China NMPA Product Recall - Diffused braided artificial blood vessels

Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class III recall for its dipolluted braided artificial blood vessels. This action, reported to the National Medical Products Administration (NMPA) via the Shanghai Municipal Drug Administration on July 12, 2021, stems from a reported complaint concerning inconsistencies between the specifications displayed on the inner and outer packaging labels of the affected products. The company undertook this recall out of a commitment to patient safety and to ensure the continued safe use of its medical devices. While specific inspection dates are not provided in the document, the recall decision was made by the manufacturer upon receiving the complaint. The regulatory framework under which this recall proceeds is established by the NMPA, overseeing medical device safety. Maikewei (Shanghai) Medical Equipment Co., Ltd. is taking the required action of removing the affected products from the market to address the labeling discrepancies and uphold product integrity. Further details on specific models, specifications, and serial numbers are available in an attached Medical Device Recall Event Report Form.