China NMPA Product Recall - Disposable continuous spinal anesthesia catheter kit

B. Braun Medical (Shanghai) International Trading Co., Ltd. initiated a Class II recall for its disposable continuous spinal anesthesia catheter kits following internal quality testing. The company, a subsidiary of B.Braun Melsungen AG, identified that the polyvinyl chloride membrane (C-film) in affected products might contain voids, compromising the sterile barrier system essential for patient safety. This voluntary recall, reported to the National Medical Products Administration (NMPA) on September 19, 2016, and publicly announced on December 7, 2016, impacts various batches of SPINOCATH G24/G29 and SPINOCATH G22/G27 models, with 5800 units sold in China. The products are used for local anesthesia or intramural analgesia below the TH12 level. In response to this critical quality issue, B. Braun implemented several corrective actions. These include locking all affected products within their ordering system, verifying and freezing existing inventory in China, tracking and notifying all customers with recall notices, and arranging for the return of all unused products. This proactive measure ensures compliance with regulatory standards and mitigates potential risks associated with compromised medical devices.