China NMPA Product Recall - Sterilization bag rolls of hydrogen peroxide low-temperature plasma sterilization system

Advanced Sterilization Products, Inc., in collaboration with Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary recall for specific sterilization bag rolls designed for hydrogen peroxide low-temperature plasma sterilization systems. This recall was formally reported on April 23, 2014, and published by the National Medical Products Administration (NMPA) on May 4, 2014. The core issue stemmed from an incorrect expiration date printed on the packaging labels of two batches (12332 and 12326) of the sterilization bag rolls, which mistakenly displayed the production date instead of the actual expiration date. Despite the labeling error, the company stated that patient safety was not compromised, as product instructions direct users to discard expired items. Regulatory oversight was provided by the NMPA and regional Food and Drug Administrations. Notably, none of the affected products were imported into or distributed within China. As a result, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. reported the matter to the State Food and Drug Administration but did not implement further corrective actions or submit additional reports within China due to the absence of affected inventory. Regional regulatory bodies were advised to enhance supervision of similar products.