The Food and Drug Administration (FDA), on August 23, identified the recall by Draeger Medical of its Carina Sub-Acute Care Ventilators as Class I, the most serious.
The recall was initiated because of the presence of contaminants in the device’s airpath. The contaminants exceed acceptable levels if the ventilators are used on pediatric patients for more than 30 days.
The company will be updating affected devices to address this issue; the ventilators may continue to be used on adult patients.
No complaints, incidents, or deaths have been associated with this issue.
Distribution dates were March 16, 2009, to October 30, 2023.Read More >>