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 various wound dressings, as announced by the National Medical Products Administration (NMPA) on February 21, 2017. The central issue was the absence of production dates on the product labels, which did not comply with China's new "Regulations on the Management of Instructions and Labels for Medical Devices" (Order No. 6 of the State Food and Drug Administration). This regulation mandates the inclusion of production dates on medical device labeling. The recall affected a total of 6,346 boxes of wound dressings imported or delivered to China, with 4,458 boxes sold domestically. To address the violation, the company took several actions: notifying affected customers, retrieving products for the addition of missing production date information, and implementing a corrective action plan for label modification. Additionally, 3M Medical developed a "Label Approval Management System" (QAP1301) and committed to training personnel to ensure future compliance and prevent recurrence of similar labeling deficiencies.