# China NMPA Product Recall - Disposable sterile vaginal speculum

Source: https://www.globalkeysolutions.net/records/china_product_recall/jiangxi-huaqiang-medical-device-co-ltd-nanchang-huayi-medical-device-co-ltd-jiangxi-jiangling-group-health-technology-co-ltd-nanchang-kangjie-medical-and-hygiene-products-co-ltd-nanchang-weiwei-latex-manufacturing-co-ltd/b095f622-1819-4c89-afa8-118654529457/
Source feed: China

> China NMPA product recall for Disposable sterile vaginal speculum by Jiangxi Huaqiang Medical Device Co., Ltd., Nanchang Huayi Medical Device Co., Ltd., Jiangxi Jiangling Group Health Technology Co., Ltd., Nanchang Kangjie Medical and Hygiene Products Co., Ltd., Nanchang Weiwei Latex Manufacturing Co., Ltd. published December 10, 2018. Recall level: Level 3 Recall. Nanchang Kangjie Medical Hygiene Products Co., Ltd. initiated a voluntary Class III recall of its di

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Nanchang Kangjie Medical and Hygiene Products Co., Ltd. has voluntarily recalled disposable sterile vaginal specula devices.
- Company Name: Jiangxi Huaqiang Medical Device Co., Ltd., Nanchang Huayi Medical Device Co., Ltd., Jiangxi Jiangling Group Health Technology Co., Ltd., Nanchang Kangjie Medical and Hygiene Products Co., Ltd., Nanchang Weiwei Latex Manufacturing Co., Ltd.
- Publication Date: 2018-12-10
- Product Name: Disposable sterile vaginal speculum
- Recall Level: Level 3 Recall
- Recall Reason: Items such as ethylene oxide residue did not meet the standard requirements.
- Discovering Company: Nanchang Kangjie Medical and Hygiene Products Co., Ltd.
- Manufacturing Company: Jiangxi Huaqiang Medical Device Co., Ltd., Nanchang Huayi Medical Device Co., Ltd., Jiangxi Jiangling Group Health Technology Co., Ltd., Nanchang Kangjie Medical and Hygiene Products Co., Ltd., Nanchang Weiwei Latex Manufacturing Co., Ltd.
- Summary: Nanchang Kangjie Medical Hygiene Products Co., Ltd. initiated a voluntary Class III recall of its disposable sterile vaginal specula (Registration No.: Ganxiezhuzhun 20152660130), as reported by the National Medical Products Administration (NMPA) on December 10, 2018. The primary reason for this action was the detection of ethylene oxide residue levels that did not conform to standard requirements, indicating a potential compromise in product safety and quality. The specific dates of any inspections leading to this discovery were not detailed in the public recall announcement. The regulatory framework under which this recall occurred is the NMPA, which oversees medical device safety and compliance in China. As a required action, Nanchang Kangjie Medical Hygiene Products Co., Ltd. is actively withdrawing the affected products from distribution. A Class III recall typically implies that exposure to the product is unlikely to cause severe adverse health consequences. Comprehensive details regarding the specific models, specifications, and batch numbers of the recalled devices are documented in an accompanying "Medical Device Recall Event Report Form" not provided here. This recall highlights the company's commitment to upholding regulatory standards and ensuring patient safety.

Company: https://www.globalkeysolutions.net/companies/jiangxi-huaqiang-medical-device-co-ltd-nanchang-huayi-medical-device-co-ltd-jiangxi-jiangling-group-health-technology-co-ltd-nanchang-kangjie-medical-and-hygiene-products-co-ltd-nanchang-weiwei-latex-manufacturing-co-ltd/b5142890-5d2f-42ce-a3c4-2efec0604684/