China NMPA Product Recall - Annuloplasty Ring

Edwards Lifesciences LLC, working with its subsidiary Edwards (Shanghai) Medical Supplies Co., Ltd., has initiated a voluntary Class III recall of its annuloplasty rings. This action, reported by the National Medical Products Administration (NMPA) on January 11, 2024, addresses a critical labeling error for products distributed in Brazil. The primary issue involves a discrepancy where the Portuguese product name printed on the label does not align with the correct product name for the device. The affected annuloplasty rings are identified under National Medical Device Registration Certificate No. 20163133017. While specific inspection dates are not provided, this recall is a direct response to the identified labeling inconsistency, managed under the NMPA's regulatory framework. The Class III classification suggests that the issue is unlikely to cause severe adverse health consequences. Edwards Lifesciences LLC is undertaking proactive measures to correct this labeling error, which is crucial for accurate product identification and patient safety. Detailed information regarding the specific product specifications and batch numbers involved in this recall is available in the "Medical Device Recall Event Report Form" for all relevant parties. This voluntary recall emphasizes the company's adherence to regulatory compliance and commitment to maintaining product integrity within the medical device industry.