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

Source: https://www.globalkeysolutions.net/records/china_product_recall/advanced-sterilization/49b3f74a-e254-4d6e-b9fa-12eb0ac2777e/
Source feed: China

> China NMPA product recall for Hydrogen peroxide low-temperature plasma sterilization system by Advanced Sterilization published March 01, 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: 2017-03-01
- 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 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.
- 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 (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.

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