China NMPA Product Recall - Hemodialysis device

The National Medical Products Administration (NMPA) announced a voluntary Level II recall initiated by Baxter Medical Products Trading (Shanghai) Co., Ltd., with the announcement published on December 11, 2020. This action addresses safety concerns related to various hemodialysis devices, equipment, and systems. The recall was prompted by two safety incidents reported in Baxter Canada over the preceding two years, where product leakage occurred due to the use of additional connectors between hemodialysis tubing and catheters. While no specific inspection dates are provided, the recall’s timeline is anchored by the publication date and the two-year period for incident reports. Under the NMPA's regulatory framework for medical devices, Baxter is voluntarily recalling the affected products to ensure patient safety and product integrity. The required action involves the retrieval of the identified hazardous products from the market. Specific details regarding affected models, specifications, and batch numbers are outlined in a separate Medical Device Recall Event Report Form.