China NMPA Product Recall - Injection pump

Kangfusheng (Shanghai) Trading Co., Ltd. initiated a Class II voluntary recall of several models of its injection pumps, as announced by the National Medical Products Administration (NMPA) on June 19, 2017. The recall was prompted by a identified safety concern: a potential risk of siphoning. This issue is attributed to damage to the back plate spring within the injection pump column. The company determined that this mechanical failure could compromise the proper functioning of the device, posing a risk to patients. The affected products include injection pumps with Registration Nos. 国械注进 20162542856, 国械注进 20162542857, and 国食药监械（进）字2012第2542870号(更). Kangfusheng (Shanghai) Trading Co., Ltd. is taking proactive steps to address this defect by removing the affected batches from circulation. This action falls under the regulatory oversight of the NMPA, which is responsible for ensuring the safety and efficacy of medical devices in China. The specific models, specifications, and batch numbers for the recalled devices are detailed in an attached "Medical Device Report Form," instructing stakeholders to refer to it for comprehensive product identification. This voluntary recall highlights the company's commitment to product safety and compliance with regulatory standards.