# China NMPA Product Recall - sterilizer

Source: https://www.globalkeysolutions.net/records/china_product_recall/maikewei-shanghai-medical-equipment-co-ltd/8f0acc97-6cf8-472c-9c71-25248b76c4c7/
Source feed: China

> China NMPA product recall for sterilizer by Maikewei (Shanghai) Medical Equipment Co., Ltd. published October 20, 2020. Recall level: Level 3 Recall. On October 20, 2020, Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class III

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Maikewei (Shanghai) Medical Equipment Co., Ltd. has initiated a voluntary recall of sterilizers.
- Company Name: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Publication Date: 2020-10-20
- Product Name: sterilizer
- Recall Level: Level 3 Recall
- Recall Reason: Chinese label serial number error
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Summary: On October 20, 2020, Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class III recall for its HS6617 model sterilizers. The company discovered incorrect serial numbers on the Chinese labels of two specific sterilizer units, prompting this action out of responsibility to its customers. The recall is overseen by the National Medical Products Administration (NMPA), the regulatory body in China. A Class III recall indicates that use of, or exposure to, the affected product is not likely to cause adverse health consequences. The required action involves the retrieval of these mislabeled sterilizers from the market, with detailed information on affected product models, specifications, and serial numbers available in a "Medical Device Recall Event Report Form" provided by the company. This self-initiated recall demonstrates the company's proactive approach to product quality and regulatory compliance.

Company: https://www.globalkeysolutions.net/companies/maikewei-shanghai-medical-equipment-co-ltd/77310e7c-a692-4918-a052-23f3348af2e9/