China NMPA Product Recall - MynxGrip Vascular Closure Devices

The National Medical Products Administration (NMPA) issued a notice on January 23, 2024, detailing a voluntary Class II recall initiated by Cardinal Health. The manufacturer, Cardinal Health, along with Cardinal Health (Shanghai) Medical Devices Co., Ltd., is recalling its MynxGrip Vascular Cl Devices, which are registered under National Medical Device Registration Certificate No. 20233130334. The primary issue identified is incorrect labeling information found on the outer packaging of the affected product. This regulatory action falls under the NMPA's oversight, with the Class II designation indicating that while the issue is not immediately life-threatening, it could potentially cause temporary or reversible adverse health consequences. In response to this non-compliance, Cardinal Health has undertaken a voluntary recall to correct the identified discrepancy. Specific details regarding the models, specifications, and batch numbers of the affected devices are provided in the "Medical Device Recall Event Report Form" associated with this announcement. The company's proactive measure aims to ensure product integrity and adherence to regulatory standards for medical device labeling.