# China NMPA Product Recall - Medical surgical masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/chongqing-hualun-medical-equipment-co-ltd/9677efc8-2834-40f7-adf1-026fd9661cac/
Source feed: China

> China NMPA product recall for Medical surgical masks by Chongqing Hualun Medical Equipment Co., Ltd. published October 30, 2019. Recall level: Level 3 Recall. Chongqing Baina Medical Device Co., Ltd. initiated a voluntary Class III medical device recall for i

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Chongqing Baina Medical Device Co., Ltd. voluntarily recalls medical surgical masks
- Company Name: Chongqing Hualun Medical Equipment Co., Ltd.
- Publication Date: 2019-10-30
- Product Name: Medical surgical masks
- Recall Level: Level 3 Recall
- Recall Reason: The ear loops of the medical surgical mask do not meet the technical requirements for breaking strength.
- Discovering Company: Chongqing Baina Medical Equipment Co., Ltd.
- Manufacturing Company: Chongqing Hualun Medical Equipment Co., Ltd.
- Summary: Chongqing Baina Medical Device Co., Ltd. initiated a voluntary Class III medical device recall for its medical surgical masks (batch number: 20181105) following a national random inspection conducted on April 10, 2019. The inspection revealed that the ear loop breaking strength of the masks did not meet specified technical requirements, indicating a potential product defect and risk. This recall is overseen within the regulatory framework of the National Medical Products Administration (NMPA), with formal reports submitted to the Provincial Food and Drug Administration. The company's required actions involve a structured, multi-departmental response. The sales department is tasked with tracing product distribution and quantities. The Quality Management Department (QMD) is responsible for formulating an Investigation and Evaluation Report, developing a comprehensive Recall Plan detailing implementation, timeframe, and communication strategies, and overseeing the recall's execution. A Management Representative will submit all relevant reports and plans to the regulatory authorities for record-keeping. Furthermore, the Business Department will issue recall notices to affected customers, while the warehouse will manage the inventory of recalled items. Finally, the QMD will organize the analysis, develop a disposal plan for the recalled products, and verify its effective implementation.

Company: https://www.globalkeysolutions.net/companies/chongqing-hualun-medical-equipment-co-ltd/3dd387c0-c64b-43f7-ae61-825360186cb5/