China NMPA Product Recall - Central venous catheter

B. Braun Medical (Shanghai) International Trading Co., Ltd., acting as the responsible unit in China for manufacturer B. Braun Melsungen AG, initiated a voluntary recall of specific models and batches of Central Venous Catheters. This action, reported on December 23, 2016, and published by the National Medical Products Administration (NMPA) on January 13, 2017, was prompted by a manufacturing defect. The primary issue identified was an insufficiently tight connection between the Luer connector and the extension tube in certain central venous catheters. Although the defect's incidence rate was extremely low, B. Braun decided on a proactive recall to mitigate potential clinical risks associated with the product. Operating under the regulatory oversight of the NMPA, B. Braun Medical (Shanghai) performed a comprehensive verification. All affected central venous catheters imported into China were found to be in stock and had not been distributed or sold. The required actions involved the immediate identification and isolation of these products, which were subsequently prepared for return to the manufacturer. The company confirmed that the recall process for these specific batches within China was successfully completed, ensuring no potentially defective devices reached the market.