The CDC’s National Institute for Occupational Safety and Health revoked the masks’ emergency use approvals because the company, based in Shanghai, China, didn’t implement, maintain and control a quality management system, the FDA said in a news release.
The FDA said it is “assessing the extent of the concerns and is working with NIOSH to understand and address the issue.”
The agency recommended healthcare facilities replace any Shanghai Dasheng masks with NIOSH-approved ones and said to contact group purchasing organizations, distributors and state and regional resources if they have trouble finding NIOSH-approved masks through their existing vendors.
Read the full news release here.
