China NMPA Product Recall - Hemodialysis, hemodiafiltration device

B. Braun (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of its hemodialysis devices and hemodialysis filtration devices, specifically affecting heparin pump products. The recall, indexed by the National Medical Products Administration (NMPA) under reference JGXX-2021-10125 and published on March 19, 2021, addresses a critical manufacturing defect. The primary issue identified is a missing screw washer situated between the screw head and the plastic gasket at the bottom of the heparin pump. This omission could lead to the loosening of screws and the pump mechanism itself during operational use. Such loosening presents a significant risk of reduced heparin delivery volume, potentially decreasing by up to 10% of the syringe volume, which could impact patient treatment efficacy. As a required action, B. Braun (Shanghai) Trading Co., Ltd. is recalling all affected hemodialysis and hemodialysis filtration devices, identified by Registration Certificate No.: 20173450590. The company provided a "Medical Device Recall Report Form" with detailed information on affected models, specifications, and batches. This voluntary recall aims to mitigate the identified safety risk associated with the faulty components.