# China NMPA Product Recall - Pressure steam sterilizer

Source: https://www.globalkeysolutions.net/records/china_product_recall/getinge-sterilization-ab/962e63dc-f913-4583-be1b-510ef9d7ec67/
Source feed: China

> China NMPA product recall for Pressure steam sterilizer by Getinge Sterilization AB published February 14, 2020. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) has announced a Class II voluntary recall initia

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Getinge Sterilization AB initiates proactive recall of pressure steam sterilizers.
- Company Name: Getinge Sterilization AB
- Publication Date: 2020-02-14
- Product Name: Pressure steam sterilizer
- Recall Level: Level 2 Recall
- Recall Reason: Certain models and batches of vacuum pumps may leak water, potentially causing electrical leakage.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: Getinge Sterilization AB
- Summary: The National Medical Products Administration (NMPA) has announced a Class II voluntary recall initiated by Getinge Sterilization AB, with Maikewei (Shanghai) Medical Equipment Co., Ltd. reporting the issue on behalf of the manufacturer. The recall, published on February 14, 2020, pertains to specific models and batches of Getinge's steam sterilizers. The primary issue identified is a potential defect within the vacuum pumps of these sterilizers, posing a risk of leakage that could lead to electrical leakage. This defect presents a safety concern for users and patients, necessitating immediate corrective action. The regulatory framework for this action is the NMPA's medical device recall process in China. A Class II recall signifies that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Getinge Sterilization AB is undertaking a voluntary recall to address the identified vacuum pump defect and mitigate potential electrical leakage risks. The company is required to follow NMPA recall procedures, providing detailed information on affected products in a "Medical Device Recall Event Report Form" to ensure proper identification and removal of non-conforming devices from circulation. No specific inspection dates were mentioned in the provided document.

Company: https://www.globalkeysolutions.net/companies/getinge-sterilization-ab/7e0cd868-6669-4b2a-a346-22a9c42d803f/