China NMPA Product Recall - Pump blood transfusion set

B. Braun Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class II recall of specific blood pump sets on July 23, 2019. This action was prompted by findings during product monitoring, which revealed critical packaging errors. The identified issue was that some blood pump sets contained infusion sets unsuitable for blood transfusion, posing a significant risk to patient safety and potentially delaying crucial medical treatments. The National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration oversaw this regulatory action. The recall pertains to blood pump sets registered under Certificate No. 20173661232. The company recognized the potential for patient harm due to these mispackaged products, leading them to proactively remove affected batches from the market. This voluntary recall underscores the importance of stringent quality assurance processes within the medical device industry to prevent product non-conformities that could compromise patient care. Detailed information on the affected product models, specifications, and batch numbers is available in the accompanying Medical Device Recall Event Report Form.