China NMPA Product Recall - Infusion pump

Changsha Biyang Medical Device Co., Ltd. has voluntarily initiated a Class III recall for its infusion pumps (Model BYS-820S, Registration No. 湘食药监械（准）字2014第2540079号) under the regulatory oversight of the National Medical Products Administration (NMPA) of China. The recall, reported on September 28, 2016, addresses several manufacturing non-conformities identified by the company. Key issues include incorrect external markings on equipment components, specifically the nameplate displaying a DC symbol where an AC symbol was required. Additionally, the instruction manual failed to clearly indicate the protective grounding for the three-pin power socket. A significant concern was also identified with the device's audible alarm system, where the interval between the "low battery" alarm and the machine's automatic shutdown was excessively short when operating on internal battery power. In response, Changsha Biyang Medical Device Co., Ltd. committed to corrective actions including updating nameplate markings, revising the instruction manual to incorporate the grounding indicator, adjusting machine parameters for units with non-compliant battery discharge, and conducting individual testing on each machine to ensure compliance. The company confirmed that no customer complaints or adverse events have been reported related to these issues.