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 on January 16, 2017, and published by the National Medical Products Administration (NMPA) on February 21, 2017. The primary issue identified was the absence of production dates on the labels of certain product batches. This deficiency constituted a non-compliance with China's 'Regulations on the Management of Medical Device Instructions and Labels' (State Food and Drug Administration Order No. 6), which mandates the inclusion of production dates on all medical device labels. In response, the company undertook several corrective actions: formally notifying affected customers, adding missing production dates to products through a return/exchange program, and initiating a label modification process to ensure future compliance. Furthermore, Minnesota Mining Manufacturing Medical Devices (Shanghai) Co., Ltd. developed a 'Label Approval Management System' (QAP1301) and provided training to prevent similar labeling errors. The company is committed to regularly reporting its recall progress to the Shanghai Food and Drug Administration.