* 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 (Reuters) - 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 spokeswoman said.
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.