# China NMPA Product Recall - Disposable surgical gowns

Source: https://www.globalkeysolutions.net/records/china_product_recall/nanchang-medical-equipment-co-ltd/93c9dddc-d363-4141-9d49-e83ae28b9fed/
Source feed: China

> China NMPA product recall for Disposable surgical gowns by Nanchang Medical Equipment Co., Ltd. published December 10, 2018. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) publicly reported on December 10, 2018, a volunt

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Nanchang Donghai Medical Equipment Co., Ltd. voluntarily recalls disposable surgical gowns.
- Company Name: Nanchang Medical Equipment Co., Ltd.
- Publication Date: 2018-12-10
- Product Name: Disposable surgical gowns
- Recall Level: Level 3 Recall
- Recall Reason: The tensile strength, sterility, and other items did not meet the standard requirements.
- Discovering Company: Nanchang Donghai Medical Equipment Co., Ltd.
- Manufacturing Company: Nanchang Medical Equipment Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) publicly reported on December 10, 2018, a voluntary Class III recall initiated by Nanchang Donghai Medical Equipment Co., Ltd. This recall pertains to their disposable surgical gowns, specifically registered under No. 20152640136. The company undertook this corrective action due to critical non-compliance with established product standards. The primary issues identified were deficiencies in both the tensile strength and the sterility of the surgical gowns. These violations represent significant concerns for patient safety and the integrity of medical procedures. Insufficient tensile strength could compromise the protective barrier during surgical use, potentially leading to material failure and exposure. Furthermore, a lack of sterility in a medical device like a surgical gown directly increases the risk of surgical site infections, posing serious health threats to patients. Operating within the regulatory oversight of the NMPA, Nanchang Donghai Medical Equipment Co., Ltd. proactively implemented this recall to address the identified product flaws. This action is a standard regulatory response designed to remove non-conforming medical devices from distribution, thereby safeguarding public health. Detailed information regarding the affected product models, specifications, and specific batch numbers was made available through the official 'Medical Device Recall Event Report Form' to facilitate effective removal from the market.

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