China NMPA Product Recall - Heated Breathing Circuit

Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its VentStar Helix heated disposable breathing circuit, as announced by the National Medical Products Administration (NMPA) on May 11, 2020. This action follows the discovery of an overseas incident where the breathing circuit was improperly used in conjunction with a Fisher & Paykel MR810 humidifier. The company's registration certificate and instructions for use explicitly state that the VentStar Helix circuit is only approved for use with the Fisher & Paykel MR850 humidifier. The primary safety concern arises from the unapproved combination with the MR810 humidifier, which can lead to undetected damage to the heating wire. This damage poses a significant risk of igniting the breathing gas, potentially causing severe burns to patients. Dräger emphasized that it only supplies the approved VentStar Helix circuits and MR850 humidifiers to its customers. Although no similar incidents or adverse events have been reported within China, the company is proactively recalling affected products to prevent potential patient harm. Detailed information regarding specific models and batches is available in the "Medical Device Recall Event Report Form." This recall underscores the critical importance of adhering to specified product compatibility to ensure patient safety within the medical device regulatory framework.