China NMPA Product Recall - Drainage Catheter

Cook Incorporated, in conjunction with Cook (China) Medical Trading Co., Ltd., has initiated a voluntary Class III recall of its Drainage Catheter (National Medical Device Registration Certificate 20192142121). The recall was prompted by Cook Incorporated's discovery that certain batches of these catheters, specifically those distributed to Peru, were missing essential paper instructions. This action, reported on February 2, 2026, falls under the regulatory oversight of the National Medical Products Administration (NMPA). While no inspection dates are noted, the recall is a proactive measure taken by the manufacturer to address the identified product deficiency. Cook Incorporated is responsible for implementing the recall and providing detailed information on affected models and batches through an attached Medical Device Recall Event Report Form, ensuring compliance with NMPA regulations regarding medical device safety and labeling.