Defective KN95 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/or using fraudulent and/or unauthorized KN95 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/kT2r30qHjnE

Direct link: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/73137a-eng.php

Additional information:
Health Canada/Santé Canada (“HCSC”) reports the following Facepiece Respirators are subject to this recall (in alphabetical order, by manufacturer):

  • Baishidun FFP2 Mask made by Anhui Baishidun Protective Equipment Co., Ltd.;
  • Unbranded Mask made by Anhui Jinling Plastics Co., Ltd.
  • 9501 Protective Mask made by Anhui Kangweijia Labor Protection Articles Co., Ltd.
  • KN95B Mask made by Anhui RYZUR Medical Equipment Manufacturing Co., Ltd.
  • SU KN95 Mask made by An Hui Su Bo Lun Clothing Co., Ltd.
  • KN95 Stereo Protective Mask made by Changning Lingjiakang Protective Products Factory
  • KN95 (8410) Mask made by CTT Co., Ltd.
  • KN95 4-PLY Mask made by Daddybaby Co., Ltd.
  • CA 38.504 Mask made by Delta Plus
  • KN95 Disposable Face Mask made by Dongguan Mau Gee Industrial Ltd.
  • Self-Priming Filter Respirator Mask made by Dongguan Oukangda Medical Technology Co., Ltd.
  • Kangerda KN95 Particulate Respirator Mask made by Dongguan Oukangda Medical Technology Co., Ltd.
  • KN95 Protective Mask made by Dongguan Xianda Medical Equipment Co., Ltd.
  • FL 0616 Mask made by Flyhorse Industrial Co., Ltd.
  • Respirator Mask With TruTone Technology Mask made by Garry Galaxy Biotechnology Co., Ltd.
  • Purvigor KN95 Mask made by Guangdong Fei Fan Mstar Technology LTD
  • Efficient Nursing Protective Mask made by Guangdong Nafei Industrial Holding Co., Ltd.
  • NAFY Protective Mask made by Guangdong Nafei Industrial Holding Co., Ltd.
  • KN95-Certified Particulate Respirator Mask made by Guangdong Nuokang Medical Technology Co., Ltd.
  • DNW Protective Mask made by Guangdong Qian Jing Testing Co., LTD.
  • KN95 Mask made by Guangdong Shantou Machinery
  • KN95 Three-Dimensional Protective Respirator Mask made by Guangdong Zhizhen Biological Medicine Co., Ltd.
  • GF-Mask KN95 Mask made by Guangzhou Huashan Biotechnology Co., Ltd.
  • KN95 Mask made by Guangzhou Kangbang Medical Equipment Co., Ltd.
  • K1 Self Suction Filter Respirator Mask made by Guangzhou Sunjoy Auto Supplies Co., Ltd.
  • KN95 Disposable Protective Mask made by Guangzhou Tianyi Zhongliang Biotechnology Group Co., Ltd.
  • KN95 Protective Face Mask made by Guanyang Yuhan Textile Co., Ltd.
  • KN95 Mask-C Mask made by Hangzhou Senrunqing Technology Co., Ltd.
  • KN95 Protective Mask – KS16 Mask made by Henan Kang Medical Devices Co., Ltd.
  • 9501 Mask made by Huabai
  • HV-N 9501B (Non-Sterile Mask) made by Huizhou Huinuo Technology Co., Ltd.
  • HV-N White KN95 Mask made by Huizhou Huinuo Technology Co., Ltd.
  • Anysound KN95 Self-Priming Filter & Anti-Particle Respirator Mask made by Huizhou Zhongna Medical Technology Co., Ltd
  • HC-NP95A Self-Priming Filter Mask made by Jiangsu Homcan Medical Technology Co., Ltd.
  • JT-KN95 Reusable and Sterilizable Nano-mask KN95 Mask made by Jiangsu Jiton Clothing Corporation
  • Protective Mask KN95 Mask made by Jiangsu Newborn Medical Technology Co., Ltd.
  • KN95 Face Mask (Non-Medical) Mask made by Jinhua Jiadaifu Medical Supplies Co., Ltd.
  • PM2.5 KN95 Mask made by Jining Jianda Medical Device Technology Co., Ltd.
  • Y-9500 Mask made by Kindly Care Products Co., Ltd.
  • Y-9500 Mask made by Kindly Care Products Co., Ltd.
  • Self-Breathing Filtration Particle-Preventive Respirator Mask made by King Year and Packaging Co., Ltd.
  • Geyou KN95 Environmental Protective Respirator Mask made by Kuangye (Dongguan) Technology Co., Ltd.
  • SD-KN95 Mask made by Lamdown
  • SD-KN95 Mask made by Lanshan Shendun Technology Co., Ltd.
  • Wanning Protective Mask made by LitezAll
  • KN95 Face Mask made by Nantong Gold-Sufang Weaving Co. Ltd.
  • KN95 Protective Mask made by Ningbo Green Health Science & Technology Co., Ltd.
  • Disposable Protective Mask (Non-Medical) made by Ningbo Green Health Science & Technology Co., Ltd.
  • KN95 (Non-medical) Mask made by Ningbo YiXin Intelligentized Science and Technology Co. Ltd.
  • KN95 Antibacterial Mask made by Purvigor
  • JS95-01 Mask made by San Jiao
  • KN95 Non-Powered Air-Purifying Particulate Respirator Mask made by Senke Pharmaceutical (Chengdu) Co., Ltd.
  • Alchemy KN95 Face Mask A1 Mask made by Shenzhen Hangsen Star Technology Co., Ltd.
  • KN95 Protective Mask made by Shenzhen Meili Medical Devices Co., Ltd.
  • Face Mask KN95 Mask made by Sinpup Health (Shenzhen) Co., Ltd.
  • Wanhuizhong Anti-Dust Respirator Mask made by Tongcheng Chengfeng Protective Equipment Co., Ltd.
  • KN95 Respirator Mask made by Zhejiang Kanghao Medical Instruments Co., Ltd.
  • N95 Masks + Particulate Protection Respirator Mask made by Zhongshan Cassiey Biotechnology Co., Ltd.
  • Protective Mask made by Zhongshan Zhongxin Medical Technology Co., Ltd.

==> No barcodes, UPCs, item numbers 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, it 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.

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 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-73137
Recalls Direct RIN: 13040-2020
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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