China NMPA Product Recall - Disposable humidifier bottles

On December 15, 2020, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Cook (China) Medical Trading Co., Ltd. This action stemmed from an investigation by the manufacturer, Cook Australia Pty Ltd, which identified a manufacturing defect. The issue involves a potential silicone stopper displacement in a small number of disposable humidifier bottles. These bottles are components used with tabletop incubators (Registration Certificate No.: 国械注进20162185127). The recall specifically targets affected batches of these disposable humidifier bottles that are still within their expiration date. Notably, this recall does not require the return of products. Instead, Cook (China) Medical Trading Co., Ltd. is focusing on notifying affected customers and providing guidance. Customers are instructed on recommended pre-use testing methods to help them identify the aforementioned defects. The regulatory oversight for this recall falls under the NMPA, ensuring patient safety and product quality within the medical device sector in China. Further details regarding specific product models, specifications, and batch numbers are available in the "Medical Device Recall Event Report Form."