A Chinese N95 manufacturer is making faulty masks the U.S. Food and Drug Administration has "serious concerns" about for healthcare workers.
"Stop using N95 respirators manufactured by Shanghai Dasheng and intended for emergency use [including those bearing other brand names]," the FDA wrote in a warning to healthcare providers.
"The FDA is alerting healthcare facility risk managers, procurement staff, and healthcare personnel about serious concerns with the quality of certain N95 respirators manufactured by Shanghai Dasheng. The FDA is assessing the extent of the concerns and is working with NIOSH to understand and address the issue."
N95 respirators manufactured by Shanghai Dasheng Health Products Manufacturing Co., Ltd. (Shanghai Dasheng) had all its respirator EUAs revoked by the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH). "because the company did not implement, maintain, and control a quality management system."
The FDA release outlined the approval code labels for the now-unauthorized masks:
"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 is recommending healthcare providers to stop using the respirators and replace them with ones with EUA approval:
"Contact group purchasing organizations, distributors, and state or regional resources if you are having difficulty obtaining NIOSH-approved respirators through existing vendors," the letter added.
The FDA is also asking for reports on issues with the Shanghai Dasheng masks.
"The FDA encourages healthcare facility risk managers, procurement staff, and healthcare personnel to report any adverse events or suspected adverse events experienced with these N95 respirators," it wrote.
"Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices."
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