agency news release.On Aug. 25, the FDA issued an alert to health care facility risk managers, procurement staff and health care personnel to stop using N95 respirators manufactured by Shanghai Dasheng Health Products Manufacturing Co., Ltd. "The Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) revoked all respirator approvals previously issued to Shanghai Dasheng because the company did not implement, maintain, and control a quality management system," the FDA said.
The following N95 respirators may still have an approval label from the NIOSH but are no longer authorized for emergency use by the FDA: TC-84A-4329, TC-84A-4330, TC-84A-4331, TC-84A-4332, TC-84A-4334, TC-84A-4335,.