The U.S. Food and Drug Administration (FDA) is alerting health care facility risk managers, procurement staff and health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacturing Co., Ltd. (Shanghai Dasheng). The Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) revoked all respirator approvals previously issued to Shanghai Dasheng 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.
Affected respirators can be identified by referring to the NIOSH approval numbers below and using the label reference from NIOSH. Respirators marked with a NIOSH approval label that includes any of the approval numbers listed below are no longer NIOSH-approved. In addition, respirators manufactured by Shanghai Dasheng and marketed using another brand name that include any of the approval numbers below are no longer NIOSH-approved:
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 and CDC recommend that health care facility risk managers, procurement staff, and health care personnel:
- 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. Respirators on the NIOSH Certified Equipment List are authorized under the Emergency Use Authorization (EUA) for NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency.
- Contact group purchasing organizations, distributors and state or regional resources if you are having difficulty obtaining NIOSH-approved respirators through existing vendors.
- Report any issues with the quality or performance of respirators to the FDA.
