China NMPA Product Recall - Medical temperature control blanket

Beijing Dawei Tongchuang Medical Equipment Co., Ltd. has initiated a voluntary Level III recall of its medical temperature control blankets. This action, reported on October 1, 2017, and published by the National Medical Products Administration (NMPA) on October 17, 2017, addresses a labeling inaccuracy. The primary issue concerns an incorrect production license number displayed on the product labels and instructions for use. Specifically, the number "京药监械生产许20030002号" was erroneously printed instead of the correct "京食药监械生产许20030002号" for batches DWK-IIC09001 through DWK-IIC09020 of the DWK-II model. The company explicitly stated that this discrepancy does not impact product safety or performance.

Under the regulatory oversight of the NMPA, the company is undertaking specific corrective measures. These include notifying all affected customers via email to inform them of the issue. Furthermore, Beijing Dawei Tongchuang Medical Equipment Co., Ltd. will dispatch its engineers or utilize authorized distributors to rectify the problem at no cost to the customers. This involves physically replacing the incorrect labels with accurate ones and either replacing or covering the erroneous content within the product instructions. This proactive recall ensures compliance with regulatory standards for medical device labeling.