China NMPA Product Recall - Medical temperature control blanket
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Beijing Dawei Tongchuang Medical Equipment Co., Ltd. initiated a voluntary Level III recall for 20 units of its Medical Temperature Control Blankets, specifically batches DWK-II C09001 through DWK-II C09020. This recall, reported on October 1, 2017, and published by the National Medical Products Administration (NMPA) on October 17, 2017, addresses an administrative error rather than a product safety concern. The main issue involved an incorrect production license number printed on the product labels and instructions for use. The incorrect serial 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." To rectify this, the company's required actions include informing all affected customers via email and dispatching engineers or authorized distributors. These personnel will correct the labels and instructions free of charge, ensuring regulatory compliance by replacing the erroneous labels and modifying or covering up incorrect content in the instruction manuals.
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