China NMPA Product Recall - wound dressing

Minnesota Mining Manufacturing Medical Devices (Shanghai) Co., Ltd. voluntarily initiated a Class III recall for specific wound dressing products, as reported on January 16, 2017, and publicly announced on February 21, 2017. The primary violation involved the absence of production dates on product labels, which contravenes the updated Chinese regulatory framework, specifically the "Regulations on the Management of Instructions and Labels for Medical Devices" (Order No. 6 of the State Food and Drug Administration). To address this, the company has undertaken several actions. These include formally notifying affected customers and actively adding the missing production date information to products via a return/exchange program. Additionally, the company is implementing a corrective action to revise labels for future compliance and has developed a "Label Approval Management System" (QAP1301) with associated training to prevent similar issues. Minnesota Mining Manufacturing Medical Devices (Shanghai) Co., Ltd. will regularly update the Shanghai Food and Drug Administration on the recall's progress, demonstrating a thorough approach to resolving the identified non-compliance.