China NMPA Product Recall - Savary-Gilliard Dilators

On September 2, 2024, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by manufacturer Wilson-Cook Medical Incorporated. This action followed a report from Cook (China) Medical Trading Co., Ltd. The recall specifically concerns Savary-Gilliard Dilators, registered under National Medical Device Registration Certificate 20152024227.The main issue identified is a critical discrepancy between the model number indicated on the product packaging and the actual medical device model inside. This labeling error could lead to incorrect product identification, potentially impacting patient safety or the effectiveness of medical procedures if the wrong device is selected based on packaging information.Wilson-Cook Medical Incorporated is undertaking the voluntary recall to address this packaging inconsistency. However, it is explicitly stated that the specific models, specifications, and batches of the affected Savary-Gilliard Dilators were not imported into the Chinese market. Consequently, no direct actions are required from the Chinese public or healthcare providers regarding product availability within China. This NMPA notification serves to acknowledge the regulatory compliance and corrective measures taken by Wilson-Cook Medical Incorporated concerning their product labeling accuracy.