FDA announces Class 1 recall for Draeger breathing filters

Editor's Note

The FDA has issued a Class 1 recall—the most severe category indicating risk of serious injury or death—for Draeger Filter SafeStar 90 Plus (MP05785), Filter SafeStar 55 Plus (MP05790), Filter SafeStar 60A Plus (MP05795), and Filter/HME TwinStar HEPA Plus (MP05801) breathing system filters, affecting all lot numbers.

Draeger is recalling these bidirectional breathing system filters, which are used during anesthesia and mechanical ventilation to protect against bacterial and viral contamination in hospitals during surgery or in intensive care units, due to the risk of misleading capnography (carbon dioxide) readings. This 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.

Healthcare facilities should immediately stop using affected filters and remove unused stock from inventory. Contact information for Draeger Customer Success and detailed instructions for product return and replacement are available in the full FDA announcement, which contains additional details about the recall process.