# China NMPA Product Recall - Disposable sterile vaginal speculum

Source: https://www.globalkeysolutions.net/records/china_product_recall/chongqing-xinwen-medical-equipment-co-ltd/48311c39-656b-4510-9794-5a493a8af333
Source feed: China

> China NMPA product recall for Disposable sterile vaginal speculum by Chongqing Xinwen Medical Equipment Co., Ltd. published April 12, 2021. Recall level: Level 3 Recall. Chongqing Xinyi Medical Device Co., Ltd. initiated a voluntary Level III recall of 21,600 units of i

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Chongqing Xinyi Medical Device Co., Ltd. has voluntarily recalled its disposable sterile vaginal speculum.
- Company Name: Chongqing Xinwen Medical Equipment Co., Ltd.
- Publication Date: 2021-04-12
- Product Name: Disposable sterile vaginal speculum
- Recall Level: Level 3 Recall
- Recall Reason: During the adjustment process, one or two holes on the expander component had slight deviations in diameter, about one micrometer larger than normal. When the expander was expanded to its maximum setting and a force of 30N was applied, the buckle on some products would come off.
- Discovering Company: Chongqing Xinyi Medical Equipment Co., Ltd.
- Manufacturing Company: Chongqing Xinwen Medical Equipment Co., Ltd.
- Summary: Chongqing Xinyi Medical Device Co., Ltd. initiated a voluntary Level III recall of 21,600 units of its Disposable Sterile Vaginal Specula (Model B, Medium, Batch 1901012), produced on April 13, 2019. This recall, reported to the National Medical Products Administration (NMPA) on October 29, 2019, primarily affects Chongqing and Sichuan Provinces, China. The main issue stemmed from production adjustments, where some expander components exhibited slight diameter deviations of approximately one micrometer in specific holes. More critically, when the specula were expanded to their maximum setting and subjected to a 30N force, fasteners detached on certain products. This defect could compromise the device's stability and safe operation during gynecological examinations in medical institutions. Under NMPA oversight, the company implemented corrective actions requiring medical institutions and distributors to cease sales immediately. Return notices were issued, and all affected products were to be returned to Chongqing Xinyi Medical Device Co., Ltd. by June 30th for proper disposal. This action ensures patient safety by removing non-conforming devices from circulation.

Company: https://www.globalkeysolutions.net/companies/chongqing-xinwen-medical-equipment-co-ltd/22d3041b-7d39-4763-9510-a878faa151a8