CareFusion has issued an update following its voluntary recall of its AirLife™ Infant Breathing Circuit. The FDA has classified this action as a Class 1 recall, which can be found here.
In May 2012, Carefusion issued an urgent Recall Notification to customers and distributors identifying potential risks associated with the AirLife Infant Breathing Circuit. The company initiated a voluntary recall on May 29 of products manufactured between June 1, 2010, and Feb. 3, 2012. This action has no effect on the manufacture or distribution of current products.
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, although to-date there have been no reports of patient harm associated with the affected products.
In the notification letter, which can be found here, customers were provided lot numbers of affected product codes and asked to destroy any affected products remaining in inventory.
Since the recall was initiated in May, nearly half of the affected customers and distributors have completed the remediation process. More information about the AirLife recall and other product recalls and alerts can be found on the company’s website.
In addition the company separately filed with the Securities and Exchange Commission a Form 8-K in which the company reported an expected increase to its recall reserve of between $7 million for the quarter and fiscal year ended June 30, 2012. This adjustment is primarily related to a voluntary recall affecting the PC unit of certain models of the company’s Alaris® infusion pumps.
Source: Carefusion Corporation, PR Newswire, FDA