city Shanghai hospital mask Health city Shanghai

Use of certain N95 masks should stop due to ‘serious’ quality concerns, FDA says

Reading now: 537
www.fox29.com

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,.

Read more on fox29.com
The website covid-19.rehab is an aggregator of news from open sources. The source is indicated at the beginning and at the end of the announcement. You can send a complaint on the news if you find it unreliable.

Related News

DMCA