000 Baxter-owned COLLEAGUE® Volumetric Infusion Pumps and approximately 850 SYNDEO® PCA Syringe Pumps currently on hold at two facilities in Northern Ill. Baxter had placed a voluntary hold on shipments of new COLLEAGUE and SYNDEO pumps earlier this year.
This action affects Baxter-owned inventory. It does not affect customer-owned pumps currently being serviced by Baxter. In addition, at this time, the company is unable to provide loaner pumps to customers who have removed pumps from service in connection with previously communicated field corrective actions, or which may have been removed for other reasons. COLLEAGUE and SYNDEO pumps currently in use should be used as directed by the Operator's Manual and all field corrective actions previously communicated by Baxter.
As previously announced, the company has developed an aggressive corrective action plan and remains in discussions with the FDA concerning these issues.
“The quality of our products is our highest priority,” said Robert L. Parkinson, Jr., chairman and chief executive officer. “We are committed to working with the agency and our customers to resolve these issues as quickly as possible.”
Approximately 250,000 COLLEAGUE infusion pumps are currently in use worldwide, including more than 200,000 in the United States. There are approximately 5,000 SYNDEO pumps in use worldwide.
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 the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. 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 the company's pumps. The 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 regulatory bodies and other governmental authorities, including the FDA and foreign counterparts that could substantially affect the nature or timing of the company's actions; additional product development steps, including software development; product quality or patient safety issues; and the other factors identified in the company's most recent filing on Form 10-Q and other SEC filings, all of which are available on the company's web site. The company does not undertake to update its forward-looking statements.
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