FDA issues Class I recall on infant heated wire circuits prone to disconnect
The U.S. Food and Drug Administration (FDA) announced a recall on certain heated wire circuits—in this case used on infants—due to a risk they may unintentionally disconnect. The devices are used during ventilation to warm breathing gases, making it easier for patients to respirate without the risk of becoming too cold.
Per the FDA notice, these infant heated wire circuits are manufactured by Vyaire, under the brand name Air Life. The issue stems from a faulty adapter that can cause disconnection during setup or once the circuits reach operating temperature.
To date, there have been no reported injuries. However, due to the high risks associated with this defect—including low oxygen, carbon dioxide buildup, and, subsequently, organ failure or death—this recall has been designated a Class I, the FDA’s most serious type.
What is being recalled?
The AirLife units' accessory bag contains the adapter that’s subject to this recall, a photo of which can be seen above. Multiple lines of product kits have been impacted. Here are the details:
- Name: AirLife Infant Heated Wire Circuit dual-limb dual-heat, highflow circuit (>4L/min)/AH165
- Individual UDI: 10889483595862
- Case UDI: 30889483595866
- Name: AirLife Infant Heated Wire Circuit dual-limb dual-heat, highflow circuit (>4L/min)/AH165 (Vyaire)
- Individual UDI: 10190752145139
- Case UDI: 50190752145137
- Name: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, high-flow circuit (>4 L/min), Contains AH165 and Circuit, AH290 Chamber/AH265
- Individual UDI: 10889483595909
- Case UDI: 30889483595903
- Name: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, high-flow circuit (>4 L/min), Contains AH165 and Circuit, AH290 Chamber/AH265 (Vyaire)
- Individual UDI: 10190752145160
- Case UDI: 50190752145168
For affected lot numbers, view the FDA recall notice by clicking here.
Next Steps
The adapters from the kits above are not to be used with the AirLife Infant Heated Wire Circuit under any circumstances. However, it is safe to use the circuits without the adapter.
AirLife and Vyaire sent an Urgent Medical Device Recall letter to all known customers, alerting them to the disconnection issue, on April 10. They instruct all suppliers, providers and hospitals to check inventory for any recalled devices. If identified, the adapters must be quarantined immediately.
If they are currently being used on patients, constant safety checks are necessary to ensure they are working properly, and clinicians should have backups and manual resuscitation devices on hand.
Defective products can be returned using the response form in the letter. For more information or to obtain immediate replacements, contact AirLife at 1-800-433-2797.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.