China NMPA Product Recall - Esteem+ One Piece Drainable Ostomy Pouch

On November 14, 2022, the National Medical Products Administration (NMPA) published a notice regarding a voluntary Class III recall initiated by ConvaTec Inc. The manufacturer, through ConvaTec (China) Medical Supplies Co., Ltd., reported an issue with certain models and batches of its Esteem+ One Piece Drainable Ostomy Pouch. The core problem identified was the difficulty in removing the silicone backing paper from the product. This defect could potentially hinder the proper application and functionality of the medical device, impacting its intended use by patients. The NMPA serves as the regulatory authority overseeing medical device safety and quality within China, under whose framework this recall is being conducted. Although specific inspection dates are not detailed in this document, the publication date marks the official announcement and dissemination of the recall information. Required actions include the proactive withdrawal of the affected products from the market by ConvaTec Inc. Detailed information concerning the specific models, specifications, and batches subject to this recall is made available through a 'Medical Device Notice' and an accompanying 'Medical Device Recall Event Report Form.' This voluntary action highlights the manufacturer's commitment to product integrity and patient safety in adherence to regulatory standards.