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Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidification...

FDA Recall #Z-0344-2018 — Class I — November 29, 2014

Recall #Z-0344-2018 Date: November 29, 2014 Classification: Class I Status: Terminated

Product Description

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 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.

Recalling Firm

Vyaire Medical — Vernon Hills, IL

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product Quantity

16,670 units in total

Distribution

US Nationwide Distribution

Code Information

0001115635 0001115640 0001124941 0001124942 0001124943 0001124944 0001129628 0001134758 0001134759

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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