FDA Device recall Z-0345-2018
Adult Air-Life single-limb circuit (Model AH202) 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 Air-Life single-limb circuit (Model AH202) 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-0345-2018 |
| 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 Air-Life single-limb circuit (Model AH202) 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 | 0001115270 0001121993 0001124929 0001 124930 0001 124932 0001129063 0001 129064 0001131424 0001131425 0001 134…0001115270 0001121993 0001124929 0001 124930 0001 124932 0001129063 0001 129064 0001131424 0001131425 0001 134347 0001134348 0001135401 0001135402 0001137252 0001137253 0001139266 0001139267 0001145147 0001145148 0001145149 0001156843 |
|---|
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-0345-2018%22
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