China NMPA Product Recall - Medical temperature control blanket

Beijing Dawei Tongchuang Medical Equipment Co., Ltd. initiated a voluntary recall of its medical temperature control blankets on October 23, 2017. The recall, classified as Level II by the National Medical Products Administration (NMPA), was prompted by a labeling inaccuracy rather than a product safety concern. The issue involved the incorrect production license number displayed on the labels and instruction manuals for multiple batches (DWK-IIC09001-DWK-IIC09020) of their medical temperature control blankets. Specifically, the number "京药监械生产许20030002号" was printed instead of the correct "京食药监械生产许20030002号". This administrative discrepancy affects products registered under 京械注准20162580765, with 20 affected batches produced and 10 units sold domestically. To resolve this, Beijing Dawei Tongchuang Medical Equipment Co., Ltd. is required to inform all affected customers about the error. Furthermore, the company will dispatch engineers or utilize distributors to provide on-site rectification, including free replacement of incorrect labels and instruction manuals, or covering the erroneous content within the existing manuals, ensuring full compliance with regulatory standards.