Teleflex is recalling the Neonatal ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column due to complaints of cracks being observed, prior to use, on swivel wye adaptors, a part of the device, reports the Food and Drug Administration (FDA).
Cracks in the adapter may cause breathing distress because the gas may leak and not reach the patient. Breathing distress from insufficient oxygenation could result in serious adverse health consequences including death.
The Neonatal ConchaSmart Breathing Circuits are intended for neonatal and infant patients requiring 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 professional healthcare setting. The circuit also includes heated wires for use with the Hudson RCI Neptune Heated Humidifier. The heated wires are used to help maintain the set patient temperature and minimize condensation in the ventilator tubing.
Teleflex said it received two complaints about cracks in the adaptor, but that 32 percent of adaptors are expected to exhibit cracks. No injuries or deaths have been reported. On May 10 2019, Teleflex sent customers an Urgent Medical Device Recall letter instructing customers to immediately discontinue use and quarantine any affected products in inventory.
Product Codes: 870-07KIT, 870-09KIT
Lot Numbers: 74L1802044, 74L1802045
Manufacturing Dates: November 2018
Distribution Dates: December 2018 to January 2019
