China NMPA Product Recall - Stoma base plate Skin Barrier

The National Medical Products Administration (NMPA) reported on June 17, 2022, a voluntary Class III recall initiated by ConvaTec Inc., the manufacturer, and reported by ConvaTec (China) Medical Supplies Co., Ltd. The recall, detailed in a report dated June 16, 2022, addresses a quality issue with specific models and batches of the company's stoma baseboard Skin Barrier (Registration Certificate No.: 20200110). The primary concern involves product defects, specifically delamination or tearing of the adhesive edge on the stoma baseboard. This issue could potentially compromise the product's integrity and performance. As a required action under the NMPA's regulatory framework for medical devices, ConvaTec Inc. has proactively undertaken this recall to ensure patient safety and product quality. Further details regarding the affected product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form" attachment.