8-KRegulation FDOther EventsExhibits & Filings

CARDINAL HEALTH INC 8-K Report, Regulation FD Disclosure (Jul 10, 2009)

Filed July 10, 2009For Securities:CAH

Summary

This 8-K filing from Cardinal Health, Inc. (CAH) on July 10, 2009, announces a significant operational development related to its subsidiary, CareFusion Corporation. The key information for investors is the resumption of shipping for Alaris® PC units and Alaris® PCA modules. This resumption is directly tied to the receipt of FDA 510(k) clearance for a software correction that addresses a previously identified risk. The risk involved potential infusion dosage inaccuracies when the Alaris PCA module is used with specific software versions of the Alaris PC Unit under a particular sequence of events. The clearance and subsequent resumption of shipping are positive indicators for CareFusion's business operations and its planned spin-off, which was expected to result in a publicly traded entity. This resolution of a product safety concern and the associated shipping hold is crucial for revenue generation and investor confidence in the upcoming separation.

Key Highlights

  • 1CareFusion Corporation, a subsidiary of Cardinal Health, Inc., will resume shipping Alaris® PC units and Alaris® PCA modules.
  • 2The resumption of shipping is contingent on receiving FDA 510(k) clearance for a software correction.
  • 3The software correction addresses a potential risk of incorrect infusion doses with Alaris PCA modules when used with specific Alaris PC Unit software versions (8 through 9.1) under a defined sequence of events.
  • 4Cardinal Health had previously placed a hold on shipping these products pending the software correction.
  • 5FDA 510(k) clearance for the software correction was received on July 9, 2009.
  • 6This development is positive for CareFusion's operational continuity and its upcoming spin-off.

Frequently Asked Questions

The 8-K filing announces that CareFusion Corporation, a subsidiary of Cardinal Health, Inc., has received FDA clearance and will resume shipping its Alaris® PC units and Alaris® PCA modules.

There was a potential risk identified where the Alaris PCA module, when used with specific versions of the Alaris PC Unit software (versions 8 through 9.1) and under a particular sequence of events, could infuse medication above or below the intended dose.

Cardinal Health received FDA 510(k) clearance for the software correction on July 9, 2009.

This clearance and the resumption of shipping are significant because they resolve a product safety concern and allow CareFusion to continue its sales operations. This is particularly important as CareFusion was expected to become a public company through a planned spin-off from Cardinal Health.