FDA Device recall Z-0346-2018
Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber, Model Number AH290
- FDA Device
- Class I
- terminated
- Published 2018-01-31
On 2018-01-31 the FDA classified a Class I recall of Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber, Model Number AH290 by Vyaire Medical, citing 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 excess….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0346-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-11-29 |
| Published | 2018-01-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Vyaire Medical |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | 0001100127 0001116871 0001116872 0001124936 0001129065 0001129066 0001129067 0001129069 0001129070 0001131426…0001100127 0001116871 0001116872 0001124936 0001129065 0001129066 0001129067 0001129069 0001129070 0001131426 0001131428 0001134350 0001135400 0001136027 0001136028 0001136029 0001145151 0001145152 0001145153 0001157125 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0346-2018%22
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