China NMPA Product Recall - Central venous catheter

B. Braun Melsungen AG, via its agent B. Braun Medical (Shanghai) International Trading Co., Ltd., initiated a Class I voluntary recall of specific Central Venous Catheters (Registration Certificate No. 20143775019) on March 12, 2019. This action, overseen by the National Medical Products Administration (NMPA) of China, concerns 36,410 units imported since 2016.

The primary issue stems from a potential deviation in a supplier-provided component: a packing material intended to seal the dead space between the catheter's lateral opening and tip. This material may have shifted, creating a risk of infusion obstruction or embolism, although no patient injuries have been reported to date. The recall specifically targets various batch numbers of the CERTOFIX QUATTRO V 820 Four-lumen Central Venous Catheter.

As required by the NMPA, B. Braun must undertake several critical actions. These include verifying and freezing all remaining affected product inventory within China, issuing recall notices to all customers to ensure comprehensive awareness, and retrieving all unused recalled products from customers for local destruction, alongside any frozen stock. This proactive measure aims to mitigate potential patient safety hazards associated with the identified component issue.