China NMPA Product Recall - Medical temperature control blanket

Beijing Dawei Tongchuang Medical Equipment Co., Ltd. has initiated a voluntary Level III recall for specific batches (DWK-II C09001-DWK-II C09020) of its Medical Temperature Control Blankets. This recall, overseen by the National Medical Products Administration (NMPA) and publicized on October 17, 2017, stems from the company's recent discovery of an error in the production license number. The labels and instructions incorrectly displayed "京药监械生产许20030002号" instead of the accurate "京食药监械生产许20030002号". The company assures that this is solely a documentation and labeling discrepancy and does not compromise product safety or functionality. To address this regulatory non-compliance, Beijing Dawei Tongchuang Medical Equipment Co., Ltd. is undertaking several corrective actions. These include emailing affected customers to inform them of the issue. Additionally, the company will dispatch engineers or authorized distributors to perform on-site corrections free of charge, which involves replacing the original labels with corrected ones and either replacing or covering any inaccurate content within the product's instructions for use. This ensures all affected medical devices meet regulatory standards.