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

Source: https://www.globalkeysolutions.net/records/china_product_recall/advanced-sterilization/b0330553-4ae9-445d-b869-1b169480b0b9/
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. initiated a voluntary Level II recall for its

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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: An internal evaluation of a specific model of hydrogen peroxide low-temperature plasma sterilization system by the parent company revealed a series of highly incidental events. 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 H₂O and causing injury.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Advanced Sterilization
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Level II recall for its hydrogen peroxide low-temperature plasma sterilization system, affecting models including 10033. The recall was publicly reported on February 21, 2017, following an internal evaluation that revealed a critical safety issue. The primary concern is that after an external power outage, the system's door lock may loosen for approximately 20 seconds during restart. This temporary malfunction could expose users to a potentially harmful concentration of hydrogen peroxide, leading to injury. While no related complaints or adverse events have been reported in China to date, the company has identified this as a highly incidental event. The recall encompasses all batch numbers for 350 imported units, with 339 units sold in China. Operating under the regulatory oversight of the National Medical Products Administration (NMPA), formerly CFDA, Johnson & Johnson's required actions involve notifying all affected customers about the recall and emphasizing the crucial need to strictly adhere to the instruction manual during product operation to mitigate risks. This proactive measure aims to ensure user safety and compliance with medical device regulations in China.

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