Z-0345-2018 Class I Terminated
FDA device recall Z-0345-2018 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 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 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
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0345-2018
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026