Voluntary Nationwide and Canada Recall of NaturaLyte® Liquid Bicarbonate Concentrate Due to Potential Health Risk
May 21 2014 - 5:00PM
Business Wire
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:
- Accessing the MedWatch website at
www.fda.gov/medwatch
- Calling 1-800-FDA-1088
- Faxing at 1-800-FDA-0178, or by
- 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.
Media contact:Fresenius Medical CareJon Stone, 781-699-9704
(o)/781-392-4680 (cell)Jonathan.d.stone@fmc-na.com
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