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SILVER SPRING, MD - On Aug. 25, representatives of the U.S. Food and Drug Administration notified health care professionals to "stop using certain N95 respirators manufactured by Shanghai Dasheng."

Though the advisory was targeted to "health care facility risk managers, procurement staff and health care personnel," the face masks were also sold to individual consumers by certain retailers across the nation.

The FDA's announcement listed 38 lot numbers of masks produced by Shanghai Dasheng as no longer having approval from the National Institute for Occupational Safety and Health "...because the company did not implement, maintain and control a quality management system." Representatives noted that some of the masks were "manufactured by Shanghai Dasheng and marketed using another brand name."

According to the FDA, there are "serious concerns with the quality of certain N95 respirators manufatcured by Shanghai Dasheng. The FDA is assessing the extent of the concerns and is working with NIOSH to understand and address the issue." Agency representatives instruct recipients of the Aug. 25 advisory, "In accordance with the CDC's (Centers for Disease Control and Prevention) recommendation, stop using N95 respirators manufactured by Shanghai Dasheng and intended for emergency use (including those bearing other brand names). Replace any Shanghai Dasheng respirators with respirators approved by NIOSH that are found on the NIOSH Certified Equipment List."

The announcement sent to health care professionals does not address situations involving retailers that previously sold the masks to individual consumers.

Katie Camero, reporting on Aug. 30 for Miami Herald, notes, "Although the warning was directed to health care professionals who work closely with COVID-19 patients, it doesn't hurt to check if the box of N95 masks you purchased online or from stores made the cut."

According to an Aug. 28 report by Deb Kiner of PennLive, "On its website, Shanghai Dasheng said the issue involves counterfeit masks using its company's NIOSH approval numbers."

The 38 lot numbers from Shanghai Dasheng no longer approved for use are listed below. The numbers can be found printed on each individual mask and on the packaging sold at retail.

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 advisory can be viewed in its entirety at https://www.fda.gov/medical-devices/medical-device-recalls/stop-using-certain-n95-respirators-manufactured-shanghai-dasheng-letter-health-care-providers.