# China NMPA Product Recall - Cleaning and sterilizing equipment

Source: https://www.globalkeysolutions.net/records/china_product_recall/maikewei-shanghai-medical-equipment-co-ltd/6f855898-fe2e-409b-a1c6-cdfa2c666d48/
Source feed: China

> China NMPA product recall for Cleaning and sterilizing equipment by Maikewei (Shanghai) Medical Equipment Co., Ltd. published April 29, 2019. Recall level: Level 2 Recall. Maikewei (Shanghai) Medical Equipment Co., Ltd. has initiated a voluntary Class II recall for specif

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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: 2019-04-29
- Product Name: Cleaning and sterilizing equipment
- Recall Level: Level 2 Recall
- Recall Reason: The pump hoses of some cleaning and sterilizing devices with models S-8666 and S-8668 may deform during the cleaning process, which may result in poor cleaning effect after the cleaning process is completed.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Summary: Maikewei (Shanghai) Medical Equipment Co., Ltd. has initiated a voluntary Class II recall for specific models of its cleaning and sterilizing devices, namely S-8666 and S-8668. The recall, published on April 29, 2019, by the National Medical Products Administration (NMPA), was prompted by the manufacturer's discovery that the pump hose in certain units may deform during the cleaning process. This deformation could lead to a compromised cleaning effect, potentially impacting device hygiene and user safety. The company, operating under NMPA's regulatory framework (Medical Device Registration Certificate No. 20152573009), proactively identified this issue to ensure product safety and customer confidence, even though no complaints or adverse event reports related to this defect have been received. Maikewei (Shanghai) Medical Equipment Co., Ltd. is taking necessary action to address this performance concern. Customers are directed to the "Medical Device Recall Event Report Form" for detailed information regarding the specific product models, specifications, and batches involved in this recall.

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