China NMPA Product Recall - Absorbable surgical sutures

B. Braun Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class III recall of Absorbable Surgical Sutures with Needles (Registration No.: CFDA (Imported) No. 20143653379). The recall, publicly announced on August 8, 2017, and reported to the National Medical Products Administration (NMPA) on June 20, 2017, was prompted by the product's failure to meet Chinese standards for needle connection strength. The underlying cause was attributed to the manufacturer, B. Braun Surgical SA, not accurately detailing the unique characteristics of this detachable suture in its Chinese registration documents. Although no quality complaints or patient injuries were reported, 31 boxes from Batch Number 116024, Model C1078730, were distributed in China. Corrective actions included sending recall notices to customers, retrieving the affected products, and initiating a registration amendment process to ensure the product's technical requirements accurately reflect the specific standards for this type of suture, thereby ensuring compliance with Chinese regulatory frameworks.