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.
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
For further information: Media Enquiries: Health Canada, (613) 957-2983; Public Enquiries: (613) 957-2991, 1-866 225-0709