China NMPA Product Recall - Medium frequency drug delivery device

On May 20, 2019, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Shenyang Meichen Medical Device Co., Ltd. This recall, also noted by the Liaoning Provincial Drug Administration on May 16, 2019, concerns their ultrasonic intermediate-frequency drug delivery device (Registration Certificate No.: Liaoning Medical Device Registration 20182230030). The core issue identified is a potential defect involving excessive internal adhesive within the treatment head accessory. This manufacturing irregularity may lead to an attenuation of the device's ultrasonic output power, thereby reducing its intended therapeutic efficacy. In response to this product concern, Shenyang Meichen Medical Device Co., Ltd. has voluntarily recalled the affected devices to address the potential reduction in treatment effect. The company has detailed specific affected product types and batch information in a