# China NMPA Product Recall - Cleaning and sterilizing equipment

Source: https://www.globalkeysolutions.net/records/china_product_recall/maikewei-shanghai-medical-equipment-co-ltd/4cfed22d-ee73-4fbd-8e91-a4624f8824cc/
Source feed: China

> China NMPA product recall for Cleaning and sterilizing equipment by Maikewei (Shanghai) Medical Equipment Co., Ltd. published October 29, 2020. Recall level: Level 3 Recall. Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class III recall on October 29

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Maikewei (Shanghai) Medical Equipment Co., Ltd. has voluntarily recalled its cleaning and sterilizing equipment.
- Company Name: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Publication Date: 2020-10-29
- Product Name: Cleaning and sterilizing equipment
- Recall Level: Level 3 Recall
- Recall Reason: Some cleaning and disinfection equipment shipped to the Chinese market did not use the system software serial number for the Chinese market.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Summary: Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class III recall on October 29, 2020, for certain cleaning and sterilizing devices distributed in the Chinese market. The recall, overseen by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, was prompted by the discovery that some units were equipped with system software numbers not designated for the Chinese market. This issue affected devices registered under certificate number 国械注进20152573009. To address the non-compliance, Maikewei (Shanghai) Medical Equipment Co., Ltd. is undertaking corrective actions to update the system software on all affected cleaning and sterilizing devices to the appropriate and latest version approved for the Chinese market. Detailed information regarding the specific models, specifications, and batches involved in the recall is available in the accompanying Medical Device Recall Event Report Form.

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