Advisory - Voluntary recall: NaturaLyte Sodium Bicarbonate Liquid Concentrate

Advisory - Voluntary recall: NaturaLyte Sodium Bicarbonate Liquid Concentrate 
OTTAWA, April 5, 2014 /CNW/ - The issue: Health Canada has been informed that 
Fresenius Medical Care is voluntarily recalling specific lots of "NaturaLyte 
Sodium Bicarbonate Liquid Concentrate" in 6.4L and 8L volumes due to bacterial 
This product is used as a form of dialysis (hemodialysis) that removes waste 
products from the blood by passing them out of the body through a filtering 
system and returning them, cleaned, to the body. The affected product was 
distributed to hospital and home settings between August 8, 2013 and October 
28, 2013.  Home care nurses and other all other users should check lots (see 
below) before administering it. 
Who is affected: Canadians who have used this product. The company has 
indicated that it has not received reports of any adverse events associated 
with the possible bacterial contamination. 
What consumers should do: 

    --  Do not use affected lots.
    --  Use only NaturaLyte Sodium Bicarbonate Liquid Concentrate from
        lots not affected by the recall, or an alternative product.
    --  If alternatives are not available, then please follow the
        advice of your healthcare professional regarding your dialysis
    --  Report any adverse events to
        Health Canada.

What hospitals and home patient programs should do:
    --  Immediately examine your stock to determine whether you have
        any of the affected product lots.
    --  If any of these are found, discontinue use immediately.
    --  Place all units in a secure, segregated area.
    --  Contact the Fresenius Customer Service Team at 1-888-709-4411
        for instructions on how to return the recalled product.

What Health Canada is doing:

Health Canada is monitoring the recall and working with the company to help 
ensure patients and healthcare professionals are informed. Health Canada will 
provide an update to Canadians, as necessary.

For more information:

Consumers and health professionals wanting more information about this 
advisory from Health Canada can contact the Public Enquiries Line at 
613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada 
Media Relations at 613-957-2983.

Products affected: 1. NaturaLyte Sodium Bicarbonate Liquid Concentrate (Lots: 
13JMLB004, 13JMLB006, 13JMLB007 and 13JMLB008 in 6.4L and 8L volumes)

How to report side effects of health products to Health Canada:
    --  Call toll-free at 1-866-234-2345
    --  Visit MedEffect Canada's web page on
        Adverse Reaction Reporting
        for information on how to report online, by mail or by fax.

Stay connected with Health Canada and receive the latest advisories and 
product recalls using social media tools.

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SOURCE  Health Canada 
Media Enquiries: Health Canada, (613) 957-2983; Public Enquiries: (613) 
957-2991, 1-866 225-0709 
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CO: Government of Canada
ST: Ontario
-0- Apr/05/2014 17:58 GMT
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