China NMPA Product Recall - Medical ultrasound coupling agent

Guangzhou Yijie Medical Technology Co., Ltd. has initiated a voluntary Class III recall of its medical ultrasound coupling agent. The recall, publicly announced by the National Medical Products Administration (NMPA) on October 22, 2021, through the Guangdong Provincial Drug Administration, follows the company's discovery of an inaccuracy in the product's instructions for use. Specifically, the clinical use description was found to be incorrect, failing to comply with the established product classification and usage requirements stipulated in the standard "Medical Ultrasound Coupling Agent" (YY0299-2016). This critical discrepancy could potentially mislead clinicians regarding proper product application, thereby posing a risk of infection to patients. In response to these findings, Guangzhou Yijie Medical Technology Co., Ltd. undertook the recall action. Further details concerning the specific models, specifications, and batch numbers of the affected products are provided in a comprehensive "Medical Device Recall Event Report Form" accessible to relevant parties. This action reflects the company's commitment to addressing product safety concerns and adhering to regulatory compliance.