The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning its NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column, manufactured by Teleflex. The affected devices are identified as the following:-
The manufacturer is recalling the affected products due to complaints of cracks being observed, prior to use, on swivel wye adaptors, a part of the device.
According to the manufacturer, 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 manufacturer received two complaints about cracks in the adaptor. Thirty-percent of adaptors are expected to exhibit cracks. No injuries or deaths have been reported.
The manufacturer sent users an Urgent Medical Device Recall letter, which instructed users to immediately discontinue use and quarantine any affected products in inventory.
Product recall is on-going.
For details, please refer to the following FDA website:
https://www.fda.gov/medical-devices/medical-device-recalls/teleflex-recalls-neonatal-conchasmart-breathing-circuit-due-circuit-cracks
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 July 2019