China NMPA Product Recall - Disposable connecting tube

Yangzhou Yangsheng Pharmaceutical Technology Co., Ltd. initiated a voluntary Level III recall for its Disposable Connecting Tubes, as announced by the National Medical Products Administration (NMPA) and the Jiangsu Provincial Drug Administration on April 6, 2022. The recall was prompted by adverse event reports from medical institutions, highlighting a critical product flaw: the three-way valve of the connecting tube may develop loose connections during use, potentially causing leakage. This defect presents a risk of harm to patients, especially when the devices are used as extension connections in operating rooms and intensive care units. The affected products, distributed within China, include batches 20200821 (3,000 units), 20210505 (6,000 units), and 20210805 (6,000 units), totaling 15,000 units. To address this, the company is actively communicating with distributors and hospitals to gather information on adverse events, diligently following up with customers, compiling comprehensive statistics on affected batch numbers, and ensuring all relevant stock is promptly identified and recalled. These actions are crucial for mitigating further risks and upholding product safety under NMPA's regulatory guidance.