China NMPA Product Recall - One hemodialysis session concentrated Han

Nanjing Haibo Medical Device Co., Ltd. initiated a voluntary Class III recall of its single-use hemodialysis concentrate (Chinese version), identified by National Medical Device Registration Certificate 20173450103. This action, reported on March 26, 2020, through the Jiangsu Provincial Drug Administration Website and overseen by the National Medical Products Administration (NMPA), stemmed from a significant quality issue. The main violation was the product's failure to meet standard requirements for fill volume, a critical parameter for patient safety and treatment effectiveness. This non-compliance was originally discovered during the 2019 national medical device sampling inspection. As part of the required actions, detailed information regarding the specific models, specifications, and batch numbers of the affected products is documented in a "Medical Device Recall Event Report Form." This voluntary recall underscores the company's adherence to regulatory standards set by the NMPA and its commitment to ensuring the quality and safety of medical devices in the market.