Draeger Medical, Inc. is recalling its Carina Ventilators due to the presence of contaminants in the device’s airpath. The contaminants exceed acceptable levels if used by pediatric patients for more than 30 days. During testing, the firm found polyether polyurethane (PE-PUR) in the airpath of the Carina ventilator. This results in the emission of contaminant 1,3-Dichloropropan-2-ol, a potential carcinogen.

Please be aware, this recall is a voluntary correction, not a product removal.

Clinicians may continue to use the devices with adult patients and are instructed to not use the devices with pediatric patients.

The Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Read more about the recall on the FDA’s website.