The Food & Drug Administration (FDA) on July 17 identified the recall by Teleflex of its Neonatal ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column as Class I, the most serious.
The recall was initiated because of complaints of cracks in the swivel wye adaptors, which may cause breathing distress because the gas may leak and not reach the patient. Breathing distress from insufficient oxygenation could result in serious adverse patient consequences including death.
The company received two complaints about cracks in the adaptor. No injuries or deaths have been reported.
Distribution dates were December 2018 to January 2019.