China NMPA Product Recall - Breathing circuit

Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its manufactured breathing circuits (Registration Certificate No.: 20162661685), as announced by the National Medical Products Administration (NMPA) on January 21, 2021. This action stemmed from global post-marketing product monitoring, which revealed a critical issue where the Y-shaped component of the breathing circuit could detach from the breathing tubing before or during ventilation. Investigations conducted by Dräger identified that the affected Y-shaped component and its associated adhesive joint did not meet specified quality standards. Further analysis confirmed that manufacturing deficiencies could cause the component to detach when subjected to lower-than-standard tensile strength. This defect potentially impacts breathing circuits shipped from January 1, 2018, indicating a limited lifespan for the adhesive joints in these units. Although no adverse health effects on patients have been reported in connection with this issue, the company proceeded with the recall to address the potential safety risk. Dräger Medical Devices (Shanghai) Co., Ltd. is taking required actions to remove the affected products from the market, with detailed information on specific models, specifications, and batches provided in the "Medical Device Recall Event Report Form." This recall falls under the regulatory oversight of the NMPA to ensure public health and product safety.