# China NMPA Product Recall - Medical cotton balls

Source: https://www.globalkeysolutions.net/records/china_product_recall/xinxiang-huaxi-medical-supplies-co-ltd/712700cc-4c5d-4be2-a5e4-0309cd32963e/
Source feed: China

> China NMPA product recall for Medical cotton balls by Xinxiang Huaxi Medical Supplies Co., Ltd. published October 11, 2019. Recall level: Level 3 Recall. On October 11, 2019, Xinxiang Huakang Medical Supplies Co., Ltd. initiated a voluntary Class III rec

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Xinxiang Huakang Medical Supplies Co., Ltd. has voluntarily recalled its medical cotton balls.
- Company Name: Xinxiang Huaxi Medical Supplies Co., Ltd.
- Publication Date: 2019-10-11
- Product Name: Medical cotton balls
- Recall Level: Level 3 Recall
- Recall Reason: A batch of medical cotton balls failed to meet the required standards for surfactant content.
- Discovering Company: Xinxiang Huakang Medical Supplies Co., Ltd.
- Manufacturing Company: Xinxiang Huaxi Medical Supplies Co., Ltd.
- Summary: On October 11, 2019, Xinxiang Huakang Medical Supplies Co., Ltd. initiated a voluntary Class III recall for specific batches of its medical cotton balls. This action was prompted by the discovery of non-compliance with established regulatory standards concerning the presence of surfactants within the product. Surfactants, while commonly used, must meet stringent guidelines when incorporated into medical devices to ensure both patient safety and product effectiveness. The regulatory oversight for this recall is provided by the National Medical Products Administration (NMPA), the primary governing body for medical devices and products in China. The company's decision to voluntarily recall the affected items demonstrates a responsive approach to identified quality concerns. Details concerning the exact models, specifications, and batch numbers of the medical cotton balls subject to recall are thoroughly documented in the accompanying 'Medical Device Recall Event Report Form.' The NMPA's public disclosure of this recall emphasizes the importance of regulatory adherence and transparency in safeguarding public health, ensuring that healthcare providers and consumers are well-informed about potential product issues and the corrective measures undertaken by manufacturers.

Company: https://www.globalkeysolutions.net/companies/xinxiang-huaxi-medical-supplies-co-ltd/58c01494-7dcb-4cd8-aa4b-7df2597c9f13/