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CareFusion Issues Update on Infant Breathing Product Recall


July 5, 2012 — Medical device maker CareFusion has issued an update reminding healthcare providers of its voluntary recall of its AirLife™ Infant Breathing Circuit, initiated back in May.
The US Food and Drug Administration (FDA) has classified this action as a class 1 recall, meaning there is a reasonable probability of serious adverse health consequences or death associated with use of the defective units.
The update was posted July 2 on the FDA Website.
On May 29, 2012, CareFusion sent an Urgent Recall Notice to customers and distributors stating that the company had identified potential risks associated with the AirLife Infant Breathing Circuit.
The action was initiated after the company received complaints of the Y adapter within the breathing circuit developing 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," the letter reads.
To date, there have been no reports of patient harm associated with the affected products, the company says.
There is no change to the remediation plans previously announced by the company. The notification letter contains a complete list of affected product code lot numbers, and asks customers to destroy any affected products remaining in inventory.
The products subject to the recall were manufactured between June 1, 2010, and February 3, 2012.
Since the recall was initiated May 29, 2012, nearly half of the affected customers and distributors have completed the remediation process, the company says.
Questions related to this action should be addressed to CareFusion Customer Service atCustomer.Experience@carefusion.com.

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