China NMPA Product Recall - Extracorporeal circulation tubing

Beijing Midas Medical Device Co., Ltd. initiated a voluntary Level 3 recall of its Extracorporeal Circulation Tubing (adult type, production batch number: 1803-09) following a 2018 sampling inspection. The Beijing Municipal Medical Device Administration identified a failure in the product's particulate contamination item, rendering it non-compliant. This critical issue prompted the company to act under the oversight of the National Medical Products Administration (NMPA) and its local counterpart. Upon receiving the inspection results, Beijing Midas Medical Device Co., Ltd. promptly convened its technical, quality inspection, production, and sales departments. The company conducted a comprehensive investigation into the reported non-compliance and implemented corrective actions. These actions included the recall of all affected products and the destruction of any unused inventory from the identified batch. The recall affected 218 units of the product sold in China, intended for single use in patients undergoing open-heart surgery with extracorporeal circulation.