# China NMPA Product Recall - Medical cotton balls

Source: https://www.globalkeysolutions.net/records/china_product_recall/yixin-medical-devices-co-ltd/31cf9b5b-c67c-45bc-86d6-47e83ae3fc92/
Source feed: China

> China NMPA product recall for Medical cotton balls by Yixin Medical Devices Co., Ltd. published October 11, 2019. Recall level: Level 3 Recall. Yixin Medical Devices Co., Ltd., operating under the regulatory authority of the National Medical Pr

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Yixin Medical Devices Co., Ltd. voluntarily recalls medical cotton balls
- Company Name: Yixin Medical Devices Co., Ltd.
- Publication Date: 2019-10-11
- Product Name: Medical cotton balls
- Recall Level: Level 3 Recall
- Recall Reason: pH level not up to standard
- Discovering Company: Yixin Medical Devices Co., Ltd.
- Manufacturing Company: Yixin Medical Devices Co., Ltd.
- Summary: Yixin Medical Devices Co., Ltd., operating under the regulatory authority of the National Medical Products Administration (NMPA), voluntarily initiated a Level III recall for a specific batch of its medical cotton balls. This action, publicly reported on October 11, 2019 (Index Number: JGXX-2019-10642), was necessitated by the identification of substandard pH levels within these products. The company itself reported this quality deficiency, indicating a proactive approach to product safety and compliance. The core issue revolved around the pH balance of the medical cotton balls, a critical quality parameter for products intended for medical use and direct contact with patients. A Level III recall, as designated by regulatory standards, signifies that exposure to the defective product is unlikely to cause adverse health consequences for consumers. However, it still mandates the removal of the non-compliant items from distribution and use to uphold established quality benchmarks. The NMPA's announcement confirms Yixin Medical Devices Co., Ltd.'s commitment to addressing the identified issue by implementing the required corrective action. Further specifics regarding the affected models, specifications, and batch numbers are documented in the "Medical Device Recall Event Report Form," an essential component of the recall process. This incident highlights the robust regulatory oversight by the NMPA to ensure medical device quality, even for issues that present a minimal health risk, reinforcing public trust in medical products.

Company: https://www.globalkeysolutions.net/companies/yixin-medical-devices-co-ltd/8eacb3b1-c0d5-40ce-b1d4-f165ae0ff001/