China NMPA Product Recall - Dialog+

B. Braun Avitum AG, with its Chinese affiliate B. Braun Medical (Shanghai) International Trading Co., Ltd., initiated a medical device recall for its Dialog+ Hemodialysis Machines in China. This recall, formally reported to the National Medical Products Administration (NMPA) on September 30, 2010, stemmed from the discovery of a potential hazard during routine quality control. The issue involved a specific batch of an electronic component on the printed circuit board of the Safety Air Detector (SAD).

The identified problem could lead to a momentary malfunction of the SAD in extremely rare circumstances, particularly if air is simultaneously present in the venous blood circuit, potentially causing a temporary failure to alarm. While no near-misses or patient injuries have been reported, B. Braun proactively issued this recall. Under the NMPA's regulatory guidance, customers were notified on September 15, 2010, to cease using affected machines. The required action involved inspecting and updating the safety air detectors on all identified products, covering 36 units imported to China. Inspection and updates for sold products were slated for completion by September 22, 2010, with remaining stock addressed by September 30, 2010, demonstrating the company's commitment to patient safety and product quality.