DOW JONES NEWSWIRES

Baxter International Inc. (BAX) said Wednesday the Food and Drug Administration classified what it had called an "urgent device correction" on its Colleague intravenous-fluid pumps as a Class I recall because of "the risk of serious injury or patient death if affected devices malfunction."

The infusion pumps have been a long-running problem for the medical-device maker.

Baxter's shares were down 2 cents at $51.32 in premarket trading.

In a January letter, Baxter notified consumers of failure codes in the pumps that may cause them to stop infusing while delivering medication and fluids to patients. The letter also warned of the possibility of the device's overheating, resulting in smoke and fire.

The FDA's recall, which is its most stringent, includes several model numbers.

-By Kerry E. Grace, Dow Jones Newswires; 201-938-5089; kerry.grace@dowjones.com