China NMPA Product Recall - Percutaneous nephrostomy catheter kit

Cook Incorporated, through its subsidiary Cook (China) Medical Trading Co., Ltd., has initiated a voluntary Class II recall for specific models and batches of its percutaneous nephrostomy catheter kits. This action was reported on September 17, 2020, and publicly announced by the National Medical Products Administration (NMPA) on September 18, 2020, under Index No. JGXX-2020-10470. The core issue prompting this recall is the heightened risk of adverse events, such as catheter breakage, bending, scale buildup, migration, or infection, if the devices remain in the body for more than four weeks. These potential complications present significant patient safety concerns. Operating within the NMPA's regulatory oversight, identified by Registration Certificate No.: 20193022272, Cook Incorporated is taking the necessary step to retrieve all affected percutaneous nephrostomy catheter kits from the market. Detailed information regarding the specific models, specifications, and batch numbers involved in this recall is provided in the accompanying "Medical Device Recall Event Report Form," ensuring clear identification for all relevant parties.