# China NMPA Product Recall - Disposable sterile vaginal speculum

Source: https://www.globalkeysolutions.net/records/china_product_recall/xinxiang-huaxi-medical-supplies-co-ltd/7eb657fe-3f1b-4419-8a21-1a70f1276a04/
Source feed: China

> China NMPA product recall for Disposable sterile vaginal speculum by Xinxiang Huaxi Medical Supplies Co., Ltd. published November 04, 2017. Recall level: Level 3 Recall. Xinxiang Huaxi Medical Supplies Co., Ltd. initiated a voluntary Class III recall of a specific batch

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Xinxiang Huaxi Medical Supplies Co., Ltd. has voluntarily recalled its disposable sterile vaginal speculum.
- Company Name: Xinxiang Huaxi Medical Supplies Co., Ltd.
- Publication Date: 2017-11-04
- Product Name: Disposable sterile vaginal speculum
- Recall Level: Level 3 Recall
- Recall Reason: The amount of residue does not meet the standard requirements.
- Discovering Company: Xinxiang Huaxi Medical Supplies Co., Ltd.
- Manufacturing Company: Xinxiang Huaxi Medical Supplies Co., Ltd.
- Summary: Xinxiang Huaxi Medical Supplies Co., Ltd. initiated a voluntary Class III recall of a specific batch of its disposable sterile vaginal speculas, as reported on November 4, 2017. The company's action followed the discovery that the residual quantity of these medical devices did not comply with established standard requirements. While the document does not specify inspection dates, the recall was publicly announced on the aforementioned date. This action falls under the regulatory oversight of the National Medical Products Administration (NMPA), which published the recall notice. The company is responsible for implementing the recall, removing the non-compliant products from distribution, and ensuring that future products meet all quality and safety standards. The recall level of Class III indicates that the issue is unlikely to cause adverse health consequences but warrants product removal to prevent potential risks associated with substandard medical devices. The specific product models, specifications, and batch details are referenced in an attached Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/xinxiang-huaxi-medical-supplies-co-ltd/58c01494-7dcb-4cd8-aa4b-7df2597c9f13/