* Ventilation product could develop cracks and leak
* Company says has no reports of patients being harmed
* Estimates 280,000 affected products were manufactured
July 2 Medical device maker CareFusion
said it has recalled its AirLife Infant Breathing Circuit
products because they could develop cracks during use, causing a
leak in the closed ventilation system.
About 280,000 of the disposable products being recalled were
manufactured between June 1, 2010 and February 3, 2012, a
CareFusion spokeswoman said.
There have been no reports of patient harm associated with
the products, the company said.
CareFusion has since improved its manufacturing process and
is making a stronger component for its new breathing circuit
products, which attach to a mechanical ventilator, the
The company notified hospitals in late May that it was
removing the AirLife products from the market and advised them
to destroy whatever remained in their inventory. The U.S. Food
and Drug Administration classified the action as a Class I
recall on its website on June 29, meaning the defective units
could cause serious harm to a patient's health.
Since May, nearly half of affected customers and
distributors have either destroyed the items or reported they no
longer have them, CareFusion said.
Shares of CareFusion traded at $25.67 in after-hours trading
after a close of $25.82 on the New York Stock Exchange.