China NMPA Product Recall - 7DI Electric Gastric Lavage Machine

Jiangsu Yuyue Medical Equipment Co., Ltd. has initiated a voluntary Level III recall of its 7DI Electric Gastric Lavage Machine following a sampling inspection by the National Medical Products Administration (NMPA) and the State Administration for Market Regulation. The recall, reported on April 15, 2022, addresses a critical product performance issue. The primary violation identified was that the machine's flow rate, when using an oral cannula, measured between 1.6-2.3 liters per minute, falling short of the product's technical specification requiring a flow rate of not less than 2.0 liters per minute. This discrepancy impacts the device's intended clinical application for gastric lavage on patients. Under the guidance of the NMPA, the company is undertaking several required actions. These include promptly notifying all distributors in China to halt sales and implement corrective measures for all affected products across numerous production batches, ranging from 2017 to 2021. Furthermore, Jiangsu Yuyue Medical Equipment Co., Ltd. is mandated to thoroughly analyze the root causes of this non-compliance and develop comprehensive corrective actions to prevent recurrence. This recall ensures that medical institutions receive devices that meet established performance and safety standards.