China NMPA Product Recall - Hemodialysis water treatment system

B. Braun (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of its hemodialysis water treatment system, identified by Registration Certificate No.: 20182102622. This action, published on May 29, 2019, was prompted by a printing error discovered on the product label. The recall event was reported through the Shanghai Food and Drug Administration Medical Device Recall 2019-120 and is overseen by the National Medical Products Administration (NMPA). While no specific inspection dates were provided, the recall itself serves as a corrective measure under the regulatory framework of medical device oversight in China. A printing error on a medical device label, even if minor, necessitates a recall to ensure accuracy of product information, proper usage, and patient safety, aligning with established quality control and regulatory compliance standards for medical devices. The company is required to provide detailed information on affected models, specifications, and batch numbers through a Medical Device Recall Event Report Form.