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

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., operating under the regulatory framework of the National Medical Products Administration (NMPA) in China, initiated a voluntary Level II recall for specific models of its hydrogen peroxide low-temperature plasma sterilization system. This critical medical device is designed for sterilizing instruments to ensure a high sterility assurance level. The recall, reported on January 17, 2017, addresses a significant safety issue identified during the company's internal evaluation: after an external power outage, the system's door lock, specifically for Model 10033, may loosen for up to 20 seconds during restart. This defect presents a potential risk of exposing users to a harmful concentration of hydrogen peroxide, which could lead to injury. Approximately 350 units were imported to China, with 339 units already sold. While no related complaints or adverse events have been reported in China, the company is taking proactive measures. Required actions include notifying all affected customers about the recall and emphasizing the critical importance of strictly adhering to the product's instruction manual during operation. This ensures ongoing compliance with medical device safety standards and prioritizes user safety.