Stop using these N95 masks, FDA says. There are ‘serious concerns’ with their quality


Olde Hornet

Well-Known Member

Federal health officials are warning health care professionals about “serious concerns” regarding the quality of certain N95 masks made by Shanghai Dasheng Health Products Manufacturing in China.

It’s unclear what is specifically wrong with the products — critical for protection against COVID-19 for medical workers — but the U.S. Food and Drug Administration and Centers for Disease Control and Prevention say the company “failed to control the design, labeling, and quality management” of the masks.

All approvals for N95s produced by Shanghai Dasheng have been revoked as of Aug. 13, meaning they are no longer authorized for emergency use and “may no longer be manufactured, assembled, sold or distributed” in the U.S.

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 If your mask is marked with any of the numbers listed below, then it is among those that have been revoked for quality concerns:

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.
 

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