FDA: Neonatal ConchaSmart Breathing Circuit Device Recalled by Teleflex

The Neonatal ConchaSmart Breathing Circuit has been recalled by the manufacturer, Teleflex, according to a statement released by the US Food and Drug Administration (FDA). The Breathing Circuit is used in neonatal and infant patients who require mechanical ventilation, positive pressure breathing assistance, or general medical gasses.

A total of 300 devices in the United States have been recalled with product codes 870-07KIT and 870-09KIT, and lot numbers 74L1802044 and 74L1802045, manufactured in November 2018.

Teleflex issued a recall in response to reports of cracks on the swivel wye adapters, a part of the device. Cracks could cause breathing distress a result of the gas leaking and not reaching the patient. Insufficient oxygenation could result in serious adverse health events, including death. While no injuries or deaths have been reported, Teleflex noted 30% of adapters are expected to have cracks.

Hospitals and healthcare providers have been instructed to immediately discontinue use of the Neonatal ConchaSmart Breathing Circuit and to report any adverse reactions or quality problems.

Patients and providers may report any adverse reactions or quality issues to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. For more information, please contact Teleflex customer service at 1-866-396-2111.

Reference

Teleflex recalls NEONATAL ConchaSmart Breathing Circuit due to circuit cracks. US Food and Drug Administration. https://www.fda.gov/medical-devices/medical-device-recalls/teleflex-recalls-neonatal-conchasmart-breathing-circuit-due-circuit-cracks. Accessed July 18, 2019.