China NMPA Product Recall - Abdominal aortic aneurysm stent system

The National Medical Products Administration (NMPA) issued a recall notice on July 31, 2017, concerning a voluntary Level III recall of the Abdominal Aortic Aneurysm Stent System by manufacturer Cordis Cashel. Cordis (Shanghai) Medical Devices Co., Ltd., the distributor, reported the recall, which arose because products from five newly established production sites had not yet secured the necessary CE certification. The primary issue involved the inadvertent shipment of five non-CE certified stents, from three specific models (L1612, IL1308, IL1614) and batches, to three hospitals located in Italy and Switzerland. Notably, no affected products were imported or distributed within China. The regulatory framework mandates immediate corrective action. The manufacturer is required to contact the involved hospitals to retrieve the non-compliant products and replace them with fully certified stent systems manufactured at the originally approved production locations. This action ensures adherence to product safety and certification standards.