ConchaSmart Breathing Circuit Device Recall

Breathing circuit device recall

UNITED STATES – As reported in an online news article published by www.pulmonologyadvisor.com and according to an FDA public health notification, Teleflex, a medical device manufacturer, has recalled its Neonatal ConchaSmart Breathing Circuit following reports of cracking on the swivel wye adapters, posing a risk of harm to patients.

Teleflex’s Neonatal ConchaSmart Breathing Circuit device is used with neonatal and infant patients who require mechanical ventilation, positive pressure breathing assistance, and general medical gasses.  The ConchaSmart provides a “channel” for breathing gas between a patient and a ventilator.  The ConchaSmart includes heated wires used with the Hudson RCI Neptune Heated Humidifier. The heated wires are used to assist in maintaining a set temperature for a patient and to minimize condensation in the ventilator tubing.

According to the United States Food and Drug Administration (FDA), Teleflex has recalled a total of 300 devices distributed in the United States with product codes 870-07KIT and 870-09KIT, and lot numbers 74L1802044 and 74L1802045.  The affected lots were manufactured in November 2018 and distributed between December 2018 and January 2019.

Teleflex recalled the 300 Neonatal ConchaSmart Breathing Circuits following reports of cracking on the swivel wye adapters.  Teleflex received a total of two complaints of cracking, which were observed on the devices before use.  Such cracking can lead to breathing distress as gas can leak and not reach the patient. Insufficient oxygen could lead to severe injuries, such as brain damage, and death.  Teleflex reports that no injuries or deaths have been reported, but that 30% of adapters are expected to have cracking.

Hospitals and healthcare professionals are instructed to immediately discontinue using the Neonatal ConchaSmart Breathing Circuit devices and quarantine all devices in their inventory.  Hospitals and healthcare providers are also instructed to complete an Acknowledgment Form stating whether they have any of the affected ConchaSmart products in their possession.