FDA announces Class I ventilator recall for Draeger product’s pediatric use

Draeger Medical, Inc. is recalling its Carina Ventilators due to the presence of contaminants in the device’s airpath, which exceed acceptable levels if used by pediatric patients for more than 30 days. The Carina Sub-Acute Care Ventilator is used for people who require full or partial breathing assistance from a mechanical ventilator inside a hospital. The ventilator can be used for invasive (trachea tube) or non-invasive (mask) ventilation. The Food and Drug Administration has deemed this to be a Class I recall, due to the likelihood of serious injuries or death. Clinicians may continue to use the device with adult patients but are instructed to cease its use for pediatric patients.