China NMPA Product Recall - Self-adhesive dressing

Minnesota Mining Manufacturing Medical Devices (Shanghai) Co., Ltd. initiated a Class III voluntary recall of its self-adhesive dressings, as reported by the National Medical Products Administration (NMPA) on February 21, 2017. The primary violation involved product labels lacking production dates, affecting batches produced between August and December 2016. This non-compliance breaches the new "Regulations on the Management of Instructions and Labels for Medical Devices" (Order No. 6 of the State Food and Drug Administration), which mandates the inclusion of production dates on medical device labels. In response, the company has undertaken several corrective actions. They formally notified affected customers and are actively collecting and relabeling products through returns and exchanges to ensure all items on the market display the required production date. Furthermore, Minnesota Mining Manufacturing Medical Devices (Shanghai) Co., Ltd. is implementing a label change process to update label content to meet regulatory standards. To prevent future recurrences, a "Label Approval Management System" (QAP1301) has been developed, and associated training conducted. The company also committed to providing regular progress reports on the recall to the Shanghai Food and Drug Administration.