China NMPA Product Recall - Absorbable dressings for use with artificial skin

On December 20, 2023, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Gunze Medical Co., Ltd. The manufacturer is recalling its artificial skin product, utilized in absorbable dressings and registered under National Medical Device Registration Certificate No. 20163. The recall was reported by Gunze Medical Devices (Shenzhen) Co., Ltd., citing an error in the instruction manual label for products intended for overseas markets as the primary issue. A Class III recall signifies that while a deficiency exists, the use of or exposure to the affected product is unlikely to lead to serious adverse health consequences for patients or users. This proactive measure by Gunze Medical Co., Ltd. addresses a documentation inaccuracy rather than a product safety or performance defect. The company is committed to ensuring accurate product information across all markets. Detailed information concerning the specific models, specifications, and batch numbers of the recalled artificial skin is available in the "Medical Device Recall Event Report Form" attached to the NMPA's official notification. This action underscores the importance of precise labeling and adherence to regulatory standards for medical devices globally.