Teleflex (NYSE:TFX) is recalling its Neonatal ConchaSmart breathing circuit with dual heated limb and ConchaSmart Column due to complaints of cracks being observed, prior to use, on the device’s swivel wye adaptors.
Cracks in the adaptor may cause breathing distress from insufficient oxygenation because the gas may leak and not reach the patient. The FDA has termed it a Class I recall, as insufficient oxygenation may result in injury or death.
Teleflex received two complaints about cracks in the adaptor, according to the agency. Thirty percent of adaptors are expected to exhibit cracks. The company alerted customers beginning in May. No injuries or deaths have been reported.
The recall includes 300 devices manufactured in November 2018 and distributed between December 2018 and January 2019.
The Neonatal ConchaSmart breathing circuits are intended for neonatal and infant patients who need mechanical ventilation, positive pressure breathing assistance, or general medical gases. The circuit provides a channel for breathing gas between a patient and a ventilator in a healthcare setting. The circuit also includes heated wires for use with the Teleflex’s Hudson RCI Neptune heated humidifier. The heated wires are used to help maintain the set patient temperature and minimize condensation in the ventilator tubing, according to the company.
This is the second Class I recall for Teleflex that FDA has reported within the past month. Two deaths were reported in a recall of 6 million Teleflex endotracheal tubes in June.
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