China NMPA Product Recall - U9000 Ultrafilter

Baxter Medical Products Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its U9000 ultrafilters due to significant leakage issues identified during clinical use. This action, reported by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration on August 1, 2019, follows an Emergency Medical Device Corrective Communication (EMC) issued by Baxter on April 9, 2018, regarding the safety concern.

The primary issue involved the U9000 ultrafilter experiencing leaks when utilized with AK96 or AK98 v1 dialysis machines. To mitigate potential patient risks, Baxter implemented several critical corrective actions. The maximum service life for the affected ultrafilters was significantly reduced to 60 days or 100 sterilization cycles, with specific limitations on sodium carbonate (8 cycles) and sodium hypochlorite (12 cycles) sterilizations.

Furthermore, Baxter committed to updating user manuals for clarity on proper usage and maintenance, and resetting disinfection counters on the AK96 and AK98 v1 hemodialysis machines to ensure adherence to new service life guidelines. The company also provided renewed customer letters with additional guidance on weekly disinfection procedures. This comprehensive response aims to enhance patient safety by addressing the identified product deficiencies under the oversight of the NMPA.