China NMPA Product Recall - Absorbable surgical sutures

B. Braun Medical (Shanghai) International Trading Co., Ltd., acting as the agent for B. Braun Surgical SA, initiated a voluntary Class III recall of specific absorbable surgical sutures with needles (Registration No. 20143653379). This recall was reported in June 2017 and publicized by the National Medical Products Administration (NMPA) on July 19, 2017. The primary issue identified was that the needle connection strength of affected products, specifically Model C1078730 from Batch Number 116024, did not meet established Chinese regulatory standards. The root cause was attributed to the manufacturer's failure to accurately describe the unique characteristics of this special detachable suture within its Chinese registration documents. Despite no reported patient injuries, B. Braun implemented several corrective actions. These included notifying all affected customers and facilitating the return of the recalled products. Additionally, the company initiated a formal registration amendment process to revise the product's technical requirements, ensuring proper alignment with the relevant Chinese standards for this specific type of absorbable suture and compliance with the NMPA's regulatory framework.