# China NMPA Product Recall - Medical gauze dressing

Source: https://www.keypedia.com/records/china_product_recall/nanchang-medical-equipment-co-ltd/7bfe177f-b472-4ffb-9a83-42ce38db3470
Source feed: China

> China NMPA product recall for Medical gauze dressing by Nanchang Medical Equipment Co., Ltd. published January 10, 2020. Recall level: Level 3. Nanchang Tongda Medical Device Co., Ltd. initiated a voluntary Class III recall for its medical gauz

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Nanchang Tongda Medical Device Co., Ltd. reported a voluntary recall of its medical gauze dressings (Registration Certificate No.: Gan Shi Yao Jian Xie (Zhun) Zi 2014 No. 2640116) due to non-compliance with standards. The recall level is Class III. Detailed information regarding the affected product models, specifications, and batches can be found in the "Medical Device Recall Event Report Form".
- Company Name: Nanchang Medical Equipment Co., Ltd.
- Publication Date: 2020-01-10
- Product Name: Medical gauze dressing
- Recall Level: Level 3
- Recall Reason: Medical gauze dressings failed to meet the required standards after testing.
- Discovering Company: Nanchang Tongda Medical Equipment Co., Ltd.
- Manufacturing Company: Nanchang Medical Equipment Co., Ltd.
- Summary: Nanchang Tongda Medical Device Co., Ltd. initiated a voluntary Class III recall for its medical gauze dressings, publicly announced on January 10, 2020. This decisive action was necessitated by the product's failure to adhere to established quality and safety standards. The specific product involved, identified by Registration Certificate No. Gan Shi Yao Jian Xie (Zhun) Zi 2014 No. 2640116, was proactively withdrawn from distribution by the company. The regulatory oversight for this event is provided by the National Medical Products Administration (NMPA), the primary authority governing medical devices in China. As a required action, Nanchang Tongda Medical Device Co., Ltd. submitted a 'Medical Device Recall Event Report Form,' which contains comprehensive details regarding the specific models and batch numbers of the affected products. This voluntary recall highlights the company's commitment to product integrity and public health, addressing identified deficiencies without a preceding regulatory inspection. The recall process ensures that non-compliant products are removed from the market, safeguarding patients and maintaining confidence in medical supplies.

Company: https://www.keypedia.com/companies/nanchang-medical-equipment-co-ltd/7015714e-5b20-4940-b684-b1e40cb5f2ff