Breathing System Filters Recall: Draeger Removes SafeStar and TwinStar Filters Due to Risk of Misleading Carbon Dioxide (CO₂) Readings

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US Food and Drug Administration

Breathing System Filters Recall: Draeger Removes SafeStar and TwinStar Filters Due to Risk of Misleading Carbon Dioxide (CO₂) Readings

**CVM is sharing these announcements because these products may be used in veterinary settings.**

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Reason for Recall

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

The use of affected filters may cause serious adverse health consequences, including airway injury, delayed or incorrect treatment, brain injury, and death.

There were serious injuries reported due to the slow increase of CO2 curve when using the sampling port of the filter. There have been no reports of death. 


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