CareFusion Provides Update On Voluntary Recall Of Select AirLife Respiratory Products

CareFusion CFN issued the following update regarding its voluntary recall of its AirLife™ Infant Breathing Circuit. The FDA has classified this action as a Class 1 recall. The company initiated the voluntary recall on May 29. The products subject to the recall were manufactured between June 1, 2010, and Feb. 3, 2012. This action has no effect on the manufacture or distribution of current products. In May 2012, the company sent an urgent Recall Notification to customers and distributors stating the identified potential risks associated with the AirLife Infant Breathing Circuit. 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. A Class I recall is defined as 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. There is no change to the remediation plans previously announced by the company. In the notification letter, customers were provided lot numbers of affected product codes and asked to destroy any affected products remaining in inventory.