China NMPA Product Recall - Implantable vascular access systems and accessories

On October 15, 2021, the National Medical Products Administration (NMPA) publicly reported a voluntary Class III recall initiated by B.BRAUN MEDICAL (France) for specific implantable vascular access systems and accessories. The recall was facilitated by B.BRAUN Medical (Shanghai) International Trading Co., Ltd. The core issue driving this action was the omission of critical product model and Unique Device Identification-Device Identifier (UDI-DI) codes from the labels of the secondary packaging, or outer boxes, for the affected devices. While the primary product labels within the packaging were complete, the lack of this essential information on the exterior packaging posed a potential risk regarding product identification and traceability. The voluntary recall underscores the manufacturer's commitment to ensuring product integrity and compliance with NMPA's stringent regulatory requirements for medical device labeling and distribution. This proactive measure aims to rectify the labeling discrepancy and maintain the highest standards of safety and identification within the medical supply chain, ensuring that healthcare providers and patients can accurately identify and track these critical medical products.