Infant breathing device recalled
The FDA is recalling all CareFusion AirLife™ Infant Breathing Circuit devices that have a Y adapter manufactured before February 3, 2012, after receiving complaints that the product developed cracks during patient use.
"If a crack develops in the Y adapter, this could potentially result in a leak in the closed ventilation system, leading to a loss in the intended tidal volume delivered to the patient," CareFusion wrote in an urgent recall notice to distributors.
All lot numbers less than lot #0000414257 or beginning with the letter ‘Y', should be removed from the market, and CareFusion is advising healthcare providers and consumers not to use these products and to destroy any remaining inventory. A full list of the more than 80 different individual product codes is available, here.
All AirLife™ Infant Breathing Circuit devices are equipped with an audible alarm that detects a decrease in the tidal volume delivered. To date, there have been no reports of the alarm failing to sound due to a crack in the Y adapter.
This is a Class I recall, according to the FDA, which is defined as having a reasonable probability of serious adverse health consequences or death associated with use of the defective units. To date, there have been no reports of patient harm associated with the affected products.