Fresenius Medical Care North America (FMCNA) announced today that its
voluntary recall of 56 lots of NaturaLyte® Liquid Bicarbonate
Concentrate, 6.4 liters (intended for use in hemodialysis machines) from
distribution has been classified as a Class 1 Recall.
The affected lots were produced in its Montreal, Canada facility and are
being recalled because they may develop higher bacteria levels than is
allowed by the company’s internal specification during their shelf life.
Laboratory testing has identified the bacteria as Halomonas (species 1,
2, 3), a Gram Negative bacteria, typically found in water with high
salinity (salt concentration). According to a few case reports in the
medical literature, bacterial contamination of the dialysate may lead to
bacteremia or systemic infection. The dialysis filter (dialyzer) and the
use of the Diasafe™ filter or equivalent create an effective bacteria
and endotoxin barrier that makes this event unlikely.
Customer notifications were published on April 10th and May 1st,
2014. The customer notifications (available at www.fmcna.com)
include a list of the product lot numbers which should be permanently
removed from use and returned.
As part of its voluntary recall, the company informed the U.S. Food and
Drug Administration (FDA) and Health Canada, as well as its customers -
on April 10th and May 1st, 2014 - about these
findings and promptly took steps to remove all of the affected lots from
distribution, and discontinue their use.
Customers are encouraged to contact the FDA through the following means
if they experience adverse reactions or quality problems from using this
product:
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Accessing the MedWatch website at www.fda.gov/medwatch
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Calling 1-800-FDA-1088
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Faxing at 1-800-FDA-0178, or by
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Mailing to: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD
20852-9787
Customers can contact Fresenius Medical Care’s customer service teams at
1-800-323-5188 to report these issues, or if they have additional
questions.
About Fresenius Medical Care North America
Through its leading network of more than 2,150 dialysis facilities in
North America and vascular access centers, laboratory, pharmacy and
affiliated hospitals and nephrology practices, Fresenius Medical Care
provides renal services to hundreds of thousands of people throughout
the United States, Mexico and Canada. It is also the continent's top
producer of dialysis equipment, dialyzers and related disposable
products and a major supplier of renal pharmaceuticals. For more
information about the company, visit www.fmcna.com;
for information about patient services, visit www.ultracare-dialysis.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.
Copyright Business Wire 2014