FDA designates Draeger Medical Carina Sub-Acute Care Ventilator recall as class I

Key takeaways:

• The FDA designated the recall of Draeger Medical’s Carina Sub-Acute Care Ventilator in pediatric patients as class I.
• The ventilators can still be used in adult patients as long as certain conditions are met.

The FDA has designated Draeger Medical’s recall of its Carina Sub-Acute Care Ventilator for pediatric patients as a class I recall, the most serious kind.

Notably, Draeger Medical reported that they will update/correct the devices included in the recall rather than remove them, according to the FDA alert.

The alert notes that hospitalized patients who need a mechanical ventilator for breathing support use this device.

The ventilators were recalled among pediatric patients because of contaminants, such as polyether polyurethane, in the device’s airpath that can reach undesirable levels if the device is used for more than 30 days. If used, patients could experience hazardous chemicals exposure, toxic reactions and death, according to the FDA alert.

The recall is for 703 devices in the United States, according to the alert.

There are currently no incidents or deaths, Draeger Medical reported to the FDA.

Draeger Medical sent users an Urgent Medical Device Recall letter in July 2023, saying that the ventilator can still be used in adult patients as long as the set minute volume is over 3.6 L per minute, a Draeger ventilator hose with leak valve is used and an inline bacterial filter is used as indicated in the instructions.

As Healio previously reported, the FDA issued a different class I recall to Drager Medical last month for its Oxylog 3000 Plus Emergency and Transport Ventilator.