China NMPA Product Recall - Self-adhesive dressing

Minnesota Mining Manufacturing Medical Devices (Shanghai) Co., Ltd. issued a voluntary Class III recall for its self-adhesive dressings, as reported on March 1, 2017. The recall was initiated due to a labeling deficiency where certain product labels lacked required production dates. This non-compliance directly violates the "Regulations on the Management of Medical Device Instructions and Labels" (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 working to add the missing production date information to all impacted products through returns and exchanges, ensuring market compliance. Furthermore, Minnesota Mining Manufacturing Medical Devices (Shanghai) Co., Ltd. is initiating a label modification process to permanently revise label content to meet regulatory standards. To prevent future occurrences, a "Label Approval Management System" (QAP1301) has been developed, and relevant staff have received training. The company will also provide regular updates on the recall's progress to the Shanghai Food and Drug Administration. A total of 2531 boxes were affected, with 1346 boxes sold in China.