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

Source: https://www.globalkeysolutions.net/records/china_product_recall/advanced-sterilization/3609f60f-c0db-470b-bd83-b11c38c0d8c4/
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 spe

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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. initiated a voluntary Level II recall for specific models of its Hydrogen Peroxide Low-Temperature Plasma Sterilization Systems, particularly model 10033. This action, reported to the National Medical Products Administration (NMPA) on January 17, 2017, and published on February 21, 2017, arose from an internal evaluation by the parent company. The core safety issue identified is that after an external power outage, the system's door lock might temporarily loosen for 20 seconds during restart. This momentary vulnerability could potentially expose users to a hazardous concentration of hydrogen peroxide, posing a risk of injury. Of the 350 units imported into China, 339 had been sold; however, no related complaints or adverse events have been reported in China to date. Under the NMPA's regulatory framework, the company's required corrective 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 to ensure user safety.

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