# China NMPA Product Recall - Disposable sterile vaginal speculum

Source: https://www.globalkeysolutions.net/records/china_product_recall/nanchang-medical-equipment-co-ltd/5f8a256b-7b59-4c9e-a0a3-97a7746d2615/
Source feed: China

> China NMPA product recall for Disposable sterile vaginal speculum by Nanchang Medical Equipment Co., Ltd. published December 10, 2018. Recall level: Level 3. Nanchang Fukang Medical Device Co., Ltd. initiated a voluntary Class III recall of its disposable st

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Nanchang Fukang Medical Device Co., Ltd. has voluntarily recalled its disposable sterile vaginal speculum.
- Company Name: Nanchang Medical Equipment Co., Ltd.
- Publication Date: 2018-12-10
- Product Name: Disposable sterile vaginal speculum
- Recall Level: Level 3
- Recall Reason: The structural strength and other items do not meet the standard requirements.
- Discovering Company: Nanchang Fukang Medical Equipment Co., Ltd.
- Manufacturing Company: Nanchang Medical Equipment Co., Ltd.
- Summary: Nanchang Fukang Medical Device Co., Ltd. initiated a voluntary Class III recall of its disposable sterile vaginal specula, a decision officially announced by the National Medical Products Administration (NMPA) on December 10, 2018. The recall stems from significant concerns regarding the product's quality, specifically its structural strength and other critical design aspects, which failed to meet established standard requirements. The affected product, registered under Medical Device Registration Certificate 20152660010, was identified as non-compliant following internal assessments or reports, prompting the company to take corrective action.
The NMPA, as the overseeing regulatory body in China, ensures the safety and efficacy of medical devices within its jurisdiction. This recall demonstrates the regulatory framework's commitment to public health by requiring companies to address product deficiencies promptly. Nanchang Fukang Medical Device Co., Ltd. is responsible for detailing the specific models, specifications, and batch numbers of the affected devices in a "Medical Device Recall Event Report Form" to facilitate the recall process. This voluntary action is a critical step to mitigate potential risks to users and uphold product safety standards, aligning with the NMPA's stringent oversight of medical device manufacturing and distribution.

Company: https://www.globalkeysolutions.net/companies/nanchang-medical-equipment-co-ltd/7015714e-5b20-4940-b684-b1e40cb5f2ff/