China NMPA Product Recall - Hemodialysis filter

Bellerek Hexiang Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its hemodialysis filters (Registration Certificate No.: CFDA (Imported) 2014 No. 3451955 (Revised)). This action followed a medical device sampling inspection where in vitro test results revealed a critical quality issue: the measured value of Vitamin B12 in the filters exceeded the acceptable tolerance range of -o-u-t-l-i-n-e-s