China NMPA Product Recall - Pleural cavity and pericardial drainage kit

The National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Cook Incorporated for specific batches of its pleural and pericardial drainage kits. Cook (China) Medical Trading Co., Ltd. reported this action due to a critical labeling error involving incorrect expiration dates printed on the product labels. This mislabeling could potentially lead to the use of expired products, posing a risk to patient safety. The recall was publicly announced on March 13, 2020, under NMPA Index No. JGXX-2020-10149. The regulatory framework for this action falls under the NMPA's authority, which oversees medical device safety in China. Cook Incorporated, the manufacturer (Registration Certificate No.: 20173151693), is taking proactive steps to remove the affected products from the market. The required action for this recall is the removal of the non-compliant drainage kits, with detailed information on specific models and batches available in the accompanying Medical Device Recall Event Report Form. This voluntary recall emphasizes the manufacturer's responsibility to ensure accurate product information and maintain patient safety standards.