# China NMPA Product Recall - Disposable medical sterile cotton swabs

Source: https://www.globalkeysolutions.net/records/china_product_recall/yunnan-chenye-medical-equipment-co-ltd/dc74aaef-2333-4ca6-8c82-cd8ae2de63ac/
Source feed: China

> China NMPA product recall for Disposable medical sterile cotton swabs by Yunnan Chenye Medical Equipment Co., Ltd. published December 04, 2017. Recall level: . Yunnan Chenye Medical Device Co., Ltd. initiated a voluntary recall of its disposable sterile medica

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Yunnan Chenye Medical Device Co., Ltd. voluntarily recalls disposable medical sterile cotton swabs
- Company Name: Yunnan Chenye Medical Equipment Co., Ltd.
- Publication Date: 2017-12-04
- Product Name: Disposable medical sterile cotton swabs
- Recall Reason: The sample failed the inspection in Yunnan Province (it contained substandard bacteria).
- Discovering Company: Yunnan Chenye Medical Equipment Co., Ltd.
- Manufacturing Company: Yunnan Chenye Medical Equipment Co., Ltd.
- Summary: Yunnan Chenye Medical Device Co., Ltd. initiated a voluntary recall of its disposable sterile medical swabs (Registration No.: Dianxiezhuzhun 20162640075) following the discovery of unqualified bacteria test results. This critical quality issue was identified during a supervision and inspection conducted by the Yunnan Provincial Drug Administration. The recall was reported on November 30, 2017, and publicly announced by the National Medical Products Administration (NMPA) on December 4, 2017, under Index No. JGXX-2017-11172.

The main violation involved the presence of unacceptable bacterial levels in the sterile medical swabs, indicating a failure to meet essential sterility standards. This non-conformance posed a potential risk to patient safety and product efficacy. Under the guidance of the NMPA's regulatory framework, Yunnan Chenye Medical Device Co., Ltd. was required to undertake a voluntary recall of the affected products. Detailed information regarding the specific models, specifications, and batch numbers of the implicated swabs is provided in the "Medical Device Recall Event Report Form," emphasizing the company's commitment to address the quality lapse and ensure public health.

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