Stop Using Certain Shanghai Dasheng N95 Respirators

IPSIS Patient Safety Alert 08/26/2021: Stop Using Certain N95 Respirators Manufactured by Shanghai Dasheng

This is an important alert from the International Pain and Spine Intervention Society. IPSIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. In such cases neither IPSIS nor the FDA endorse either the product or the company.

ISSUE: 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.

Click here for more information from the CDC on the revocation of Shanghai Dasheng Health Products Manufacture Co., Ltd.
approvals.

RECOMMENDATION: The FDA recommends health care facility risk managers, procurement staff, and health care personnel to:

• In accordance with the CDC’s 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. 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 your group purchasing organization, 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. See “Reporting Problems to the FDA” below.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Adverse Event Reporting Program:

• Complete and submit the report online; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178
• Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
• Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
  

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