China NMPA Product Recall - Medical tissue adhesive

B. Braun Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class II recall for its medical tissue adhesive, as published by the National Medical Products Administration (NMPA) on March 17, 2021. This action was prompted by post-market surveillance, which revealed that the adhesive did not consistently polymerize completely after application, leading to lower-than-expected adhesion. Although the product's use in China is limited to minimal tension skin wounds and simple lacerations, and the company assessed a low probability of serious harm during normal use, the recall addresses potential risks in extreme situations. The regulatory framework involving the NMPA and the Shanghai Municipal Drug Administration oversees this recall. B. Braun Medical (Shanghai) International Trading Co., Ltd. is proactively taking steps to mitigate product quality concerns. Detailed information regarding the affected product models and batches is available in a separate Medical Device Recall Event Report Form. The company is ensuring product efficacy and patient safety by addressing this identified issue.