Health Canada has determined that KN95 respirators manufactured by 16 companies do not meet the required standards for filtration or the design features related to achieving an adequate fit:
- Anhui Subolun Garment Co Ltd
- Bengbu Hongjie Medical Equipment Co Ltd
- Donnaturel; Wanwei Chuangda Medical Technology (Shandong) Co Ltd
- Guangzhou Folunsi Industrial Co Ltd
- Hangzhou Unibear Medical Devices Co Ltd
- KMP
- Luoyang Haoyang Clothing Ltd
- Ningbo Kangqi Medical Supplies Co Ltd
- Qingdao Caiyan Childrens Articles Co Ltd
- Qingdao Hongshunyi Project Co Ltd
- Quzhou Benneng Vehicle Co Ltd
- Sichuan Fogu Medical Technology Co Ltd
- Tianjin Benmo Medical Equipment Co Ltd
- Wonder Medical Technology Co Ltd (Donnaturel)
- Yiwu Wells Knitting Co Ltd
- Zhejiang Beilan Protective Equipment Co Ltd
KN95s manufactured by these companies may pose a health and safety risk in settings where a 95% filtration is required, Health Canada said. These products must be relabeled as face masks for use in settings where 95% filtration is not required. Under the Medical Devices Regulations, this relabeling is considered a recall.
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