China NMPA Product Recall - Peripherally inserted central venous catheter

B. Braun Melsungen AG, a German medical device manufacturer, initiated a voluntary global recall of several models of its peripherally transient central catheters. The recall, reported by the Shanghai Municipal Food and Drug Administration on May 4, 2014, and formally reported to the National Medical Products Administration (NMPA) on September 11, 2014, stems from internal testing conducted by the company. This testing revealed that prolonged indwelling time of the catheters could lead to accelerated aging of the material, causing stabilizers to precipitate. While B. Braun Melsungen AG confirmed no reported instances of patient injury or adverse reactions globally due to this issue, the company proceeded with the recall as a precautionary measure. The recall operates under the regulatory oversight of the NMPA, involving its provincial and municipal branches for supervision. B. Braun Medical (Shanghai) International Trading Co., Ltd., the responsible unit in China, is managing the local aspects. Required actions include notifying distributors via formal letters to halt sales and inform all customers, down to the end-users, to cease using the affected products. Distributors are mandated to collect all unused recalled items, which are then to be sealed and returned to B. Braun. This proactive measure aims to ensure patient safety and product integrity in line with medical device regulations.