# China NMPA Product Recall - Disposable medical cotton swabs

Source: https://www.globalkeysolutions.net/records/china_product_recall/kunming-kangye-medical-equipment-co-ltd/ee1afb1f-3cb8-42fc-8c3b-93c0d5c6ef09/
Source feed: China

> China NMPA product recall for Disposable medical cotton swabs by Kunming Kangye Medical Equipment Co., Ltd. published September 27, 2021. Recall level: Level 3. Kunming Kangye Medical Device Co., Ltd. has initiated a voluntary Level III recall of its disposable

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Kunming Kangye Medical Devices Co., Ltd. voluntarily recalls disposable medical cotton swabs.
- Company Name: Kunming Kangye Medical Equipment Co., Ltd.
- Publication Date: 2021-09-27
- Product Name: Disposable medical cotton swabs
- Recall Level: Level 3
- Recall Reason: Non-compliance with standard requirements (non-compliant bacteria)
- Discovering Company: Kunming Kangye Medical Equipment Co., Ltd.
- Manufacturing Company: Kunming Kangye Medical Equipment Co., Ltd.
- Summary: Kunming Kangye Medical Device Co., Ltd. has initiated a voluntary Level III recall of its disposable medical swabs following a random inspection by the Yunnan Provincial Drug Administration. This regulatory action, overseen by the National Medical Products Administration (NMPA), was prompted by a critical compliance failure: the presence of bacteria in the product. This finding indicates a significant deviation from established quality and safety standards, specifically concerning the microbiological integrity required for medical devices. The company is taking required actions by implementing a structured recall plan to remove all affected products, identified by specific models, specifications, and batch information detailed in the "Medical Device Recall Event Report Form" and "Recall Plan Implementation Status Table," from circulation. This proactive measure underscores the company's commitment to addressing regulatory deficiencies and ensuring public health safety by correcting the issue of potentially contaminated medical devices.

Company: https://www.globalkeysolutions.net/companies/kunming-kangye-medical-equipment-co-ltd/2d2fd440-ec74-4f96-a63c-ea874eb71dc3/