China NMPA Product Recall - Disposable sterile vaginal speculum

The National Medical Products Administration (NMPA) issued a recall notification on November 4, 2017, concerning a voluntary recall initiated by Xinxiang Huaxi Medical Supplies Co., Ltd. The recall targets a specific production batch of disposable sterile vaginal speculas manufactured by the company. The core issue leading to this action was the discovery that the residual quantity of these medical devices did not comply with established standard requirements. While the document does not specify inspection dates, the company proactively identified the non-conformance, prompting the recall. Operating under the NMPA's regulatory framework for medical products, Xinxiang Huaxi Medical Supplies Co., Ltd. has classified this as a Class III recall. A Class III recall typically indicates a situation where the use of, or exposure to, the non-compliant product is unlikely to cause adverse health consequences. The company's required action involves the voluntary recall of the entire affected batch of disposable sterile vaginal speculas. Further details, including specific product models, specifications, and batch numbers, are referenced as being contained within an attached "Medical Device Recall Event Report Form." This measure ensures the removal of non-compliant products from the supply chain, thereby upholding patient safety and product quality standards.