China NMPA Product Recall - hemodialysis machine

Beierke Hexiang Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its hemodialyzers, model BLS816SD, impacting 3360 units distributed in Suzhou, Shanghai, and Guangzhou. The recall was reported to the National Medical Products Administration (NMPA) on January 13, 2017, and publicly announced on February 21, 2017. The primary issue identified was an incorrect registration certificate number printed on the Chinese labels of the affected products. This labeling discrepancy pertained to the product's official registration certificate, Quốc Kieu note into 20163452798, on the packaging. As the responsible unit in China for manufacturer Bellco S.i.l., Beierke Hexiang implemented a clear corrective action plan. This plan requires relevant sales teams and distributors to issue notification letters to customers. Following this, customers and distributors must return the identified batches of hemodialyzers to Beierke Hexiang, which will then replace the units with correctly labeled products to ensure regulatory compliance.