China NMPA Product Recall - Extracorporeal circulation tubing

Beijing Midas Medical Devices Co., Ltd. initiated a voluntary Class III recall of its Extracorporeal Circulation Tubing following a critical quality issue identified in 2018. The recall, reported to the National Medical Products Administration (NMPA) and publicized on October 30, 2018, stemmed from findings during a 2018 sampling inspection conducted by the Beijing Medical Device Inspection Institute. The primary violation involved the failure of the particulate contamination test for extracorporeal circulation tubing, specifically the adult type, from production batches 1803-C and 1803-09. This product is critical for patients undergoing open-heart surgery, functioning as an extracorporeal blood access route. Upon discovering the issue, Beijing Midas Medical Devices Co., Ltd. leadership promptly organized a cross-departmental investigation involving technical, quality inspection, production, and sales teams. Under the NMPA's regulatory framework, the company's required actions included recalling all affected units, totaling 242 manufactured and 218 sold in China. All recovered, unused products from the implicated batch were subsequently destroyed to prevent further distribution and mitigate potential health hazards associated with the contaminated medical devices.