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CAH > SEC Filings for CAH > Form 8-K on 12-Mar-2009All Recent SEC Filings

Show all filings for CARDINAL HEALTH INC | Request a Trial to NEW EDGAR Online Pro

Form 8-K for CARDINAL HEALTH INC


12-Mar-2009

Other Events


Item 8.01 Other Events

Cardinal Health, Inc. (the "Company") has identified a potential risk with the Alaris PCA (Patient Controlled Analgesia) module when used with the Alaris PC Unit operating with software versions 8 through 9.1. When the products are used together, the Alaris PCA module may infuse above or below the intended infusion dose if a specific sequence of events occurs. The Company has placed a hold on shipping the Alaris PCA module and related Alaris PC Unit until the software is corrected. The Company is in the process of issuing a safety alert to notify customers of the potential risk and providing instructions to help mitigate the risk, along with developing a software correction. Because the Company is operating under a previously disclosed Amended Consent Decree for Condemnation and Permanent Injunction (the "Amended Consent Decree"), it expects to implement this software correction under the corrective action plan required to be submitted to the U.S. Food and Drug Administration no later than April 24, 2009 pursuant to the Amended Consent Decree. The Amended Consent Decree was entered by the U.S. District Court for the Southern District of California on February 23, 2009.

The Company will record a reserve of $6 million in the third quarter of fiscal 2009 related to the estimated cost of developing the software correction and implementing this correction to the existing units currently in use by customers. The Company also currently expects a negative impact on segment profit for its clinical and medical products segment of approximately $14 million during the remainder of fiscal 2009 as a result of the ship-hold, and is taking steps to mitigate this financial impact through cost controls.

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