China NMPA Product Recall - Single-use extracorporeal circulation blood circuit

B. Braun (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of its single-use extracorporeal blood circuits, as announced by the National Medical Products Administration (NMPA) on August 19, 2021. The recall addresses two primary labeling issues identified by the company. First, product labels and instructions incorrectly displayed an outdated registration certificate number (国械注进20163451626) instead of the current one (国械注进20163101626). This error affected the outer box, outer packaging, and individual component bags. Second, discrepancies were found in the expiration date printing. The outer box and package labels sometimes indicated an expiration beyond four years. Following a renewal of the product's registration certificate, the package expiration date was fixed at four years from the assembly date, while individual components retained a five-year shelf life. Before the renewal, package expiration was calculated variably based on the earliest expiring component, up to five years. The company's risk analysis determined that despite these labeling errors, the product's safety and performance are not compromised, as the kit's overall expiration date considers all components and the product itself functions normally. The recall is being conducted under NMPA regulations, with specific details on affected models and batches available in a separate Medical Device Recall Event Report Form.