The US Food and Drug Administration (FDA) has classified Draeger Medical’s recall of Oxylog 3000 Plus Emergency and Transport Ventilators as a Class 1 recall.
The Class 1 recall is said to be the most serious type of recall and use of these devices can lead to serious injuries or death.
Germany-based Draeger Medical has recalled the Oxylog 3000 Plus Emergency and Transport Ventilators over the potential risk of unexpected depleted battery and ventilator stop.
The product is designed for patients who need full or partial breathing assistance from a mechanical ventilator. It is also used by medical workers to move patients on ventilators across the hospital and recovery room as well as during patient transport in an ambulance or plane.
The medical products maker received complaints that the Oxylog 3000 Plus Emergency and Transport Ventilator stopped ventilating due to a low battery, even after being reconnected to AC power.
When plugged in, the ventilator might not instantly convert back to AC power and continue using the battery until it is depleted. Eventually, it will stop offering ventilation.
With this issue, a battery alert with the messages “Charge int. battery” and “Int. battery discharged” does occur.
Draeger is recalling 300 of these ventilators which were distributed between 30 April 2012 to 13 June 2022.
According to the FDA, stopped ventilation can cause difficulty breathing, slow heartbeat, lack of oxygen, a sudden stop of the heart or death.
As of now, the medical products maker has received six complaints, no injuries, and no deaths related to this issue.
In a separate development, Aziyo Biologics has announced a voluntary recall of its viable bone matrix products, used primarily in orthopaedic and spinal procedures.
The recall was based on post-surgical Mycobacterium tuberculosis (MTB) infections. It was found in a pair of patients treated with viable bone matrix products from a single donor lot.
Aziyo Biologics president and CEO Randy Mills said: “We are taking immediate action to safeguard patients by implementing a full product recall as we work with the CDC to investigate this event.
“The people of Aziyo care deeply about the patients we serve and will continue to work with the medical community, patients, and regulatory authorities as we gather additional information.”
