China NMPA Product Recall - Negative pressure wound therapy device (product name: RENASYS)

The National Medical Products Administration (NMPA) issued a notice concerning a voluntary recall initiated by Smith & Nephew, Inc. for its Negative Pressure Wound Therapy Device (RENASYS EZ PLUS). Reported on March 25, 2014, the recall addresses a potential leak in the device's start-up and operation circuit, which could result in vacuum leakage in the tubing. Smith & Nephew, Inc., the manufacturer, engaged in discussions with the U.S. FDA regarding this issue, leading to design improvements for the bacterial overflow filter and updates to the device's instruction manual. A key aspect of this recall is that the affected product was not imported or sold within China. Therefore, specific corrective actions for the Chinese market were deemed inapplicable. While the recall impacted products sold in 27 countries, including the United States, Smith & Nephew advised that devices currently on the market do not require physical removal; instead, users should continue correct usage following the updated instructions. The NMPA has requested its provincial and municipal food and drug administration departments to strengthen supervision over similar medical devices to ensure product safety.