The issue involves accessory adapters that may loosen during setup or use. Users are advised to stop using the affected connections and monitor ventilation systems closely.

AirLife and manufacturer Vyaire are recalling certain infant heated wire circuits due to the risk that accessory adapters provided with the product may unintentionally disconnect during setup or use when the circuit reaches operating temperature.

The use of the affected product may cause serious adverse health consequences, including hypoxia, hypercapnia, organ failure, and death. To date, Airlife and Vyaire have reported no serious injuries or deaths associated with this issue, according to a medical device recall notice from the US Food and Drug Administration.

AirLife infant heated wire circuits are used during ventilation support to warm breathing gases before they enter a patient’s airway. They are used in neonatal and infant patients and function as a conduit for respiratory gas between the patient and a ventilator.

This recall involves removing certain devices from where they are used or sold. 

What to Do

AirLife and Vyaire are instructing customers not to use the affected devices with the adapter connections from the accessory bag of the AirLife infant heated wire circuit. Immediately stop using any devices that are connected using these adapters. If the adapter connection is not being used with the device, you may continue to use it. 

On April 10, AirLife and legal manufacturer Vyaire sent all affected customers an Urgent Medical Device Recall letter recommending the following actions: 

  • Examine inventory for affected lots. 
  • Quarantine all affected product. 
  • Make sure all affected personnel are aware of this recall notification. 
  • For in-use products:
    • Stop use of affected product if adapter connections are used in the circuit.
    • Continue using affected product if the adapter connections are NOT being used with the device. 
    • Perform frequent checks on ventilator settings, tubing, and connections to ensure they are firmly tight, secure, and functioning properly. 
    • Make sure all alarms for pressure, flow, and disconnection are activated and monitor the patient’s respiratory parameters closely. 
    • Keep backup ventilation and/or manual resuscitation devices should be available at the bedside for emergent situations.
    • Monitor oxygen saturation (Sp02), heart rate, and respiratory rate to make sure clinicians are alerted to any adverse event. 
  • Before use:
    • Test the circuit by blocking the patient connection port and pressure testing it to ensure that there are no leaks.
  • Complete and return the Response Form attached to the letter. 
  • Notify ​​any customers/consignees who may have received affected product.
  • Call AirLife directly at 1-800-433-2797 if replacement products are needed urgently. 

ID 390708004 © Adonis1969 | Dreamstime.com

Medtronic Recalls Certain Newport Ventilators and Related Service Parts