# China NMPA Product Recall - Disposable sterile vaginal speculum

Source: https://www.globalkeysolutions.net/records/china_product_recall/xinxiang-huaxi-medical-supplies-development-company/8970a828-6aa4-4124-a75c-f49ee215c535/
Source feed: China

> China NMPA product recall for Disposable sterile vaginal speculum by Xinxiang Huaxi Medical Supplies Development Company published January 11, 2019. Recall level: Level 3 Recall. Xinxiang Huaxi Medical Supplies Development Co., Ltd. initiated a voluntary recall of its disposable

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Xinxiang Huaxi Medical Supplies Development Company has voluntarily recalled disposable sterile vaginal specula devices.
- Company Name: Xinxiang Huaxi Medical Supplies Development Company
- Publication Date: 2019-01-11
- Product Name: Disposable sterile vaginal speculum
- Recall Level: Level 3 Recall
- Recall Reason: Ethylene oxide residue did not meet the standard requirements.
- Discovering Company: Xinxiang Huaxi Medical Supplies Development Company
- Manufacturing Company: Xinxiang Huaxi Medical Supplies Development Company
- Summary: Xinxiang Huaxi Medical Supplies Development Co., Ltd. initiated a voluntary recall of its disposable sterile vaginal specula products, as reported by the National Medical Products Administration (NMPA) on January 11, 2019. The company identified that the ethylene oxide residue content in certain batches of these devices did not meet established safety standards. This issue prompted a Level III recall, indicating a situation where exposure to the product is not likely to cause adverse health consequences but a recall is still warranted. The affected products include specific models, specifications, and batches, detailed in an accompanying Incident Report Form. This recall highlights the manufacturer's responsibility under the regulatory oversight of the NMPA to ensure product safety and compliance with quality specifications for medical devices distributed in the market. Xinxiang Huaxi Medical Supplies Development Co., Ltd. proactively took action to remove the non-compliant products from circulation to mitigate potential risks to public health, even if low. The NMPA serves as the central authority ensuring the safety and efficacy of medical products in China, and this recall demonstrates its role in overseeing industry compliance with regulatory requirements. The company's voluntary action underscores its commitment to product quality and patient safety, addressing the identified deviation from regulatory standards promptly.

Company: https://www.globalkeysolutions.net/companies/xinxiang-huaxi-medical-supplies-development-company/3680296d-2653-4a90-82f5-5117597cc330/