FDA: some N95 masks revoked for quality issues

Face masks are stacked before they get technical information printed on them at a new factory in Mexico City on Thursday, May 21, 2020.

Face masks are stacked before they get technical information printed on them at a new factory in Mexico City on Thursday, May 21, 2020.


Federal health officials are warning medical professionals of “serious concerns” about the quality of some N95 masks manufactured by Shanghai Dasheng Health Products Manufacturing in China.

It’s unclear exactly what’s wrong with the products – essential for COVID-19 protection for medical workers – but the United States Food and Drug Administration and Centers for Disaster Control and Prevention claim that the company “failed to control the design, labeling and quality management” of the masks.

All approvals for the N95s produced by Shanghai Dasheng were revoked on August 13, meaning they are no longer authorized for emergency use and “may no longer be manufactured, assembled, sold or distributed” in the United States. United.

N95 masks are the ones that have “a very tight facial fit and very efficient filtration of airborne particles,” according to the FDA.

While the warning has been sent to healthcare professionals who work closely with patients with COVID-19, it doesn’t hurt to check whether the box of N95 masks you purchased online or in stores stores did the trick.

Example of typical markings on approved N95 respirators. CDC

Look for a seven-digit approval number starting with the letters “TC-” at the bottom of your mask. If your mask has any of the numbers listed below, it is among those that have been revoked for quality issues:

TC-84A-4329, TC-84A-4330, TC-84A-4331, TC-84A-4332, TC-84A-4334, TC-84A-4335, TC-84A-4336, TC-84A-4337, TC- 84A-4398, TC-84A-4399, TC-84A-4400, TC-84A-4401, TC-84A-4463, TC-84A-4464, TC-84A-4465, TC-84A-4466, TC-84A- 4467, TC-84A-4468, TC-84A-4469, TC-84A-4470, TC-84A-4471, TC-84A-4472, TC-84A-4473, TC-84A-4483, TC-84A-4484, TC-84A-4485, TC-84A-4486, TC-84A-4487, TC-84A-8150, TC-84A-8425, TC-84A-8543, TC-84A-8544, TC-84A-8545, TC- 84A-8546, TC-84A-8547, TC-84A-8634, TC-84A-8635 and TC-84A-8636.

The FDA has said it will keep medical professionals and the public informed as new information becomes available.

Experts say masks should be used alongside vaccination to slow and prevent the spread of coronavirus, especially as more contagious variants tour the United States

More … than 38.8 million cases of coronavirus have been reported in the United States, and more than 637,000 people have died from COVID-19 as of August 30, according to Johns Hopkins University.

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Katie Camero is a McClatchy National Real-Time Science reporter. She is a Boston University alumnus and has reported for the Wall Street Journal, Science and The Boston Globe.

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