China NMPA Product Recall - Hemodialysis filtration device

Bellec Medical Equipment (Shanghai) Co., Ltd., on behalf of manufacturer Bellco S.i.l., initiated a voluntary Class II recall of its Hemodialysis Filtration Devices, specifically models FORMULA, FORMULA2000, and FORMULA THERAPY 2422, as reported by the National Medical Products Administration (NMPA) on December 29, 2016. The recall stems from three global incidents where accidental liquid spillage on the backup battery charging board led to short-circuiting, overheating, and subsequent machine fires. These events posed a significant safety risk to patients undergoing dialysis therapy. To address these critical issues, Bellec Medical Equipment (Shanghai) Co., Ltd. has outlined several corrective actions. These include sales teams and distributors ensuring the delivery of recall notifications to affected facilities. Furthermore, trained technicians are mandated to conduct on-site testing of the backup power systems for all units in China. If any faults are identified, the battery charging board must be replaced promptly. The company also committed to launching comprehensive warnings and public awareness campaigns to inform users about the potential hazards and the necessary precautions. This proactive recall demonstrates the company's commitment to patient safety and product reliability under the NMPA's regulatory oversight.