FDA Warns Health Care Providers Not to Use Some Shanghai Dasheng N95 Masks

August 30, 2021

The FDA issued an alert for healthcare professionals to stop using certain N95 respirators made by Chinese company Shanghai Dasheng Health Products Manufacturing for which the agency has revoked its emergency use authorization.

The National Institute for Occupational Safety and Health (NIOSH) cancelled all respirator approvals previously issued to Shanghai Dasheng “because the company did not implement, maintain, and control a quality management system,” the FDA said.

“All previously authorized Shanghai Dasheng respirators are no longer authorized for emergency use as a result of the loss of NIOSH-approval,” the agency said.

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