Z-0346-2018 Class I Terminated
FDA device recall Z-0346-2018 was initiated by Vyaire Medical on Nov 29, 2014 and is designated Class I. 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… The recall status is terminated (terminated Feb 5, 2021). Affected quantity: 16,670 units in total.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 31, 2018
- Initiation Date
- Nov 29, 2014
- Termination Date
- Feb 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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
Code Information
0001100127 0001116871 0001116872 0001124936 0001129065 0001129066 0001129067 0001129069 0001129070 0001131426 0001131428 0001134350 0001135400 0001136027 0001136028 0001136029 0001145151 0001145152 0001145153 0001157125
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0346-2018
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026