Z-0343-2018 Class I Terminated
FDA device recall Z-0343-2018 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
Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing 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
CM17H12 CM17H16 CM17H17 CM17H19 CM17H20 CM17J27 CM17J28 CM17J29 CM17J30 CM17K09 CM17K20 CM17K21 CM17K22 CM17K23
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0343-2018
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026