China NMPA Product Recall - Disposable surgical gowns

Nanchang Xingxing Medical Device Co., Ltd. initiated a voluntary Class III recall of its disposable surgical gowns, as reported to the National Medical Products Administration (NMPA) on December 10, 2019. The reason for this recall is that the sleeve material of the affected disposable surgical gowns did not meet established standard requirements. The specific product involved in this recall holds Registration Certificate No.: Ganxiezhuzhun 20172640179. The NMPA, as the regulatory body, oversees such medical device actions to ensure product quality and patient safety. While no specific inspection dates were provided, the company's voluntary action indicates a proactive measure to address the identified material deficiency. A Class III recall typically signifies that the use of or exposure to the non-compliant product is unlikely to cause severe adverse health consequences. To obtain comprehensive information regarding the specific models and batch numbers of the affected products, all relevant parties are directed to consult the "Medical Device Recall Event Report Form."