China NMPA Product Recall - Negative pressure wound therapy device (RENASYS GO) (power adapter)

Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., representing manufacturer Smith & Nephew, Inc., initiated a voluntary Level II recall of specific Negative Pressure Wound Therapy Devices (RENASYS). This action, internally reported on February 25, 2016, and publicly announced by the National Medical Products Administration (NMPA) on April 21, 2016, stemmed from numerous customer complaints. The core issue identified was that the power adapter (model 66800161) overheats when utilized with the RENASYS negative pressure wound therapy device main unit (specifically model 66800164). The recall targets adapters with serial numbers below 144500875. This recall adheres to the NMPA's medical device regulatory framework, documented through a "Medical Device Recall Event Report Form" and associated with CFDA approval number 20122542966.

To mitigate the safety risk, Smith & Nephew has outlined clear corrective actions. Users are required to immediately disconnect any affected power adapter. The company will manage the recall process and provide replacements for the identified faulty adapters. It is important to note that the RENASYS device itself, including its built-in battery functionality, remains safe and operational for continued treatment once the external adapter is disconnected. Additionally, the use of any non-Smith & Nephew external power adapters with the device is strictly prohibited. This global recall aims to proactively address potential overheating hazards and ensure patient safety across various countries.