China NMPA Product Recall - AMS 800 Urinary Control System

The National Medical Products Administration (NMPA) announced a Class II voluntary recall of the AMS 800 Urinary Control System, initiated by manufacturer American Medical Systems, Inc. The recall, publicly reported on August 9, 2019, by Boston Scientific International Medical Trading (Shanghai) Co., Ltd., addresses a significant product issue: a potential discrepancy between the actual size of the accessory cuff and its marking on the packaging. This inconsistency could lead to improper use or compromise patient safety. The regulatory oversight for this action falls under the NMPA in China, with a Class II designation indicating a situation where the probability of serious adverse health consequences is remote, or temporary or medically reversible adverse health consequences may occur. American Medical Systems, Inc. is undertaking this voluntary action, requiring affected parties to consult the 'Medical Device Recall Table' for precise details on product models, specifications, and batch numbers to facilitate the proper management and return of the devices. This measure highlights the company's commitment to maintaining product integrity and adhering to regulatory standards.