Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber, Mod...
FDA Device Recall #Z-0346-2018 — Class I — November 29, 2014
Recall Summary
| Recall Number | Z-0346-2018 |
| Classification | Class I — Serious risk |
| Date Initiated | November 29, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Vyaire Medical |
| Location | Vernon Hills, IL |
| Product Type | Devices |
| Quantity | 16,670 units in total |
Product Description
Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.
Reason for Recall
Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the ventilated patient.
Distribution Pattern
US Nationwide Distribution
Lot / Code Information
0001100127 0001116871 0001116872 0001124936 0001129065 0001129066 0001129067 0001129069 0001129070 0001131426 0001131428 0001134350 0001135400 0001136027 0001136028 0001136029 0001145151 0001145152 0001145153 0001157125
Other Recalls from Vyaire Medical
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1698-2025 | Class I | Brand Name: AirLife Product Name: AirLife Infa... | Apr 10, 2025 |
| Z-1697-2025 | Class I | Brand Name: AirLife Product Name: AirLife Infa... | Apr 10, 2025 |
| Z-1061-2024 | Class I | AirLife Adult Manual Resuscitator, 40" (1.0m) O... | Jan 10, 2024 |
| Z-1065-2024 | Class I | AirLife Adult Manual Resuscitator, 40" (1.0m) O... | Jan 10, 2024 |
| Z-1060-2024 | Class I | AirLife Adult Manual Resuscitator, Oxygen Reser... | Jan 10, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.