0001193125-12-286883.txt : 20120628 0001193125-12-286883.hdr.sgml : 20120628 20120628103622 ACCESSION NUMBER: 0001193125-12-286883 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20120628 FILED AS OF DATE: 20120628 DATE AS OF CHANGE: 20120628 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Fresenius Medical Care AG & Co. KGaA CENTRAL INDEX KEY: 0001333141 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-MISC HEALTH & ALLIED SERVICES, NEC [8090] IRS NUMBER: 000000000 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32749 FILM NUMBER: 12931246 BUSINESS ADDRESS: STREET 1: ELSE-KROENER STRASSE 1 CITY: BAD HOMBURG STATE: 2M ZIP: 61352 BUSINESS PHONE: 011-49-6172-6090 MAIL ADDRESS: STREET 1: ELSE-KROENER STRASSE 1 CITY: BAD HOMBURG STATE: 2M ZIP: 61352 6-K 1 d374508d6k.htm FORM 6-K Form 6-K

 

 

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

Pursuant to Rule 13a-16 or 15d-16 of the

Securities Exchange Act of 1934

For the month of June 2012

FRESENIUS MEDICAL CARE AG & Co. KGaA

(Translation of registrant's name into English)

Else-Kröner Strasse 1

61346 Bad Homburg

Germany

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F  þ             Form 40-F  ¨

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):             

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):             

Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes  ¨                        No  þ

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82

 

 

 


On June 27, 2012 Fresenius Medical Care AG & Co. KGaA (the “Company”) issued an Investor News announcing that the Food and Drug Administration (FDA) has classified FMCNA’s voluntary action to change the labeling on its dialysate products as a Class 1 recall.

EXHIBITS

 

Exhibit 99.1    Investor News Release issued June 27, 2012.


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 thereunto duly authorized.

DATE: June 28, 2012

 

FRESENIUS MEDICAL CARE AG & Co. KGaA,

a partnership limited by shares, represented by:

 

FRESENIUS MEDICAL CARE MANAGEMENT AG,

its general partner

By:   /S/ DR. BEN J. LIPPS
Name:       Dr. Ben J. Lipps
Title:       Chief Executive Officer and
 

    Chairman of the Management Board of the

    General Partner

 

By:   /S/ MICHAEL BROSNAN
Name:       Michael Brosnan
Title:       Chief Financial Officer and
 

    Member of the Management Board of the

    General Partner

EX-99.1 2 d374508dex991.htm EXHIBIT 99.1 Exhibit 99.1

Exhibit 99.1

 

LOGO

 

Investor News

  

Oliver Maier

Head of Investor Relations

 

Fresenius Medical Care

Else-Kröner-Straße 1

61352 Bad Homburg

Germany

T +49 6172 609-2601

F +49 6172 609-2301

oliver.maier@fmc-ag.com

www.fmc-ag.com

  
  
  
  
  
  
  
  
  

June 27, 2012

Update on Fresenius Medical Care Dialysate Labeling

Fresenius Medical Care North America (FMCNA) announced today that the Food and Drug Administration (FDA) has classified FMCNA’s voluntary action to change the labeling on its dialysate products as a Class 1 recall.

In conjunction with this classification, and to further reinforce the importance of correct dialysate dosing, FMCNA will continue its process to place updated labels on its NaturaLyte®and GranuFlo®Acid Concentrate products, and to update its hemodialysis machine operator’s manuals. To date, FMCNA has notified more than 90 percent of its customers of these two labeling updates, and will continue with that effort until it is complete.

The FDA’s action does not involve the removal of any FMCNA products from the marketplace.

###

Fresenius Medical Care is the world’s largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure, a condition that affects more than 2.1 million individuals worldwide. Through its network of 3,119 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 253,041 patients around the globe. Fresenius Medical Care is also the world’s leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products.

For more information about Fresenius Medical Care, visit the company’s website at www.fmc-ag.com.

Disclaimer

This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA’s reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.

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