The previously announced recall on the CareFusion AirLife(TM) Infant Breathing Circuit has been classified as a Class I recall by the Food and Drug Administration.
A Class I recall indicates that use of the device or drug could cause serious injuries or death to patients. There are no reported adverse events linked to the use of the CareFusion AirLife(TM) Infant Breathing Circuit. The initial recall was announced on May 29. It affected products manufactured between June 1, 2011, and Feb. 3 of this year. The action was necessary because the “Y-adapter in affected products could develop cracks during patient use, potentially resulting in a leak in the closed ventilation system and leading to a loss in the intended tidal volume delivered to the patient.”
Since the recall was announced more than a month ago, just half of the customers have completed the remediation process to return the affected product, according to a release from CareFusion. Customers were asked to return or destroy any AirLife Infant Breathing Circuit units that were included in the announcement in May.
CareFusion sent each of its customers a letter at the time of the recall and included in that announcement was information relevant to Lot numbers and product codes that would help any health care professional identify recalled units.