China NMPA Product Recall - Self-adhesive dressing

Minnesota Mining Manufacturing Medical Devices (Shanghai) Co., Ltd. initiated a Class III voluntary recall for its Self-adhesive Dressings, as announced by the National Medical Products Administration (NMPA) on February 21, 2017, following an internal discovery reported on January 16, 2017. The core issue was the omission of production dates on certain product labels, which affected units sold in China and those imported/exported, totaling 1346 and 2531 boxes respectively. This violated China's "Regulations on the Management of Instructions and Labels for Medical Devices" (Order No. 6 of the State Food and Drug Administration), which mandates clear production date labeling. In response, the company has undertaken several corrective measures. These include notifying affected customers, implementing product returns and exchanges to add the missing production dates, and initiating a formal label change process to ensure compliance. Additionally, Minnesota Mining Manufacturing Medical Devices (Shanghai) Co., Ltd. developed a new "Label Approval Management System" (QAP1301) and conducted training for staff to prevent recurrence. The company also committed to providing ongoing progress reports to the Shanghai Food and Drug Administration.