DGAP-News: Fresenius Medical Care AG & Co. KGaA / Key word(s):
Miscellaneous
Fresenius Medical Care AG & Co. KGaA: Update on Fresenius Medical Care
Dialysate Labeling
27.06.2012 / 18:51
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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(R) and GranuFlo(R) 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.
End of Corporate News
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27.06.2012 Dissemination of a Corporate News, transmitted by DGAP - a
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Language: English
Company: Fresenius Medical Care AG & Co. KGaA
Else-Kröner-StraÃe 1
61352 Bad Homburg
Germany
Phone: +49 (0) 6172- 609 2525
Fax: +49 (0) 6172- 609 2301
E-mail: ir@fmc-ag.com
Internet: www.fmc-ag.de
ISIN: DE0005785802, DE0005785836,
WKN: 578580, 578583
Indices: DAX
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, Hamburg, Hannover,
München, Stuttgart; Terminbörse EUREX; NYSE
End of News DGAP News-Service
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175710 27.06.2012
DGAP-News: Fresenius Medical Care AG & Co. KGaA: Update on Fresenius Medical Care Dialysate Labeling
| Source: EQS Group AG