CareFusion ($CFN) has recalled certain models of its AirLife infant breathing circuit devices, warning that they can crack and leak, leading to a dangerous decrease in tidal volume to the patient, Reuters reports. The company notified customers on May 29, and the FDA has designated the affair a Class I recall.
The recall applies to the Y models of the device, of which there are about 280,000, manufactured between June 1, 2010 and Feb. 3, 2012, the company said. So far, CareFusion has received no reports of patient harm from the faulty breathing techs, and the company said it has since reformed its manufacturing process to prevent the cracking issue from cropping up again.
CareFusion is advising AirLife customers to destroy the techs, and the company told Reuters that about half of the affected devices have been disposed of.
The Class I recall--the FDA's most serious designation--is another spot of bad news for CareFusion. Last month, the company may have fallen victim to hacking, as the site that updates software for its ventilators was loaded with malware. Previously, the company saw its profits dip following the sale of its neurodiagnostic unit, but CareFusion brass says the business is healthy and considering M&A. And the market would seem to agree: CareFusion closed at nearly $26 a share yesterday, a high it hadn't reached since early May.
- read the recall notice
- here's Reuters' report