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

Source: https://www.globalkeysolutions.net/records/china_product_recall/advanced-sterilization/e3e223af-cfa3-442c-aab7-a311cac20913/
Source feed: China

> China NMPA product recall for Hydrogen peroxide low-temperature plasma sterilization system by Advanced Sterilization published February 21, 2017. Recall level: Level II. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., operating under the regulatory framework of 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling its hydrogen peroxide low-temperature plasma sterilization system.
- Company Name: Advanced Sterilization
- Publication Date: 2017-02-21
- Product Name: Hydrogen peroxide low-temperature plasma sterilization system
- Recall Level: Level II
- Recall Reason: The parent company discovered a series of highly incidental events during an internal evaluation of a specific model of its hydrogen peroxide low-temperature plasma sterilization system. Following an external power outage, the system's door lock may have loosened for 20 seconds during system restart, potentially exposing users to a concentration of H₂O₂ and causing injury. To date, no related complaints or adverse events have been reported in China.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Advanced Sterilization
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/advanced-sterilization/867b38a5-f105-47d6-a56a-86b283489473/