-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, FuuWSqYMw8Nym58x78JzXxBy6Uehkq35/lWXpHkDYLTJb1wjXRT7V3RhRpfUWzmC v9xv4i+oeOU04u30T1YKdw== 0001193125-09-147018.txt : 20090710 0001193125-09-147018.hdr.sgml : 20090710 20090710090445 ACCESSION NUMBER: 0001193125-09-147018 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20090709 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090710 DATE AS OF CHANGE: 20090710 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CARDINAL HEALTH INC CENTRAL INDEX KEY: 0000721371 STANDARD INDUSTRIAL CLASSIFICATION: WHOLESALE-DRUGS PROPRIETARIES & DRUGGISTS' SUNDRIES [5122] IRS NUMBER: 310958666 STATE OF INCORPORATION: OH FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-11373 FILM NUMBER: 09938515 BUSINESS ADDRESS: STREET 1: 7000 CARDINAL PLACE CITY: DUBLIN STATE: OH ZIP: 43017 BUSINESS PHONE: 6147573033 MAIL ADDRESS: STREET 1: 7000 CARDINAL PLACE CITY: DUBLIN STATE: OH ZIP: 43017 FORMER COMPANY: FORMER CONFORMED NAME: CARDINAL DISTRIBUTION INC DATE OF NAME CHANGE: 19920703 8-K 1 d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 9, 2009

 

 

Cardinal Health, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Ohio   1-11373   31-0958666

(State or other jurisdiction

of incorporation)

  (Commission File Number)  

(IRS Employer

Identification No.)

 

7000 Cardinal Place, Dublin, Ohio   43017
(Address of principal executive offices)   (Zip Code)

(614) 757-5000

(Registrant’s telephone number, including area code)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 7.01 Regulation FD Disclosure

On July 10, 2009, CareFusion Corporation (“CareFusion”), the entity that is currently a wholly owned subsidiary of Cardinal Health, Inc. (the “Company”) and that is expected to become public as a result of the planned spin-off of the Company’s clinical and medical products businesses, issued a press release announcing that it will resume shipping Alaris® PC units and Alaris® PCA (Patient Controlled Analgesia) modules. A copy of the news release is included as Exhibit 99.1 to this report.

 

Item 8.01 Other Events

As previously reported, on April 24, 2009, the Company submitted the corrective action plan required by the Amended Consent Decree for Condemnation and Permanent Injunction between a subsidiary of the Company and the U.S. Food and Drug Administration (the “FDA”). Included in the corrective action plan was, among other proposed corrective actions, a software correction that addresses the potential risk recently identified with the Alaris PCA 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 had placed a hold on shipping the Alaris PCA module and related Alaris PC Unit until the software was corrected. On July 9, 2009, the Company received FDA 510(k) clearance for the software correction, which allows the Company to resume shipping the Alaris PC unit and Alaris PCA module. See the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2009 filed on May 7, 2009 and Amendment No. 5 to CareFusion’s Form 10 registration statement filed on July 8, 2009 for additional information on this matter.

 

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

 

99.1    News release issued by CareFusion Corporation on July 10, 2009.

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    Cardinal Health, Inc.
    (Registrant)
Date: July 10, 2009     By:  

/s/ Craig S. Morford

    Name:   Craig S. Morford
    Title:   Chief Legal and Compliance Officer

 

- 3 -


EXHIBIT INDEX

 

99.1    News release issued by CareFusion Corporation on July 10, 2009.

 

- 4 -

EX-99.1 2 dex991.htm NEWS RELEASE News release

Exhibit 99.1

LOGO

3750 Torrey View Ct.

San Diego, CA 92130

www.CareFusion.com

FOR IMMEDIATE RELEASE

Contacts:

 

Media:  

Jim Mazzola

(858) 617-1203

jim.mazzola@carefusion.com

   Investors:   

Carol Cox

(858) 617-2020

carol.cox@carefusion.com

CAREFUSION TO RESUME SHIPPING ALARIS® INFUSION PRODUCTS

SAN DIEGO, July 10, 2009 — CareFusion Corporation, the company that will become public from the planned spinoff of Cardinal Health’s clinical and medical products businesses, today announced it will immediately resume customer implementations of its Alaris® PC units and PCA (Patient Controlled Analgesia) modules following a shipping hold announced in March.

The company is ready to resume shipments following 510(k) clearance from the Food and Drug Administration (FDA) for a software correction that will be implemented on new Alaris PC units.

“The 510(k) clearance for our software correction is another important milestone in our continued progress under the amended consent decree,” said Dwight Winstead, chief operating officer of CareFusion. “We will continue to work closely with the FDA to fulfill all of our obligations under the amended consent decree and execute within our new quality system to manufacture products that are among the safest in the industry.”

The 510(k) clearance follows FDA acceptance of the company’s corrective action plan for field remediation of its infusion pumps that was announced on June 9. For Alaris PC units already with customers, CareFusion will begin implementing the software correction as part of this corrective action plan.

About CareFusion Corporation

CareFusion Corporation, a wholly owned subsidiary of Cardinal Health (NYSE:CAH), is expected to become a public company from the planned spinoff of Cardinal Health’s clinical and medical products businesses. The global company serves the health care industry with products and services that help hospitals measurably improve the safety and quality of health care. CareFusion develops market-

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CareFusion News

Page 2 of 2

leading technologies including Alaris® IV pumps, Pyxis® automated dispensing and patient identification systems, AVEA and Pulmonetic Systems ventilation and respiratory products, ChloraPrep® and MedMined™ services for infection prevention, neurological monitoring and diagnostic products, V. Mueller® surgical instruments, and an extensive line of products that support interventional medicine.

CareFusion employs more than 15,000 people across its global operations and serves customers in 120 countries. The company has applied to have its shares of common stock listed on the New York Stock Exchange under the ticker symbol “CFN.” More information may be found at www.carefusion.com.

Cautions Concerning Forward-Looking Statements

This news release contains forward-looking statements addressing the planned spinoff of Cardinal Health’s clinical and medical products businesses as a separate company named CareFusion Corporation, which is dependent upon future events or developments. These matters are subject to risks and uncertainties that could cause actual events (including the planned spinoff) and results to differ materially from those projected, anticipated or implied. These risks and uncertainties include uncertainties regarding the planned spinoff of CareFusion, including the timing and terms of any such spinoff and whether such spinoff will be completed as it is subject to a number of conditions. In addition, Cardinal Health and CareFusion are subject to additional risks and uncertainties described in CareFusion’s Form 10, as amended, and 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. Except to the extent required by applicable law, Cardinal Health and CareFusion undertake no obligation to update or revise any forward-looking statement.

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-----END PRIVACY-ENHANCED MESSAGE-----