# China NMPA Product Recall - Disposable human venous blood collection container

Source: https://www.globalkeysolutions.net/records/china_product_recall/hebi-zhongxing-medical-supplies-co-ltd/6b821e26-abc9-4de2-b946-c0f0512031b6/
Source feed: China

> China NMPA product recall for Disposable human venous blood collection container by Hebi Zhongxing Medical Supplies Co., Ltd. published October 21, 2017. Recall level: Level 3. Hebi Zhongxing Medical Supplies Co., Ltd. has initiated a voluntary recall of a specific batch of it

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Hebi Zhongxing Medical Supplies Co., Ltd. has voluntarily recalled its disposable human venous blood collection containers.
- Company Name: Hebi Zhongxing Medical Supplies Co., Ltd.
- Publication Date: 2017-10-21
- Product Name: Disposable human venous blood collection container
- Recall Level: Level 3
- Recall Reason: The sterility of the test item did not meet the standard requirements.
- Discovering Company: Hebi Zhongxing Medical Supplies Co., Ltd.
- Manufacturing Company: Hebi Zhongxing Medical Supplies Co., Ltd.
- Summary: Hebi Zhongxing Medical Supplies Co., Ltd. has initiated a voluntary recall of a specific batch of its disposable human venous blood sampling containers. The recall, publicly reported on October 21, 2017, stems from the discovery that the sterility of these medical devices did not conform to established quality standards. The affected products are identified as heparin sodium 5ml, from batch number 20170616. Inspection dates are not specified in this recall notice. This voluntary action by Hebi Zhongxing Medical Supplies Co., Ltd. is categorized as a Level III recall, indicating that the use of or exposure to a violative product is not likely to cause adverse health consequences. The regulatory oversight for this recall falls under the purview of the National Medical Products Administration (NMPA), the governmental body responsible for regulating medical devices. The primary required action for the company is the immediate and complete retrieval of all affected units from circulation to mitigate any potential, albeit low-risk, health implications associated with non-sterile blood sampling containers. Further details regarding the recall event are referenced in an attached Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/hebi-zhongxing-medical-supplies-co-ltd/1a62ff61-ac71-460e-96c0-66e2fe8f82ea/