China NMPA Product Recall - Disposable sterile vaginal speculum

Changzhou Chuangjia Medical Device Co., Ltd. has initiated a voluntary Class III recall for its disposable sterile vaginal specula. This action stems from a 2018 national medical device spot check, conducted under the National Medical Products Administration (NMPA) of China, which identified non-compliance with "structural strength" standards. The affected products belong to production batch number 20180304, with 6100 units produced. The issue was initially detected through product sampling at Xiangya Hospital of Central South University, where 2400 units from the substandard batch were still in inventory. As part of the required actions, Changzhou Chuangjia Medical Device Co., Ltd. is contacting user facilities, like Xiangya Hospital, to confirm existing inventory and facilitate the return of the recalled products. All returned items are to be processed according to the company's internal regulations, ensuring that products failing to meet essential structural integrity standards are removed from circulation to protect patient safety and uphold product quality.