China NMPA Product Recall - Vascular sheath group

Terumo Corporation initiated a voluntary Class II recall of its vascular sheath kits (Registered No.: 20143773235), as reported by Terumo (China) Investment Co., Ltd. to the National Medical Products Administration (NMPA). This action stemmed from a discovery during a routine factory inspection, which revealed potential damage to the product packaging integrity, posing a risk to product sterility. The recall, detailed in a report dated May 26, 2017, affects 211,460 units imported into China and distributed globally, under the regulatory oversight of the NMPA (formerly CFDA) for imported medical devices. As required actions, Terumo has directed distributors to list and provide feedback on any recalled batches already used in hospitals. Furthermore, all affected products sold but not yet used by distributors, resellers, or hospitals must be recalled and subsequently destroyed. Terumo confirmed that no customer complaints or patient injuries related to this packaging issue have been reported, emphasizing this as a proactive measure to safeguard patient safety.