China NMPA Product Recall - Disposable sterile vaginal speculum

Xinxiang Huaxi Medical Supplies Co., Ltd. initiated a voluntary Class III recall of a specific batch of its disposable sterile vaginal speculas, as reported on November 4, 2017. The company's action followed 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 recall was publicly announced on the aforementioned date. This action falls under the regulatory oversight of the National Medical Products Administration (NMPA), which published the recall notice. The company is responsible for implementing the recall, removing the non-compliant products from distribution, and ensuring that future products meet all quality and safety standards. The recall level of Class III indicates that the issue is unlikely to cause adverse health consequences but warrants product removal to prevent potential risks associated with substandard medical devices. The specific product models, specifications, and batch details are referenced in an attached Medical Device Recall Event Report Form.