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FDAnews Device Daily Bulletin

Teleflex Recalls Neonatal Breathing Systems Following Complaints

July 22, 2019

Teleflex is recalling two lots of its Neonatal ConchaSmart breathing circuits, devices that provide a channel for breathing gas between a patient and ventilator.

The company received two complaints about cracks in the adaptors of the devices meant for neonates and infants that need mechanical ventilation, positive pressure breathing assistance or general medical gases.

The FDA said that thirty percent of adaptors in the affected lots are expected to exhibit the cracks.

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