China NMPA Product Recall - Disposable hollow fiber hemodialysis machine

The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Jiangsu Langsheng Life Technology Co., Ltd., published on November 21, 2017, following a report dated November 2, 2017. This recall involves their disposable hollow fiber hemodialysis machines (Registration No.: 20153450480, Model LST160-A, Batch 1708053), with 6996 units distributed across China. The primary justification for this action arose from reports of adverse events, specifically encompassing issues such as tube blockage, membrane rupture, and leakage, which were identified in various operational regions. In response to these significant safety concerns, Jiangsu Langsheng Life Technology Co., Ltd. enacted several corrective measures under the NMPA's regulatory framework. User units were promptly instructed to discontinue the use of the affected batch. Additionally, all existing product inventory from batch 1708053 was required to be returned to the manufacturer. The company committed to retesting all returned products and processing them according to the outcomes of these tests, demonstrating a commitment to patient safety and product quality.