DUBLIN, Ohio, Feb. 6 /PRNewswire-FirstCall/ - Cardinal Health, the leading provider of products and services supporting the health-care industry, today announced it has reached an agreement with the Food and Drug Administration (FDA) on a consent decree regarding its Alaris® SE line of infusion pumps.
The agreement, which is subject to approval by the U.S. District Court for the Southern District of California, outlines the process Cardinal Health will follow to resume the manufacture and sale of its Alaris® SE pumps (formerly the Signature Edition® Infusion System) in the U.S. market. Steps include submitting a plan to the FDA outlining corrections for the Alaris® SE pumps currently in use by customers, submitting a remediation plan for the seized Alaris® SE pumps, and engaging an independent expert to inspect Alaris® SE pump facilities and certify Cardinal Health’s infusion pump operations. The corrective action and remediation plans must be approved by the FDA prior to implementation by Cardinal Health.
“We have worked very closely with the FDA since initiating a voluntary field corrective action for the product last year, and are pleased to have now reached this agreement outlining the steps we’ll take to resume manufacturing and sale of the Alaris® SE pumps,” said Dave Schlotterbeck, chief executive officer of Pharmaceutical and Medical Products for Cardinal Health.
On Aug. 15, 2006, Cardinal Health initiated a voluntary field corrective action of the product as the result of information indicating that a sensitive keypad posed a risk of ‘key bounce’ that could lead to the over-infusing of patients. As part of the field corrective action, Cardinal Health sent letters and warning labels to its customers. On Aug. 28, 2006, Cardinal Health suspended production, sales and repairs of its Alaris® SE infusion pump after approximately 1,300 units were seized by the FDA. These actions did not require the return of products currently in use by customers. Servicing of Alaris® SE pumps was previously resumed on Sept. 15, 2006 with agreement from the FDA.
There have been approximately 140,000 Alaris® SE infusion pumps distributed worldwide during the past 12 years and the product line currently represents less than 1 percent of annual revenue for Cardinal Health’s Clinical Technologies and Services segment. As previously disclosed, the company reserved $13.5 million in the first quarter of fiscal year 2007 for the estimated costs to implement a corrective action plan.
Customers with questions regarding this product can contact Cardinal Health at (877) 552-4922. Other related questions or reports may be addressed to Customer Advocacy at (800) 854-7128, extension 7812 or via e-mail at customerfeedback@cardinal.com.
The full agreement will be posted to the Cardinal Health web site at www.cardinalhealth.com upon approval by the U.S. District Court.
About Cardinal Health
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH - News) is an $81 billion, global company serving the health-care industry with a broad portfolio of products and services. Through its diverse offerings, Cardinal Health delivers health-care solutions that help customers reduce their costs, improve safety and productivity, and deliver better care to patients. The company manufactures, packages and distributes pharmaceuticals and medical supplies, offers a range of clinical services and develops automation products that improve the management and delivery of supplies and medication for hospitals, physician offices and pharmacies. Ranked No. 19 on the Fortune 500, Cardinal Health employs more than 55,000 people on six continents. More information about the company may be found at www.cardinalhealth.com.
Except for historical information, all other information in this news release consists of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These forward- looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied. The most significant of these uncertainties are described in Cardinal Health’s Form 10-K, Form 10-Q and Form 8-K reports (including all amendments to those reports) and exhibits to those reports, and include (but are not limited to) the following: competitive pressures in its various lines of business; the loss of one or more key customer or supplier relationships or changes to the terms of those relationships; changes in the distribution patterns or reimbursement rates for health-care products and/or services; the results, consequences, effects or timing of any inquiry or investigation by or settlement discussions with any regulatory authority or any legal and administrative proceedings, including shareholder litigation; uncertainties related to completing the divestiture of the PTS segment, including the fulfillment or waiver of conditions to closing under the acquisition agreement and any adjustments as to the amount of actual proceeds to be received; the costs, difficulties and uncertainties related to the integration of acquired businesses; and general economic and market conditions. Except to the extent required by applicable law, Cardinal Health undertakes no obligation to update or revise any forward-looking statement.
Source: Cardinal Health, Inc.
