# 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/7107f21a-21cc-4cb6-b51f-0a65649c00ce/
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 Recall. Hebi Zhongxing Medical Supplies Co., Ltd. initiated a voluntary Class III recall for a specific batc

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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
- 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. initiated a voluntary Class III recall for a specific batch of its disposable human venous blood sampling containers. The recall was prompted by the discovery that the sterility of these medical devices did not meet required standards. The affected products include the Heparin Sodium 5 model, specifically from lot 20170616. This issue posed a potential risk as sterility is critical for devices used in blood sampling, directly impacting patient safety and the reliability of medical procedures.

The action was formally reported and published by the National Medical Products Administration (NMPA) on October 21, 2017. A Class III recall indicates that the product is unlikely to cause adverse health consequences but violates NMPA regulations. As a voluntary action, Hebi Zhongxing Medical Supplies Co., Ltd. took responsibility for identifying the non-conformance and withdrawing the compromised products from circulation. The company was required to submit a "Medical Device Recall Event Report Form" detailing the specifics of the event and their corrective actions to ensure compliance with the NMPA's medical device oversight framework. The recall aimed to mitigate any potential health risks associated with the non-sterile devices and uphold product quality standards.

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