China NMPA Product Recall - Disposable hemodialysis filters and tubing

On January 17, 2019, Baxter Medical Supplies Trading (Shanghai) Co., Ltd. initiated a voluntary Level II recall for its disposable hemodialysis filters and connecting tubing. This action was undertaken in accordance with the regulatory framework set by China's National Medical Products Administration (NMPA). The recall stemmed from critical product deficiencies that impacted the functionality of continuous blood purification devices. Issues identified included excessively long blood pump tubing, which prevented consumables from being fully installed on the machine, and a non-sealed state of the blood pump. These manufacturing deviations led to operational failures such as consumable pre-charging failures and machine alarms, necessitating medical staff to replace the faulty components with qualified consumables to ensure proper device operation. Detailed information on affected product models, specifications, and batches was made available in a Medical Device Recall Event Report Form.