Vyaire Medical: Medical Device Recall in 2018 - (Recall #: Z-0343-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: November 29, 2014

Date Posted: January 31, 2018

Recall Number: Z-0343-2018

Event ID: 78636

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.

Status: Terminated

Product Quantity: 16,670 units in total

Code Information:

CM17H12 CM17H16 CM17H17 CM17H19 CM17H20 CM17J27 CM17J28 CM17J29 CM17J30 CM17K09 CM17K20 CM17K21 CM17K22 CM17K23

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated