China NMPA Product Recall - Medical temperature control blanket

Beijing Dawei Tongchuang Medical Equipment Co., Ltd. initiated a voluntary Level III recall of its Medical Temperature Control Blankets, specifically model DWK-II (batches DWK-IIC09001-DWK-IIC09020, affecting 20 units in China). The company reported the issue on October 1, 2017, with the recall publicly announced by the National Medical Products Administration (NMPA) on October 17, 2017. The primary issue discovered by the company was an incorrect production license number printed on the product labels and instructions for use. The erroneous number "京药监械生产许20030002号" was used instead of the correct "京食药监械生产许20030002号". This discrepancy, while a regulatory non-compliance under the NMPA framework, has been confirmed to be unrelated to the safety or performance of the medical devices. As required actions, Beijing Dawei Tongchuang Medical Equipment Co., Ltd. is notifying affected customers via email. Furthermore, the company will deploy engineers or authorized distributors to correct the non-compliance on all affected products at no cost. This correction involves physically replacing the incorrect labels with updated versions and amending or covering the erroneous content within the product instructions to ensure full regulatory compliance.