OTTAWA, Sept. 19, 2014 /CNW/ - The issue: Baxter Corporation, in collaboration with Health Canada, is voluntarily recalling specific lots of two Acid Concentrate hemodialysis solutions (see below) due to particulate matter found in the product. Particulate matter in the product may cause inadequate dialysis and may result in serious injury such as allergic reactions or blockage of small blood vessels if it enters into a patient's bloodstream.
The affected products were distributed to hospital and home settings between January 31, 2014 and July 18, 2014. These products are used in home hemodialysis patients. Those who administer these products in home-care settings should check the lot numbers before administration.
Who is affected: Canadians who have used the affected lots of either of these two products. The company has indicated that it has not received reports of any adverse events associated with the particulate matter.
What consumers should do:
- Immediately examine your stock to determine whether you have any of the affected product lots. If any of these are found, speak to your healthcare provider immediately regarding replacement product.
- Contact Baxter Corporation Customer Care at 1-888-719-9955 for instructions on how to return the recalled product.
- Report any adverse events to Health Canada.
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.
These products are 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.
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. Acid Concentrate 45X (45 K, 67.5 Ca) (DIN 02158256) Lot No. W4D17D1
2. Acid Concentrate 45X (45 K, 45.0 Ca) (DIN 00860611) Lot No. W4A24D1
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