US Food and Drug Administration (FDA) Recall of Carina Ventilators

August 28, 2023 | by sau1admin

The Office of Developmental Programs is sharing the following recall information announced by the U.S. Food and Drug Administration (FDA).

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 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.

If you have questions about this recall, contact Draeger Service Technical Support between the hours of 8:00 AM – 8:00 PM EST at 1-800-437-2437 (press 2 at the prompt, then 2 again).

Further information is available at Draeger Recalls Carina Sub-Acute Care Ventilators for Contaminants in Airpath | FDA