CareFusion ($CFN) is facing its third Class I recall in two months.
The San Diego maker of medical devices--including drug infusion pumps, ventilation and respiratory products--is well under way with recalling the PC unit and corresponding power supply cord of its Alaris electronic infusion pump. That's because a component of the power supply board keeps sending bogus error messages and triggering an alarm, preventing caregivers from programming the infusion pump. The FDA explains in its Aug. 1 posting of the recall that the action could delay vital treatment or prevent caregivers from making any changes to current programming, which puts the patient at serious risk.
The latest recall began May 25, and, according to the FDA, CareFusion sent an urgent medical device recall notice to affected customers. There is only one affected PC unit and a single PC unit power supply board, both of which were manufactured between Jan. 1, 2011 and May 31, 2012. The company has said it would contact affected customers within 60 days of receiving the letter, after which it will schedule a visit to replace the affected parts. A Class I recall is the agency's most serious label.
In late July, the FDA hit CareFusion with a Class I recall regarding its EnVe ventilators. The company had begun a voluntary recall of certain models after learning that some could be susceptible to leaks and possible ventilator failure. Earlier in the month, the company announced a recall certain models of its AirLife infant breathing circuit devices, warning that they could crack and leak, causing a dangerous decrease in tidal volume to the patient. The FDA designed the action a Class I recall soon after.
CareFusion plans to release fiscal 2012 fourth-quarter and year-end results Aug. 9.
- read the FDA recall notice
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