China NMPA Product Recall - Concentrates for hemodialysis and related treatments

Shanghai Heting Trading Co., Ltd. initiated a voluntary Class III recall of its hemodialysis and related therapeutic concentrates. This action, reported by the National Medical Products Administration (NMPA) on October 28, 2021, stems from a critical manufacturing issue identified within the company's operations. The primary violation involved the failure to promptly address and rectify malfunctions in the production water pipeline over an extended period, specifically from August 16, 2020, to July 30, 2021. As a result of this lapse in quality control, Shanghai Heting Trading Co., Ltd. determined it necessary to recall all affected products manufactured during the specified timeframe. The recall encompasses hemodialysis and related therapeutic concentrates, identified by Registration Certificate No.: 20163451474. The company's decision to conduct a voluntary Level III recall underscores the seriousness of the issue. Further details regarding specific product models, specifications, and batch numbers are available in the "Medical Device Recall Event Report Form" attachment referenced by the NMPA. This incident highlights the importance of rigorous adherence to manufacturing process integrity under the NMPA's oversight.