# China NMPA Product Recall - Disposable sterile vaginal speculum

Source: https://www.globalkeysolutions.net/records/china_product_recall/chongqing-xinwen-medical-equipment-co-ltd/20bd2692-0c07-4efa-b4d7-9c5c203e6435/
Source feed: China

> China NMPA product recall for Disposable sterile vaginal speculum by Chongqing Xinwen Medical Equipment Co., Ltd. published October 22, 2020. Recall level: Level 3 Recall. Chongqing Xinyi Medical Device Co., Ltd. initiated a voluntary Level III recall of its disposable st

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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: 2020-10-22
- 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 its disposable sterile vaginal specula (registration number "渝械注准20182180120") due to identified manufacturing defects. The National Medical Products Administration (NMPA) and the Chongqing Municipal Drug Administration publicly announced the recall on October 22, 2020, referencing a recall event report dated October 29, 2019. The affected products, specifically "Medium Type B" specula from batch number 1901012, produced on April 13, 2019, comprised 21,600 units distributed in Chongqing and Sichuan Provinces. The primary issues included a slight deviation in the blade aperture of the dilator component, with one or two holes being approximately one micrometer larger than standard. Furthermore, fasteners on some specula were found to loosen when subjected to a 30N force at maximum expansion. In response, Chongqing Xinyi Medical Device Co., Ltd. issued return notices to all affected medical institutions and businesses, prohibiting further sales. These entities were instructed to return the defective products by June 30th, after which the company would manage their proper disposal. This action demonstrates adherence to the regulatory framework ensuring medical device safety and quality.

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