# China NMPA Product Recall - Medical disposable protective clothing

Source: https://www.globalkeysolutions.net/records/china_product_recall/zhongke-shuangying-medical-technology-co-ltd/da2d72b2-ceb4-42df-9875-40a01dbf553e/
Source feed: China

> China NMPA product recall for Medical disposable protective clothing by Zhongke Shuangying Medical Technology Co., Ltd. published July 08, 2022. Recall level: Level III. Zhongke Shuangying Medical Technology Co., Ltd. initiated a voluntary Class III recall for its dispo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Zhongke Shuangying Medical Technology Co., Ltd. voluntarily recalls disposable medical protective clothing.
- Company Name: Zhongke Shuangying Medical Technology Co., Ltd.
- Publication Date: 2022-07-08
- Product Name: Medical disposable protective clothing
- Recall Level: Level III
- Recall Reason: The appearance and sterility did not meet the technical requirements of product "桂械注准20202140250".
- Discovering Company: Zhongke Shuangying Medical Technology Co., Ltd.
- Manufacturing Company: Zhongke Shuangying Medical Technology Co., Ltd.
- Summary: Zhongke Shuangying Medical Technology Co., Ltd. initiated a voluntary Class III recall for its disposable medical protective clothing (Batch No.: 20210321), as announced on July 8, 2022. This action stemmed from a random inspection conducted by the Jilin Provincial Drug Administration in Songyuan City, Jilin Province. Subsequent testing by the Jilin Provincial Medical Device Testing Institute determined that the product’s appearance and sterility did not meet the specified technical requirements outlined in its registration certificate (Gui Xie Zhu Zhun 20202140250). The regulatory framework for this recall involves provincial drug administrations operating under the National Medical Products Administration (NMPA). The company’s required action is a voluntary recall of the affected batch, with further details on model and specifications provided in the "Medical Device Recall Event Report Form" dated July 6, 2022. This ensures the removal of substandard protective clothing from use.

Company: https://www.globalkeysolutions.net/companies/zhongke-shuangying-medical-technology-co-ltd/5e167077-aba7-4f32-bcb0-1643cd962770/