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The U.S. Food and Drug Administration has issued an alert to health care providers about certain N95 respirator face masks.
The Centers for Disease Control and Prevention's National Institute for Occupational Safety and Health has revoked its approval of N95 respirator face masks manufactured by Shanghai Dashen Health Products Manufacturing Co.
The FDA said the approvals were revoked "because the company did not implement, maintain, and control a quality management system. All previously authorized Shanghai Dasheng respirators are no longer authorized for emergency use as a result of the loss of NIOSH-approval."
The FDA provided the NIOSH approval numbers that are no longer valid. The numbers appear on the respirator. This also includes other brands manufactured by Shanghai Dashen.
N95 and KN95 face masks have been in high demand since the onset of the COVID-19 pandemic. The FDA said, an N95 respirator face mask "is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. The edges of the respirator are designed to form a seal around the nose and mouth."
The revoked approval numbers are - 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 said there are "serious concerns with the quality" of the N95 respirator masks manufactured by Shanghai Dasheng.
The National Institute for Occupational Safety and Health maintains a list of equipment it has approved.
On its website, Shanghai Dasheng said the issue involves counterfeit masks using its company's NIOSH approval numbers.
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