FDA classifies Draeger’s recall of ventilators as Class I

This week, the FDA labeled Draeger’s recall of some ventilators as Class I, the most serious kind.

Draeger issued a voluntary correction, not a product removal, of specific Carina sub-acute care ventilators. The company said clinicians may continue to use the devices with adult patients and are instructed not to use the devices with pediatric patients.

Draeger is recalling the Carina ventilators due to contaminants in the device’s airpath. The contaminants exceed acceptable levels if used by pediatric patients for more than 30 days. Draeger found polyether polyurethane during testing in the airpath of the Carina ventilator. This results in the emission of contaminant 1,3-Dichloropropan-2-ol, a potential carcinogen.

Continued use of the Carina ventilators in pediatric patients could result in serious adverse health consequences, including exposure to hazardous chemicals, toxic reactions and death.

The recall affects 703 devices with distribution dates of March 16, 2009, to October 30, 2023, and part number 5704110, UDI number 04048675398516, all serial numbers.

There have been no reported deaths, complaints or incidents associated with this issue, according to the FDA.

The Carina sub-acute care ventilator is used for people who require full or partial breathing assistance from a mechanical ventilator in a hospital. It can be used for invasive or non-invasive ventilation.

This is the third serious recall of Draeger’s ventilators in recent months. In July, the company’s Oxylog3000 plus emergency and transport ventilators were recalled due to stopped ventilation from depleted batteries. Draeger’s Seattle Positive Airway Pressure (PAP) Plus were recalled in May because glued connections may loosen before or during ventilation due to a manufacturing error. MassDevice