FDA issues two class I recalls involving ventilators

Key takeaways:

• The FDA designated recalls of ventilation products from Draeger Medical and NOxBOX as class I.
• No injuries or deaths have been reported with use of either device.

The FDA has issued class I recalls, the most serious kind, for two different ventilators.

The first recalled product is the Oxylog 3000 Plus Emergency and Transport Ventilator (Draeger Medical) that is designed for use when clinicians are moving a patient that needs breathing assistance, according to the FDA alert.

The devices were recalled because of six complaints of a depleted battery that terminates ventilation and does not resume ventilation when reconnected to AC power. According to the alert, two alarms have appeared: “Change int. battery” and “Int. battery discharged.”

If ventilation is cut off from a patient, the FDA alert warns of the possibility for several adverse outcomes, including respiratory distress, hypoxia, slow heartbeat, cardiopulmonary arrest and death.

The recall is for 300 devices in the United States, according to the alert. The affected units were distributed from April 30, 2012, to June 13, 2022.

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

Draeger Medical sent users an Urgent Medical Device Recall letter in June 2023, alerting them to not detach the device from the main power supply when they replace the battery and to make sure they perform the correct switchover process outline in the FDA alert.

The second recalled ventilation product is the NOxBOXi Nitric Oxide Delivery System (NOxBOX) that is approved for newborns/neonates with congenital heart disease. Patients using this product receive inhaled nitric oxide therapy via a ventilator and have their nitric oxide, nitrogen dioxide and oxygen levels monitored, according to the FDA alert.

The devices were recalled because of “misalignment of the check valve in the device’s manifold,” and the FDA alert wrote that failure of the manifold could result in nitric oxide or oxygen leakage that disturbs the therapy.

Desaturation, elevated pressure in the pulmonary artery, serious injury or death are several potential adverse outcomes that may occur due to this issue, according to the alert.

The recall is for 767 devices in the United States, according to the alert. The affected units were distributed from May 21, 2021, to Feb. 27, 2023.

There are currently no injuries or deaths, NOxBOX reported to the FDA.

NOxBOX sent users an Urgent Medical Device Recall letter in May 2023. This letter features troubleshooting instructions and instances that signal when a device should not be used, which are all outlined in the FDA alert.

Reference:

• NOxBOX Ltd. recalls NOxBOXi Nitric Oxide System for manifold failure that may cause gas leaks and interrupt therapy to neonates. https://www.fda.gov/medical-devices/medical-device-recalls/noxbox-ltd-recalls-noxboxi-nitric-oxide-system-manifold-failure-may-cause-gas-leaks-and-interrupt. Published July 13, 2023. Accessed July 14, 2023.