China NMPA Product Recall - Medical temperature control blanket

Beijing Dawei Tongchuang Medical Equipment Co., Ltd. voluntarily initiated a Level II recall for specific batches of its Medical Temperature Control Blankets, including models DWK-II C09001 through DWK-II C09020, as reported to the National Medical Products Administration (NMPA) on October 23, 2017. The primary issue identified was an administrative error: the labels and instructions incorrectly displayed the production license number as "京药监械生产许20030002号" instead of the correct "京食药监械生产许20030002号". The company explicitly stated that this labeling discrepancy is not related to the product's safety or performance. Under the NMPA's regulatory framework for medical devices, the company is required to take specific corrective actions. These include promptly notifying all affected customers about the labeling error. Furthermore, Beijing Dawei Tongchuang Medical Equipment Co., Ltd. committed to deploying engineers or authorized distributors to customer sites. Their task is to rectify the affected products at no cost by replacing the incorrect labels with accurate ones and either providing new, correct instruction manuals or obscuring the erroneous information within existing manuals. This voluntary recall ensures compliance with regulatory standards for medical device documentation.