Baxter Healthcare Corporation Announces Plans To Voluntarily Withdraw 6060 Multi-Therapy Infusion Pump
DEERFIELD, Ill., Nov. 15 /PRNewswire-FirstCall/ -- Baxter Healthcare Corporation announced today in a field corrective action letter to customers that it plans to voluntarily withdraw its 6060 Multi-Therapy Infusion Pump from the marketplace over the next 12 months. During this time, Baxter will continue to manufacture and sell disposable sets and support customers with service maintenance as they transition to alternate pumps. This ambulatory infusion pump delivers intravenous medications to patients mainly in alternate care settings or at home. The 6060 infusion pump was developed by Sabratek and acquired by Baxter in 2000, and approximately 34,000 pumps are currently in use worldwide, including 30,000 in the United States. Anticipated worldwide sales for 2005 of the 6060 pump and related disposable sets are approximately $15 million.
Baxter's letter to customers informed them of potential issues when the 6060 infusion pump is used to deliver pain management medications in the Patient Controlled Analgesia (PCA) profile, as well as in administering critical medications. While the probability of occurrence of these issues is remote, Baxter is warning against the use of the pump in the PCA profile. In addition, the company has recommended that an alternative device be used when an interruption of critical therapy could cause immediate harm.
"Because the 6060 design is at the end of its life cycle, we've made the decision to discontinue this infusion pump and focus our resources on providing products with the latest technology that better meet the needs of our customers and their patients," said Peter Arduini, president of Baxter's Medication Delivery business. "This decision reflects the evaluation of the costs required to upgrade this technology and the development timeline, and is an example of new disciplines resulting from improvements in our quality processes."
Baxter has communicated its decision to the U.S. Food and Drug Administration (FDA), and the company will be working with customers on a transition plan. The company expects to take an after-tax charge of approximately $45 million (or $0.07 per diluted share) in the fourth quarter of 2005 associated with this product withdrawal, 60 percent of which will be cash.
In order to ensure an orderly transition to alternate pumps, Baxter signed a non-exclusive distribution agreement with Smiths Medical, a global leader in ambulatory infusion therapy. Baxter remains committed to its customers and patients who utilize ambulatory infusion therapy and will distribute Smiths Medical pumps, sets and ancillary products. This will also enable Baxter to continue to focus on sales of parenteral nutritional products, premixed drugs and fluids to the ambulatory care market.
About Baxter
Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. . Baxter assists healthcare professionals and their patients with 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. For more information about Baxter, please visit http://www.baxter.com .
This release includes forward-looking statements concerning the company's 6060 infusion pump, including the intended course of the withdrawal and the related financial charge. 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; product quality or patient safety issues; and other risks identified in the company's most recent filing on Form 10-Q. The company does not undertake to update its forward-looking statements.
Baxter Healthcare CorporationCONTACT: media, Cindy Resman, +1-847-948-2815, or Tom Kline,+1-847-948-2251, or investors, Mary Kay Ladone, +1-847-948-3371, or ClareSullivan, +1-847-948-3085, all of Baxter Healthcare Corporation
Web site: http://www.baxter.com/