# China NMPA Product Recall - Disposable sterile vaginal speculum

Source: https://www.globalkeysolutions.net/records/china_product_recall/henan-yadu-industrial-co-ltd/45288dff-055d-411f-9db9-aad6faddef1b/
Source feed: China

> China NMPA product recall for Disposable sterile vaginal speculum by Henan Yadu Industrial Co., Ltd. published November 02, 2017. Recall level: Level 3 Recall. On November 2, 2017, the National Medical Products Administration (NMPA) announced that Henan Yadu I

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Henan Yadu Industrial Co., Ltd. has voluntarily recalled its disposable sterile vaginal speculum.
- Company Name: Henan Yadu Industrial Co., Ltd.
- Publication Date: 2017-11-02
- Product Name: Disposable sterile vaginal speculum
- Recall Level: Level 3 Recall
- Recall Reason: Resistance to non-compliance with standard requirements
- Discovering Company: Henan Yadu Industrial Co., Ltd.
- Manufacturing Company: Henan Yadu Industrial Co., Ltd.
- Summary: On November 2, 2017, the National Medical Products Administration (NMPA) announced that Henan Yadu Industrial Co., Ltd. initiated a voluntary Class III recall concerning a specific batch of its disposable sterile vaginal specula. This significant action was undertaken after the company identified a critical quality defect: the antimicrobial activity of these medical devices did not meet established standard requirements. The proactive identification of this non-compliance by Henan Yadu Industrial Co., Ltd. led to their decision to voluntarily remove the affected products from the market to ensure patient safety and product efficacy. The Class III recall designation, as per regulatory guidelines, indicates that while the product defect is a quality concern, it is unlikely to cause serious adverse health consequences. This recall highlights the stringent regulatory environment governed by the NMPA, which mandates that medical device manufacturers continuously monitor and ensure their products meet all necessary performance and safety standards throughout their lifecycle. Henan Yadu Industrial Co., Ltd.'s required action involved a comprehensive recall of the identified batch, emphasizing the company's responsibility to uphold product quality and regulatory compliance within the medical device industry. This event underscores the continuous oversight necessary to maintain the integrity and reliability of medical products in the market.

Company: https://www.globalkeysolutions.net/companies/henan-yadu-industrial-co-ltd/0f82c580-0461-489f-b66c-d50d3d25a206/