China NMPA Product Recall - Hydrogen peroxide low-temperature plasma sterilization system

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Level II recall for its Hydrogen Peroxide Low-Temperature Plasma Sterilization System (Model 10033). This action was reported on January 17, 2017, and publicly announced on March 1, 2017, under the oversight of the National Medical Products Administration (NMPA). The recall stems from an internal evaluation revealing a potential safety concern: following an external power outage, the system's door lock might temporarily loosen for approximately 20 seconds during restart. This defect could expose users to a hazardous concentration of hydrogen peroxide, posing a risk of injury. While 350 units were imported and 339 sold in China, no related complaints or adverse events have been reported within the country. As required actions, Johnson & Johnson is notifying all affected customers about the recall. Additionally, users are being reminded to meticulously adhere to the instruction manual during the operation of these sterilization systems to mitigate any potential risks.