China NMPA Product Recall - Hollow fiber dialysis machine

Toray Medical Technology (Qingdao) Co., Ltd., acting as the agent for manufacturer Toray Industries, Inc., announced a voluntary Class III recall of its imported Hollow Fiber Dialyzers. This recall, reported by the National Medical Products Administration (NMPA) on May 17, 2019, addresses a significant quality concern. The primary issue prompting the recall was the identification of non-polymethyl methacrylate (PMMA) raw material contamination within the PMMA used for manufacturing the hollow fiber dialyzers. This contamination risk was discovered during an analysis of defective products encountered in the production process. Despite affected products having passed both internal process and final product inspections, Toray initiated the recall as a precautionary measure to ensure patient safety. The recall impacts specific batches and models of the dialyzers, totaling tens of thousands of units intended for patients with acute and chronic renal failure. Under the NMPA's regulatory framework, the required actions for affected parties include immediately ceasing the use of the recalled products upon notification. Furthermore, all retrieved recalled units are to be securely stored in a warehouse and subsequently disposed of following proper verification procedures.