June 8, 2020
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As part of its efforts to equip Canada to fight Covid-19, Health Canada’s Interim Order dated March 18, 2020 expedited the review and approval of Medical Device Establishment Licences for Class I devices, including so-called N95 masks. Since that time, the masks of many manufacturers have been imported into Canada.
On May 11, 2020, Health Canada was forced to issue a recall of KN95 Filtering Facepiece Respirators imported from certain listed manufacturers in China. This recall notice made it the responsibility of all MDEL and Submission Number holders who import KN95 respirators from the listed companies to self-identify and cease selling these items as KN95 masks. However, the importers may continue to sell the item as face masks, rather than respirators, for use where 95% filtration is not needed.
On May 19, 2020, Health Canada expanded the list of manufacturers whose KN95 masks are to be recalled to include:
Anhui Baishidun Protective Equipment Co., Ltd., Anhui Jinling Plastics Co., Ltd., Anhui Kangweijia Labor Protection Articles Co., Ltd., Anhui RYZUR Medical Equipment Manufacturing Co., Ltd., An Hui Su Bo Lun Clothing Co., Ltd., Changning Lingjiakang Protective Products Factory, CTT Co., Ltd., Daddybaby Co., Ltd., Delta Plus, Dongguan Mau Gee Industrial Ltd., Dongguan Oukangda Medical Technology Co., Ltd., Dongguan Oukangda Medical Technology Co., Ltd., Dongguan Xianda Medical Equipment Co., Ltd., Flyhorse Industrial Co., Ltd., Garry Galaxy Biotechnology Co., Ltd., Guangdong Fei Fan Mstar Technology LTD, Guangdong Nafei Industrial Holding Co., Ltd., Guangdong Nafei Industrial Holding Co., Ltd., Guangdong Nuokang Medical Technology Co., Ltd., Guangdong Qian Jing Testing Co., LTD., Guangdong Shantou Machinery, Guangdong Zhizhen Biological Medicine Co., Ltd., Guangzhou Huashan Biotechnology Co., Ltd., Guangzhou Kangbang Medical Equipment Co., Ltd., Guangzhou Sunjoy Auto Supplies Co., Ltd., Guangzhou Tianyi Zhongliang Biotechnology Group Co., Ltd., Guanyang Yuhan Textile Co., Ltd., Hangzhou Senrunqing Technology Co., Ltd., Henan Kang Medical Devices Co., Ltd., Huabai Huizhou Huinuo Technology Co., Ltd., Huizhou Huinuo Technology Co., Ltd., Huizhou Zhongna Medical Technology Co., Ltd., Jiangsu Homcan Medical Technology Co., Ltd., Jiangsu Jiton Clothing Corporation, Jiangsu Newborn Medical Technology Co., Ltd., Jinhua Jiadaifu Medical Supplies Co., Ltd., Jining Jianda Medical Device Technology Co., Ltd., Kindly Care Products Co., Ltd., Kindly Care Products Co., Ltd., King Year and Packaging Co., Ltd., King Year and Packaging Co., Ltd., Kuangye (Dongguan) Technology Co., Ltd., Lamdown Lanshan Shendun Technology Co., Ltd., LitezAll Nantong Gold-Sufang Weaving Co. Ltd., Ningbo Green Health Science & Technology Co., Ltd., Ningbo Green Health Science & Technology Co., Ltd., Ningbo YiXin Intelligentized Science and Technology Co. Ltd., Purvigor San Jiao, Senke Pharmaceutical (Chengdu) Co., Ltd., Shenzhen Hangsen Star Technology Co., Ltd., Shenzhen Meili Medical Devices Co., Ltd., Sinpup Health (Shenzhen) Co., Ltd., Tongcheng Chengfeng Protective Equipment Co., Ltd., Zhejiang Kanghao Medical Instruments Co., Ltd., Zhongshan Cassiey Biotechnology Co., Ltd., Zhongshan Zhongxin Medical Technology Co., Ltd.
Author: Richard Naiberg