CareFusion hit with another Class I recall over pump

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CareFusion is recalling models of its Alaris infusion pump over the risk that their keypad covers may come loose--courtesy of CareFusion

CareFusion's ($CFN) summer of regulatory discontent isn't over yet, and the company is in the midst of its fourth Class I recall since June. This time, it's due to a keypad malfunction in the Alaris infusion pump that could lead to injury or death.

CareFusion informed its customers on July 20 that the protective keypad overlay on the door of the Aleris model 8100 had a habit of coming loose, exposing the keys to liquids and risking pump shutdown. The affected units were manufactured  from October 2011 to February 2012, the company said.

When infusion stops, any patients using the device risk injury or death, the FDA said, and the agency on Tuesday tagged the recall with its most serious designation. The FDA is urging health professionals and patients to report adverse events related to the pump through its online MedWatch system.

This isn't the first spot of trouble for CareFusion's Alaris line of pumps. Earlier this month, the company staged a Class I recall of Alaris PC units, model 8015, warning that a faulty power supply could interrupt functionality. Prior to that, the company recalled EnVe and AirLife, two ventilators slapped with Class I tags. And if the scrutiny over its hardware safety wasn't enough, CareFusion faced a software hacking risk in June when the website used to update its ventilator CPUs got overrun with malware.

Despite all that, CareFusion reported a 29% year-to-year jump in net profit last quarter and, most encouragingly, a 29% sales spike for respiratory products. The earlier recalls cost the company $7 million on the quarter, CFO Jim Hinrichs told investors.

- read the FDA's recall notice
- check out the letter CareFusion sent to customers (PDF)
- get Reuters' take

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CareFusion hit with Class I recall of infusion pump component
CareFusion hit with another Class I ventilator recall