Teleflex is recalling NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column, product codes 870-07KIT, 870-09KIT, as the FDA identified it as class Ⅰ recall.
The breathing circuits are meant for neonatal and infant patients requiring mechanical ventilation, positive pressure breathing assistance, or general medical gases.
A channel for breathing gas between a patient and a ventilator is provided by the circuit in a professional health care setting. It also includes heated wires for use with the Hudson RCI Neptune Heated Humidifier. The heated wires maintain the set patient temperature and minimize condensation in the ventilator tubing.
The company is recalling the Neonatal ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column because of the complaints of cracks being observed, prior to use, on swivel wye adaptors, a part of the device.
Due to the cracks in the adapter breathing distress may be observed because it may lead to gas leakage and not reach the patient. This distress can lead to some serious adverse health consequences including death.
Mr Vinod Arora, Principal Advisor, IGMPI
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