# China NMPA Product Recall - Disposable sterile surgical gown

Source: https://www.globalkeysolutions.net/records/china_product_recall/xinxiang-dafang-medical-device-manufacturing-co-ltd/ef46945d-0be3-4911-8d59-f1ec64243706/
Source feed: China

> China NMPA product recall for Disposable sterile surgical gown by Xinxiang Dafang Medical Device Manufacturing Co., Ltd. published November 09, 2017. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) announced on November 9, 2017, a voluntary Level

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Xinxiang Dafang Medical Device Manufacturing Co., Ltd. has voluntarily recalled disposable sterile surgical gowns.
- Company Name: Xinxiang Dafang Medical Device Manufacturing Co., Ltd.
- Publication Date: 2017-11-09
- Product Name: Disposable sterile surgical gown
- Recall Level: Level 3 Recall
- Recall Reason: The sleeve burst strength and lateral tensile strength in non-critical areas do not meet the standard requirements.
- Discovering Company: Xinxiang Dafang Medical Device Manufacturing Co., Ltd.
- Manufacturing Company: Xinxiang Dafang Medical Device Manufacturing Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) announced on November 9, 2017, a voluntary Level III recall initiated by Xinxiang Dafang Medical Device Manufacturing Co., Ltd. This recall pertains to a specific batch of their disposable sterile surgical gowns. The primary reason for the recall was the discovery that these products failed to meet required standards for both sleeve burst strength and lateral tensile strength in non-critical areas. Xinxiang Dafang Medical Device Manufacturing Co., Ltd. proactively reported these findings, leading to their decision to recall the affected medical devices. While specific inspection dates are not detailed in the provided information, the company's action was a response to internal quality control findings. The NMPA serves as the regulatory authority overseeing such medical product safety events in China, ensuring compliance with established standards for medical devices. A Level III recall typically indicates a situation where exposure to a violative product is not likely to cause adverse health consequences. The required action for the company was the immediate recall of the identified batch of surgical gowns to prevent further distribution and use of non-conforming products.

Company: https://www.globalkeysolutions.net/companies/xinxiang-dafang-medical-device-manufacturing-co-ltd/f53fe2de-75e8-453d-8721-93d4cb0557a9/