China NMPA Product Recall - sterilizer

On October 20, 2020, Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class III recall for its HS6617 model sterilizers. The company discovered incorrect serial numbers on the Chinese labels of two specific sterilizer units, prompting this action out of responsibility to its customers. The recall is overseen by the National Medical Products Administration (NMPA), the regulatory body in China. A Class III recall indicates that use of, or exposure to, the affected product is not likely to cause adverse health consequences. The required action involves the retrieval of these mislabeled sterilizers from the market, with detailed information on affected product models, specifications, and serial numbers available in a "Medical Device Recall Event Report Form" provided by the company. This self-initiated recall demonstrates the company's proactive approach to product quality and regulatory compliance.