Global KN95 Respirator Mask Recall [Canada]


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Canada/Ottawa: Logo - Health CanadaCTG Brands Inc., a Vaughan, Ontario establishment, recalls certain batch/lots of Global branded KN95 Face Masks from 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/LzuA30qNmba

Direct link: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/73255r-eng.php

Additional information:
Health Canada/Santé Canada (“HCSC”) reports the following Facepiece Respirators are subject to this recall:

  • Global branded KN95 Face Masks, sold with a model number of 74872
  • Global branded KN95 Face Masks, sold with a model number of 74872-AC

==> No barcodes, UPCs, item numbers, best-before date codes, manufacturing date codes, production dates, expiry dates, registration numbers, agency approval designations or other identification numbers were listed with this recall notification.

In Canada, N95 and KN95 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”).

According to Health Canada, the US National Personal Protective Technology Laboratory (“NPPTL”) has tested a representative sample of these Masks and has determined that the KN95 Filtering Facepiece Respirators (“respirators”) listed above have failed to demonstrate the required 95% filtration rate and are possibly being imported into Canada, posing a health and safety risk to wearers.

==> You can see the results of this testing at the NPPTL Web site here: https://www.cdc.gov/niosh/npptl/respirators/testing/nonnioshresults.html.

Based on the testing done by the National Institute of Occupational Safety and Health (“NIOSH”) National Personal Protective Technology Laboratory (“NPPTL”), Health Canada cannot reasonably conclude that the benefits associated with having the identified KN95 Filtering Facepiece Respirators available in Canada, as currently labelled, outweigh the risks.

Consequently, an excessive amount of particles and/or microorganisms might pass through the Mask, increasing the risk of infection if not combined with additional protective measures. A wearer may consequently become ill when the Mask fails to protect him or her against microbial contamination. If used to prevent the spread against SARS-CoV-2, the virus that causes COVID-19 (i.e., Coronavirus), this operational failure may lead to pulmonary, cardiac, hepatic and/or nephritic injuries could be life-changing and/or life-threatening.

If you believe you have purchased or have in your possession any of the recalled Respirator Masks, please do not use them. Instead, kindly return the product to the store where you purchased it for a full refund.

Learn more about KN95 masks and respirators that are approved under standards used in other countries that are similar to NIOSH-approved N95 respirators by visiting the following Health Canada Web site: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/masks-respirators-covid19.html#a5.

Health Canada has also warned about avoiding counterfeit medical supplies being imported into Canada during the Coronavirus/Covid-19 Pandemic. 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 and/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, please 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 or KN95 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-73255
Recalls Direct RIN: 13105-2020
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

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E. & O. E.

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