Fraudulent N95 Respirator Mask Warning [Canada]


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Canada/Ottawa: Logo - Health CanadaHealth Canada, an Ottawa, Ontario regulatory and safety authority, warns Canadians against buying and using fraudulent and/or unauthorized N95 Respirator Masks that may be in the Canadian marketplace due to suspected failure to protect wearers against the SARS-CoV-2 virus and consequential risk of COVID-19 (also known as “Coronavirus”) infection as well as consequential heart, lung and kidney damage, all serious health and safety hazards.

HCSC: http://ht.ly/OmKe30qzrI6

Direct link: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/72707a-eng.php

Additional information:
Health Canada/Santé Canada (“HCSC”) reports that it has received reports that fraudulent and/or non-certified N95 Respirator Masks that falsely claim to protect users against COVID-19 are being illegally sold to consumers online and in some stores.

In Canada, N95 Class Respirators are regulated by Health Canada as Class I Medical Devices and are manufactured or imported by companies that hold a Medical Device Establishment Licence. They are also certified by the US National Institute for Occupational Safety and Health (“NIOSH”).

==> No specific barcodes, UPCs, item numbers or other identification numbers were listed with this warning notification.

According to Health Canada, fraudulent or unauthorized N95 Respirator Masks may not meet the same performance specifications required by the NIOSH N95 standard and, as a result, may not properly protect wearers from SARS-CoV-2, the viral agent that causes COVID-19 (also known as “Coronavirus”).

When worn properly, NIOSH-certified N95 Respirator Masks are designed to secure a close facial fit and reduce the risk of inhaling hazardous airborne particles and aerosols. The “N95” designation means that when subjected to careful testing, the respirator blocks at least 95% of very small test particles, such as pathogens.

Please note: it is illegal to sell or advertise health products that make false or misleading claims. Health Canada says it takes this issue seriously and will use all available tools to stop these activities. The organization monitors Web sites and takes action when false claims and/or unauthorized products are identified, and is working with online retailers to ensure that these products are removed from their Web sites.

Please consult Health Canada’s Web site for buying and using drug and health products safely here: https://www.canada.ca/en/health-canada/topics/buying-using-drug-health-products-safely.html.

Please check whether your N95 Respirator Masks have been certified by the US National Institute for Occupational Safety and Health (“NIOSH”). If your Mask is fraudulent or unauthorized, kindly stop using it as it may not protect you against COVID-19. You can check that your N95 Respirator Mask has been certified by NIOSH by entering its approval number – a number specific to each type and manufacturer of Mask – that can be found on the respirator itself, into the NIOSH database at https://wwwn.cdc.gov/niosh-cel/.

Carefully review the product package and Respirator Mask itself to ensure it has the appropriate markings and details, as required by NIOSH. This includes the TC (Testing and Certification) approval number (a number set by NIOSH), the name of the manufacturer, the NIOSH name or logo, the model number, and filter efficiency (in this case, “N95”).

Carefully inspect the product markings, such as the name of the manufacturer, to determine whether there are any obvious signs that the product is counterfeit (e.g., incorrect spelling, blurred writing, odd smells or flimsy construction). Keep in mind, counterfeiters can print a real NIOSH designation number on a fake mask: ensure both the designation number and the manufacturer match. In addition, purchasing your Respirator Mask products from authorized or trusted sources may help reduce the chances of receiving counterfeit medical supplies and/or equipment.

If your Mask is fraudulent or not certified, stop using it as it is both dangerous to you and feeds additional illegal activities.

You can report information on the potential false or misleading advertising or sale of unauthorized medical products to Health Canada here: https://health.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/health-product-complaint-form-0317.html.

For the latest and most up-to-date information on COVID-19 visit https://www.canada.ca/en/public-health/services/diseases/coronavirus-disease-covid-19.html

If you have any further questions, comments or complaints about this recall, please contact Health Canada toll-free at 1-833-784-4397 (or 1-613-957-2991 for local/international callers) during normal business hours Eastern Standard Time, Monday to Friday.

Please note: the Canada Consumer Product Safety Act prohibits recalled or counterfeit products from being redistributed, sold or even given away in Canada.

==> To see other recalls and notifications caused by suspected faulty and/or dangerous N95 Respirator Masks, please search for “mask” or more generically, “medical equipment” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Bacterial hazard, please search for “bacterial” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Viral hazard, please search for “virus” using the Search Box at the top of this page.

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More information about this recall:
HCSC ID number: RA-72707
Recalls Direct RIN: 12940-2020
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food product you purchased in Canada [external: new window opens]:
==> http://www.inspection.gc.ca/food/information-for-consumers/report-a-concern/eng/1364500149016/1364500195684
Search for a recalled food on the Health Canada Web site [external: new window opens]:
==> http://healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php

We welcome your feedback:
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E. & O. E.

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