The Recall Desk

FDA (Devices) recall action 78636

Vyaire Medical recalled 4 products on 2018-01-31

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2018-01-31
Critical
0
Units
66,680

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • HighFDA (Devices)··2018-01-31

    Vyaire Medical Recalls AirLife Humidification Chambers Due to Overflow Risk

    Vyaire Medical is recalling 16,670 AirLife Humidification Chambers and circuits because a manufacturing error may cause water to back up into patient airways.

    Product
    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-01-31

    Vyaire Medical Recalls Infant AirLife Humidification Chambers Due to Overflow Risk

    Vyaire Medical is recalling 16,670 Infant AirLife single-limb circuits and humidification chambers because a manufacturing error may cause water to back up into the patient's airway.

    Product
    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 gas
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-01-31

    Vyaire Medical Recalls Adult Air-Life Single-Limb Circuits Due to Overflow Risk

    Vyaire Medical is recalling 16,670 units of Adult Air-Life single-limb circuits with Humidification Chambers due to a manufacturing error that may cause water overflow into patient airways.

    Product
    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 requiri
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-01-31

    Vyaire Medical Recalls Infant AirLife Humidification Chamber Due to Overflow Risk

    Vyaire Medical is recalling 16,670 Infant AirLife humidification chambers because a manufacturing error may cause water to overflow into the patient's airway.

    Product
    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 gasse
    Category
    Distribution
    0 states