DUBLIN, Ohio — Cardinal Health spinoff CareFusion will resume shipments of its most important drug-delivery pumps that had been stopped over a software glitch, the company said Friday.
Cardinal stopped shipping and in June issued a recall on more than 180,000 combined Alaris PC units and PCA (Patient Controlled Analgesia) modules. Patients use the devices to get their medications through the touch of a button. But a software error could potentially deliver either less medicine than required or an overdose.
The recall could cost up to $18 million — an amount set aside by CareFusion earlier in the year — and it cost the company an estimated $11 million in sales during its recent fiscal third quarter, which ran from the beginning of 2009 through March, according to its SEC filings.
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Now, though, the company can start shipping after it received a 510(k) clearance from the U.S. Food and Drug Administration.
The company is still operating under an FDA consent decree for other Alaris pumps.
