# China NMPA Product Recall - One hemodialysis session concentrated Han

Source: https://www.globalkeysolutions.net/records/china_product_recall/nanjing-haibo-medical-equipment-co-ltd/0f891323-7e38-4f23-ae07-8485903896b3/
Source feed: China

> China NMPA product recall for One hemodialysis session concentrated Han by Nanjing Haibo Medical Equipment Co., Ltd. published March 26, 2020. Recall level: Level 3 Recall. Nanjing Haibo Medical Device Co., Ltd. initiated a voluntary Class III recall of its single-use hemo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Nanjing Haibo Medical Devices Co., Ltd. voluntarily recalls hemodialysis concentrate from its parent company.
- Company Name: Nanjing Haibo Medical Equipment Co., Ltd.
- Publication Date: 2020-03-26
- Product Name: One hemodialysis session concentrated Han
- Recall Level: Level 3 Recall
- Recall Reason: The filling volume failed to meet the standard requirements.
- Discovering Company: Nanjing Haibo Medical Equipment Co., Ltd.
- Manufacturing Company: Nanjing Haibo Medical Equipment Co., Ltd.
- Summary: Nanjing Haibo Medical Device Co., Ltd. initiated a voluntary Class III recall of its single-use hemodialysis concentrate (Chinese version), identified by National Medical Device Registration Certificate 20173450103. This action, reported on March 26, 2020, through the Jiangsu Provincial Drug Administration Website and overseen by the National Medical Products Administration (NMPA), stemmed from a significant quality issue. The main violation was the product's failure to meet standard requirements for fill volume, a critical parameter for patient safety and treatment effectiveness. This non-compliance was originally discovered during the 2019 national medical device sampling inspection. As part of the required actions, detailed information regarding the specific models, specifications, and batch numbers of the affected products is documented in a "Medical Device Recall Event Report Form." This voluntary recall underscores the company's adherence to regulatory standards set by the NMPA and its commitment to ensuring the quality and safety of medical devices in the market.

Company: https://www.globalkeysolutions.net/companies/nanjing-haibo-medical-equipment-co-ltd/6b03c056-1938-4cd8-923e-7cca0d274a9e/