China NMPA Product Recall - Drainage Catheter

Cook Incorporated, through its subsidiary Cook (China) Medical Trading Co., Ltd., has initiated a voluntary Class II recall of its Drainage Catheters. The recall, reported to the National Medical Products Administration (NMPA) of China, stems from a critical labeling error: an incorrect expiration date printed on the product labels. This issue affects medical devices registered under National Medical Device Registration Certificate No. 20192142121. This action falls under the regulatory oversight of the NMPA, which governs medical device safety and quality in China. A Class II recall indicates a situation where product use may cause temporary or medically reversible adverse health consequences, or where serious adverse health consequences are remote. As a required action, Cook Incorporated is retrieving all affected Drainage Catheters from the market. Specific details regarding the impacted product models, specifications, and batch numbers are documented in an accompanying "Medical Device Recall Event Report Form." This proactive measure by Cook aims to ensure patient safety and compliance with medical device labeling regulations.