China NMPA Product Recall - Vascular sheath group

Terumo Corporation, a medical device manufacturer, initiated a voluntary Class II recall of its vascular sheath kits globally, impacting 211,460 units distributed in China. The recall, formally reported on May 26, 2017, and subsequently published by the National Medical Products Administration (NMPA) on June 14, 2017, arose from findings during a routine factory inspection. This inspection revealed potential damage to the product packaging integrity, which could compromise the sterility of the kits. These devices are critical for interventional procedures, facilitating the insertion of catheters, electrodes, and other instruments. Under the regulatory framework of the NMPA (formerly CFDA for imported medical devices), Terumo (China) Investment Co., Ltd. is undertaking specific corrective actions. Distributors, resellers, and hospitals are mandated to recall and destroy all affected product batches that have been sold but are currently unused. For units already utilized in clinical settings, distributors must compile a comprehensive list and provide feedback to Terumo. Importantly, at the time of the report, no customer complaints or patient injuries linked to this packaging issue had been received, indicating a proactive safety measure.