China NMPA Product Recall - septal puncture needle

On October 8, 2021, Cook (China) Medical Trading Co., Ltd. initiated a voluntary Class I recall of its atrial septum puncture needles (model TSNC-18-71.0, Registration Certificate No.: 国械注进 20143155640). This action was taken due to a potential critical defect involving rust observed both inside and outside the affected medical devices. The recall was announced under the regulatory oversight of the National Medical Products Administration (NMPA) and specifically reported by the Shanghai Municipal Drug Administration. A Class I recall indicates the highest risk level, signifying a strong probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. The company is required to provide detailed information on the specific models, specifications, and batch numbers of the affected products in a "Medical Device Recall Event Report Form" to ensure comprehensive management of the recall process. This proactive measure aims to mitigate potential health risks to patients resulting from the identified product defect.