Draeger has recalled its SafeStar and TwinStar breathing system filters due to a risk of misleading carbon dioxide readings.
The recall includes lot numbers SafeStar 90 plus, SafeStar 55 plus, SafeStar 60A plus and TwinStar HEPA Plus, according to an Aug. 12 news release from the FDA. The issue with the products could result in life-threatening complications, including airway injury, delayed or incorrect treatment, brain injury or death.
The filters, primarily used in operating rooms and intensive care units, are used during anesthesia and mechanical ventilation to prevent bacterial and viral contamination.
Editor’s note: A previous version of this article incorrectly stated the recall was due to a carbon monoxide risk. The correct substance is carbon dioxide. The article was updated Aug. 15 to reflect this correction.
