The Food and Drug Administration (FDA) has identified a Class I recall of Draeger SafeStar and TwinStar Filters due to a risk of misleading carbon dioxide readings. The readings 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.
Draeger SafeStar and TwinStar filters are bidirectional breathing system filters used during anesthesia and mechanical ventilation to protect against bacterial and viral contamination. They are typically used in hospitals during surgery or in intensive care units.
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.
In addition, the FDA Aug. 9 released a notice on a voluntary DermaRite recall of its DermaKleen, Dermasarra, Kleenfoam and Perigiene products due to a microbial contamination that can result in serious and life-threatening infections.
