# China NMPA Product Recall - Medical vaginal douche

Source: https://www.globalkeysolutions.net/records/china_product_recall/kunming-chuangbang-medical-equipment-co-ltd/7321c62c-6d89-4df7-b108-192c51c8e481/
Source feed: China

> China NMPA product recall for Medical vaginal douche by Kunming Chuangbang Medical Equipment Co., Ltd. published December 19, 2018. Recall level: Level 3 Recall. Kunming Chuangbang Medical Device Co., Ltd. has initiated a voluntary Class III recall for a specifi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Kunming Chuangbang Medical Devices Co., Ltd. voluntarily recalls medical vaginal douches.
- Company Name: Kunming Chuangbang Medical Equipment Co., Ltd.
- Publication Date: 2018-12-19
- Product Name: Medical vaginal douche
- Recall Level: Level 3 Recall
- Recall Reason: The National Aircraft Administration's flight inspection revealed serious deficiencies in the production quality management system.
- Discovering Company: Kunming Chuangbang Medical Equipment Co., Ltd.
- Manufacturing Company: Kunming Chuangbang Medical Equipment Co., Ltd.
- Summary: Kunming Chuangbang Medical Device Co., Ltd. has initiated a voluntary Class III recall for a specific batch of its medical vaginal irrigators. This decisive action, formally reported on December 19, 2018, targets products from batch 20180201, which are registered under the number Dian Kun Xie Bei 20140023. The recall stems from serious defects discovered within the company's production quality management system. These critical deficiencies in manufacturing and quality control processes were identified during a comprehensive national inspection. As a direct consequence of these findings, Kunming Chuangbang Medical Device Co., Ltd. is voluntarily removing the affected medical vaginal irrigators from distribution channels and the market to mitigate potential risks. The Class III recall designation indicates that the product may cause adverse health consequences, but these are unlikely to be life-threatening or permanent. This regulatory action is in adherence to the guidelines and oversight of the National Medical Products Administration (NMPA), the regulatory authority responsible for ensuring the safety and efficacy of medical devices in China. The company's proactive measure underscores its commitment to addressing the identified systemic production issues and ensuring compliance with national medical device regulations to protect patient safety. Additional specifics regarding product models and related information are documented in the "Medical Device Recall Event Report Form" issued by the company.

Company: https://www.globalkeysolutions.net/companies/kunming-chuangbang-medical-equipment-co-ltd/9ce59e53-8733-4003-ace9-e2018798c8db/