China NMPA Product Recall - Medical surgical masks

Chongqing Baina Medical Device Co., Ltd. voluntarily initiated a Level 3 recall of 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 required technical standards, posing a potential risk to users. The recall was formally reported on October 8, 2019, under the regulatory framework of the National Medical Products Administration (NMPA) and its provincial drug administration. Key actions required the company's sales department to investigate product distribution, and the Quality Management Department to formulate an Investigation and Evaluation Report and a comprehensive Recall Plan. This plan detailed the recall's scope, implementation methods, timeframe, communication, expected outcomes, and post-recall disposal measures. The Management Representative was responsible for submitting all documentation to the Drug Administration for record-keeping. Additionally, the business department issued recall notices to customers, the warehouse managed returned products, and the Quality Management Department oversaw the verification, analysis, and effective disposal of the recalled items to address the non-conformity and mitigate risks.