CLASS I Device recall · Reported 31 Jan 2018 · FDA Enforcement Report
Infant AirLife Dual-,limb, dual-heat, high-flow circuit recalled
Vyaire Medical is recalling Infant AirLife Dual-,limb, dual-heat, high-flow circuit (, distributed nationwide in the US. The recall was initiated on 29 Nov 2014 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0344-2018
- FDA event ID
- 78636
- Recalling firm
- Vyaire Medical, Vernon Hills, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 29 Nov 2014
- FDA classified
- 24 Jan 2018
- Reported
- 31 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Masks, Gloves & PPE
Timeline
| 29 Nov 2014 | Recall initiated by company | |
| 24 Jan 2018 | Classified by FDA | +1152 days |
| 31 Jan 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) 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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Infant AirLife Dual-,limb, dual-heat, high-flow circuit ( recalled?
Yes. Vyaire Medical recalled Infant AirLife Dual-,limb, dual-heat, high-flow circuit ( on 29 Nov 2014. The recall is Class I and its status is Terminated. Recall number Z-0344-2018.
Why was it recalled?
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.
Which lots are affected?
0001115635 0001115640 0001124941 0001124942 0001124943 0001124944 0001129628 0001134758 0001134759
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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