# China NMPA Product Recall - Cleaning and sterilizing equipment

Source: https://www.globalkeysolutions.net/records/china_product_recall/maikewei-shanghai-medical-equipment-co-ltd/2f53ce6c-e963-4225-b6e2-5f3ae0d5250f/
Source feed: China

> China NMPA product recall for Cleaning and sterilizing equipment by Maikewei (Shanghai) Medical Equipment Co., Ltd. published January 19, 2020. Recall level: Level 2 Recall. Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a Class II voluntary recall of certain cle

---

## 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: 2020-01-19
- Product Name: Cleaning and sterilizing equipment
- Recall Level: Level 2 Recall
- Recall Reason: Cracks may appear at the weld points inside the cavity, leading to leaks, which could cause inconvenience to users, delays in the cleaning process, or installation delays.
- 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 Class II voluntary recall of certain cleaning and sterilizing devices (model 88-5) following the manufacturer's discovery of a critical product issue. The recall, publicly announced on January 19, 2020, through the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, addresses devices produced before November 2012. The primary defect identified involves cracked solder joints within the chamber of the affected units. This structural compromise could lead to leakage, which in turn might cause significant inconvenience for users and disrupt or delay essential cleaning and sterilization processes. While these issues have the potential to impact operational efficiency, Maikewei (Shanghai) Medical Equipment Co., Ltd. has confirmed that no injury incidents related to this defect have been reported. Under the guidance of the NMPA, the company is taking proactive measures to manage this situation. The required action involves the comprehensive voluntary recall of all identified affected cleaning and disinfection equipment, as detailed in the "Medical Device Recall Event Report Form" (Registration Certificate No.: CFDA (Imported) 2012 No. 2570864). This action underscores the company's commitment to product safety and compliance with regulatory standards.

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