CareFusion Recalls AirLife Infant Breathing Product
Medical device manufacturer CareFusion issued a recall for its AirLife Infant Breathing Circuit products due to a leaking risk – a recall that regulators are now classifying as a Class I, the most serious warning level.
The Food and Drug Administration classified the recall on June 29 as a Class I, which means a product could cause serious harm or death.
CareFusion initially notified hospitals in May that it was voluntarily withdrawing the products from the market and that they should destroy whatever was left in their inventory.
The recall was issued because the products may develop cracks during use, which could lead to a leak in the closed ventilation system, according to Reuters. Nearly 280,000 of the disposable products included in the recall were manufactured between June 1, 2010 and February 3, 2012.
To date, there have been no reports of patient harm.
If you or a loved one has been harmed by an unsafe medical device, contact Sokolove Law for a free legal consultation and to find out if a product liability lawyer may be able to help you. For legal help, call (800) 581-6358.
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