China NMPA Product Recall - Carbon Dioxide Absorbents

Armstrong Medical Ltd. has initiated a voluntary Level 1 recall for specific models and batches of its Carbon Dioxide Absorbents. This critical action, reported on December 15, 2021, addresses a significant product defect. The main issue identified is an unexpectedly high airflow resistance within these absorbents, which poses a serious risk by potentially impeding or entirely preventing effective ventilation during anesthesia procedures. This malfunction could lead to severe consequences for patient safety. The recall operates under the oversight of the National Medical Products Administration (NMPA), the regulatory body responsible for medical devices in China. A Level 1 classification, the most serious category, indicates a reasonable probability that using or being exposed to the defective product could cause serious adverse health consequences or death. In response, Armstrong Medical Ltd. is undertaking the required actions by recalling all affected products. Detailed information regarding the specific models, specifications, and batch numbers is available in the associated "Medical Device Recall Event Report Form." This measure is designed to proactively mitigate potential risks and ensure the safety of patients relying on these critical medical devices.