NEW YORK, Aug 16: The US Food and Drug Administration (FDA) has announced a Class I recall of Draeger SafeStar and TwinStar Filters due to the risk of misleading carbon dioxide readings, which could lead to serious injuries. A Class I recall is the most severe type, indicating a reasonable probability that the product could cause serious adverse health consequences or death.

The affected filters are bidirectional breathing system filters used during anesthesia and mechanical ventilation. They are designed to remove contaminants, but the FDA warned that using these filters could result in airway injury, delayed or incorrect treatment, brain injury, and other severe complications.

The FDA noted that serious injuries have already been reported due to the slow rise in the carbon dioxide curve when using the sampling port of the filter. However, no deaths have been reported so far.

“Draeger is recalling these filters due to the risk of misleading capnography (carbon dioxide) readings, which could result in healthcare providers administering unnecessary or harmful treatments based on incorrect waveform interpretations,” the FDA said.

Healthcare providers and anyone using these devices are urged to stop using them immediately. The FDA advises contacting a Draeger Consumables Representative for information about alternative filters.

Recalls like this highlight the importance of following FDA guidance to ensure public safety.