China NMPA Product Recall - Retrievable vena cava filter

Cordis Cashel, an Irish manufacturer, initiated a voluntary recall of its OptEase Retrievable Inferior Vena Cava Filters (Registration No.: 20113771119(Revised)). This action, reported by its Chinese responsible unit, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., was publicly announced by China's National Medical Products Administration (NMPA) on November 7, 2013, following an internal report dated October 21, 2013. The recall impacts products with batch number 15960131 and earlier. The primary issue identified was an incorrect printing direction for the femoral vein access arrow on the device. This critical error could lead to the filter being implanted upside down, which would necessitate an additional percutaneous surgical removal procedure. Given the potential for similar undetected printing defects, the recall was extended broadly to affected batches. A total of 11,096 units were imported into China, with 10,231 units having been sold. Under the regulatory framework of the NMPA and provincial Food and Drug Administrations, required actions include immediately stopping shipment and isolating affected products. Distributors and users must be notified to return all unused affected products to Johnson & Johnson warehouses for return to the manufacturer or local destruction, mitigating potential patient risks.