# China NMPA Product Recall - Disposable sterile surgical gown

Source: https://www.globalkeysolutions.net/records/china_product_recall/xinxiang-dafang-medical-device-manufacturing-co-ltd/94c26313-622d-4a2b-b847-ea80d8d92eaf/
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. Xinxiang Dafang Medical Device Manufacturing Co., Ltd. announced a voluntary Class III recall of its

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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: Xinxiang Dafang Medical Device Manufacturing Co., Ltd. announced a voluntary Class III recall of its disposable sterile surgical gowns, as reported by the National Medical Products Administration (NMPA) on November 9, 2017. The recall was initiated after the company discovered that specific batches of the surgical gowns failed to meet required standards for sleeve burst strength and lateral tensile strength in non-critical areas. This deficiency indicates a potential quality issue with the product's material integrity. The company, operating under the oversight of the NMPA, took the proactive step of recalling the affected products to ensure patient safety and compliance with medical device regulations. The required action involves the complete removal of the non-conforming disposable sterile surgical gowns from the market. Further details regarding the specific models and specifications of the recalled products are contained in the company's Medical Device Recall Event Report Form.

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