# China NMPA Product Recall - Disposable sterile vaginal speculum

Source: https://www.globalkeysolutions.net/records/china_product_recall/nanchang-medical-equipment-co-ltd/75a4e385-f59f-47c6-a924-cebb2e384c2c/
Source feed: China

> China NMPA product recall for Disposable sterile vaginal speculum by Nanchang Medical Equipment Co., Ltd. published May 21, 2019. Recall level: Level 3 Recall. Nanchang Aibo Medical Device Co., Ltd. has initiated a voluntary Class III recall for its disposable

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Nanchang Aibo Medical Device Co., Ltd. voluntarily recalls disposable sterile vaginal speculum.
- Company Name: Nanchang Medical Equipment Co., Ltd.
- Publication Date: 2019-05-21
- Product Name: Disposable sterile vaginal speculum
- Recall Level: Level 3 Recall
- Recall Reason: Electronic components vary in thickness
- Discovering Company: Nanchang Aibo Medical Equipment Co., Ltd.
- Manufacturing Company: Nanchang Medical Equipment Co., Ltd.
- Summary: Nanchang Aibo Medical Device Co., Ltd. has initiated a voluntary Class III recall for its disposable sterile vaginal specula, identified by the Index Number Ganxiezhuzhun 20152660171. This significant regulatory action, published by the National Medical Products Administration (NMPA) on May 21, 2019, stems from a critical manufacturing concern. The primary issue identified involves inconsistent thickness in the electronic components integrated into these medical devices. Such variations in component specifications are serious as they can compromise the device's intended functionality, potentially affecting its performance and patient safety during use. The company proactively reported this quality deviation, leading to the voluntary recall as a necessary corrective action to mitigate risks associated with the defective products. A Class III recall typically addresses situations where the use of a violative product is not likely to cause adverse health consequences. Specific details concerning the affected product models, precise specifications, and relevant batch numbers are further elaborated in the accompanying 'Medical Device Recall Event Report Form'. This incident highlights the robust regulatory framework enforced by the NMPA, which mandates that manufacturers maintain stringent quality control and respond decisively to product non-conformities, thereby safeguarding public health and ensuring the reliability of medical devices distributed within the market.

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