China NMPA Product Recall - NextStep Antegrade/Simplicity™ Hemodialysis Catheter Kit

The National Medical Products Administration (NMPA) announced a voluntary recall initiated by Arrow International Inc. for specific batches of its NextStep Antegrade/Simplicity™ Hemodialysis Catheter Kits. The manufacturer, Arrow International Inc., based in Reading, Pennsylvania, undertook this action following complaints of catheter core breakage or separation. These catheters are vital for long-term hemodialysis in adult patients, typically placed in a large neck vein. Although the recall, published on September 9, 2011, affects models such as CS-15192-IXM through CS-15502-IX and various batch numbers, Arrow confirmed these specific recalled products were not registered, imported, or sold within the Chinese market. Nevertheless, the NMPA mandated that all provincial food and drug administrations strengthen their oversight of similar medical devices to ensure public safety. For customers in affected regions outside China, the required actions included immediately inspecting existing inventory, halting the use and distribution of identified products, and promptly contacting Arrow customer service for guidance. Talifu Medical Devices Trading (Shanghai) Co., Ltd. facilitated the recall reporting to the NMPA.