The FDA slapped CareFusion ($CFN) with its second Class I recall in as many months, this time over the company's EnVe ventilators.
CareFusion voluntarily recalled certain models of the respiratory devices after discovering that they may be prone to leaks that could result in the ventilators failing to maintain the proper pressure, the company said. When this happens, the device will set off alarms to notify physicians that ventilator pressure may be compromised.
The company sent a letter to hospitals and other customers in June, and, last week, the FDA designated the recall a Class I, the agency's most serious label. CareFusion said it has not received any reports of patient harm related to EnVe devices.
The recall affects only models manufactured between December 2010 and January 2012, the company said, and it comes on the heels of a Class I recall of CareFusion's AirLife infant breathing circuit devices, which were also prone to leakage. Earlier this month, the company said that about half of the recalled AirLife devices had been identified and destroyed.
As Zachs.com reports, the continued concern over CareFusion's production quality is something investors will certainly note. And the company's woes aren't limited to hardware: In June, CareFusion shut down a website that updates software for its ventilators when the page was overrun with malware and viruses.