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U.S. Department of Health and Human Services

Safety

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CareFusion Airlife Infant Breathing Circuit: Class I Recall - Potential for Leak in Closed Ventilation System

 

[Posted 07/06/2012]

AUDIENCE: Anesthesiology, Risk Manager

ISSUE: FDA notified healthcare professionals of the Class 1 recall of the Airlife infant breathing circuit due to the risk that the Y-adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient. These products may cause serious adverse health consequences, including death. The recalled products were distributed from July 1, 2010 through May 7, 2012.

See the Recall Notice for a listing of affected lot numbers.

BACKGROUND: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.

RECOMMENDATION: On May 29, 2012, the firm sent an Urgent Recall Notice to customers and distributors. The distributors were requested to immediately destroy any affected product in-stock at their facilities and to cease distributing these products. They were also requested to forward the recall notice to any customers to whom these products were sold, notifying them of the potential risk. CareFusion is requesting that customers destroy all affected product or return any unused product to the distributor.

[07/06/2012 - Recall Notice - FDA]
[05/29/2012 - Urgent Recall Letter disclaimer icon - CareFusion]