# China NMPA Product Recall - Disposable medical sterile cotton swabs

Source: https://www.globalkeysolutions.net/records/china_product_recall/yunnan-chenye-medical-equipment-co-ltd/5b70b21e-9632-4418-a6b7-13bd8bb5bb73/
Source feed: China

> China NMPA product recall for Disposable medical sterile cotton swabs by Yunnan Chenye Medical Equipment Co., Ltd. published October 26, 2021. Recall level: Level 3 Recall. On October 26, 2021, the National Medical Products Administration (NMPA) published a notice detailin

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Yunnan Chenye Medical Device Co., Ltd. has voluntarily recalled disposable medical sterile cotton swabs.
- Company Name: Yunnan Chenye Medical Equipment Co., Ltd.
- Publication Date: 2021-10-26
- Product Name: Disposable medical sterile cotton swabs
- Recall Level: Level 3 Recall
- Recall Reason: The aseptic requirement was not met.
- Discovering Company: Yunnan Chenye Medical Equipment Co., Ltd.
- Manufacturing Company: Yunnan Chenye Medical Equipment Co., Ltd.
- Summary: On October 26, 2021, the National Medical Products Administration (NMPA) published a notice detailing a voluntary recall initiated by Yunnan Chenye Medical Device Co., Ltd. The company is recalling its disposable sterile medical swabs (Registration Certificate No.: Dianxiezhuzhun 20162640075) due to non-compliance with sterility requirements. This issue represents a critical quality control failure, as maintaining sterility is paramount for medical devices of this nature to ensure patient safety and prevent potential infections.
The recall has been categorized as a Level III recall, indicating that while a violative product is involved, its use or exposure is not expected to cause serious adverse health consequences. This classification, established under the NMPA's regulatory framework, helps define the urgency and scope of the recall process. Yunnan Chenye Medical Device Co., Ltd. voluntarily initiated this action, reporting the identified non-compliance and proceeding with the recall of specific affected product models, specifications, and batches.
The company is required to adhere to a structured recall plan, as evidenced by the mention of a "Medical Device Recall Event Report Form" and "Recall Plan Implementation Report Form." These documents outline the precise details of the affected products and the steps undertaken to remove them from distribution and use. The NMPA, as the overseeing regulatory body, monitors such actions to safeguard public health and ensure compliance with medical device standards.

Company: https://www.globalkeysolutions.net/companies/yunnan-chenye-medical-equipment-co-ltd/ead51249-6893-447c-98ad-3a9bdacb20fd/