China NMPA Product Recall - Disposable hollow fiber high-flux dialyzer

Jiangsu Langsheng Life Technology Co., Ltd. initiated a voluntary Class III recall of its Disposable Hollow Fiber High-Fluidity Dialyzers (Model LSHT180-A, Batch 1809034). This action was formally reported to the National Medical Products Administration (NMPA) on November 2, 2018. The recall became necessary due to reports of adverse patient reactions, specifically hypotension, experienced during the use of these devices in a Guangzhou hospital, indicating a critical product safety concern. The affected batch comprised 1283 units produced, with 763 units having been sold within China. Under the NMPA's regulatory guidance, Jiangsu Langsheng Life Technology Co., Ltd. mandated several corrective actions. All user facilities, including hospitals, were instructed to immediately cease using the implicated batch of dialyzers. Furthermore, all existing inventory of the affected products (batch 1809034) must be returned to the manufacturer. The company is responsible for retesting these returned devices and processing them appropriately based on the test results, ensuring the removal of potentially unsafe products from the market and safeguarding patient well-being.