China NMPA Product Recall - wound dressing

Minnesota Mining Manufacturing Medical Devices (Shanghai) Co., Ltd., also known as 3M Medical, initiated a voluntary Class III recall of its wound dressings, as published by the National Medical Products Administration (NMPA) on March 1, 2017. The recall was reported on January 16, 2017. The primary issue identified was the absence of production dates on the labels of certain wound dressing products. This non-compliance contravenes the "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 China. Approximately 6346 boxes of products were affected, with 4458 boxes having been sold within China. In response, the company has undertaken several corrective actions. They formally notified affected customers and implemented a process for product returns or exchanges to ensure all distributed products correctly display the production date. Furthermore, Minnesota Mining Manufacturing Medical Devices (Shanghai) Co., Ltd. committed to a label corrective action to revise label content to meet current regulatory standards. To prevent recurrence, a "Label Approval Management System" (QAP1301) was developed and associated training conducted, aimed at ensuring all labels are reviewed for consistency with registration information and full regulatory compliance. The company will also provide regular updates on the recall's progress to the Shanghai Food and Drug Administration.