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  contamination.  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         treatment.     --  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.  Également disponible en français    SOURCE  Health Canada  Media Enquiries: Health Canada, (613) 957-2983; Public Enquiries: (613)  957-2991, 1-866 225-0709  To view this news release in HTML formatting, please use the following URL:  CO: Government of Canada ST: Ontario NI: HEA  
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