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 FMCNAs 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 |
Exhibit 99.1
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 FMCNAs 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 operators 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 FDAs action does not involve the removal of any FMCNA products from the marketplace.
###
Fresenius Medical Care is the worlds 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 worlds leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products.
For more information about Fresenius Medical Care, visit the companys 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. KGaAs 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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