China NMPA Product Recall - 7DI Electric Gastric Lavage Machine

Jiangsu Yuyue Medical Equipment Co., Ltd. initiated a Level III voluntary recall for its 7DI Electric Gastric Lavage Machine on April 15, 2022. This action followed a National Medical Products Administration (NMPA) sampling inspection, which revealed a critical performance issue. The inspection determined that the device's flow rate, when used with an oral cannula, measured between 1.6-2.3 liters per minute, failing to meet the product's specified technical requirement of "not less than 2.0 liters per minute." The State Administration for Market Regulation also identified this key discrepancy.

The recall impacts numerous production batches, totaling approximately 2,506 units sold across China. In response, Jiangsu Yuyue Medical Equipment Co., Ltd. is mandated to promptly inform all distributors to halt sales of the affected products. Additionally, the company must conduct a comprehensive investigation into the root causes of this non-compliance and develop robust corrective measures to rectify the identified performance deficiency. This recall highlights the regulatory oversight by the NMPA to ensure medical devices adhere to established performance standards.