Agency classClass IOur severity:Severe FDA (Devices)·Z-0344-2018·Announced 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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"

Plain-English summary

Vyaire Medical is recalling 16,670 units of the Infant AirLife Dual-limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidification Chamber (Model AH290). These devices operate as part of a system for delivering heated and humidified respiratory gases to patients requiring invasive and non-invasive ventilation. The products were distributed nationwide in the United States.

The recall was initiated due to a manufacturing error in the humidification chamber that may cause an overfill or overflow condition. This defect can result in water backing up into the patient circuit, potentially allowing an excessive amount of water to enter the airway or lungs of the ventilated patient.

Healthcare facilities and consumers should stop using the affected units immediately. Vyaire Medical is the recalling firm responsible for managing this safety action.

The recalled product

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…
Manufacturer: Vyaire Medical
Category: Medical Device — Respiratory Equipment
Hazard: aspiration
manufacturing-defect
Affected units: 16,670

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Vyaire Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Vyaire Medical

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Same hazard · aspiration