Cardinal Health (NYSE:CAH)
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Cardinal Health Inc. (CAH) has issued an urgent safety alert warning of a potential risk for improper dosing of medication with one of its infusion modules.

The voluntary alert, dated Tuesday, marks another glitch for the medical supply company's line of Alaris products, some of which have undergone recalls and prompted government action in recent years. It comes three weeks after Cardinal said it reached an agreement with the U.S. Food and Drug Administration to conduct a thorough review of its broad line of infusion pump products, based on an FDA finding that certain pumps do not meet safety standards of the Federal Food, Drug and Cosmetic Act.

Cardinal identified the potential risk after investigating two inquiries on the issue from customers, spokesman Troy Kirkpatrick said Wednesday. The company expects to include the planned software update to fix the problem in a larger corrective action plan due in late April under its recently amended agreement with the FDA covering the company's infusion pump products, he said.

Cardinal shares recently traded down $3.00, or 9.46%, at $28.70.

The new safety alert notification, posted on Cardinal's Web site, informs of a potential risk when the Alaris PCA (patient controlled analgesia) module, model 8120, is used with the Alaris PC unit, models 8000 and 8015, with software versions 8 through 9.1.

"The Alaris PCA module can potentially infuse above or below the intended infusion dose" when all of five specific events occur, including use of an optional therapy feature in the software and a clinician's ignoring warnings on the display, the company said.

No death has resulted from this potential risk, according to Cardinal's Web site. Cardinal detailed actions required for users of the Alaris PCA module and the Alaris PC unit.

Cardinal, a major drug wholesaler and medical supplier, is sending a letter to each affected Alaris customer, distributor and third-party service provider, and offering a support center and instructions for addressing the potential risk.

Cardinal infusion pumps other than the Alaris PC unit and Alaris PCA module are not affected by the safety alert, the company said. Products not covered by the new alert include the Alaris SE pump, Alaris pump module, Gemini infusion pump, Alaris syringe module and MedSystem III pump, the company said.

Cardinal last month said it had reached an agreement with the FDA on an amended consent decree regarding its infusion pump products. The company has operated under the decree since February 2007 for its Alaris SE pumps.

Under the amended agreement, Cardinal said it would conduct a thorough review of its broader line of infusion pump products and submit a corrective action plan to the FDA that outlines all planned modifications to infusion pump products.

The FDA alleges in the amended consent decree that a January 2008 inspection showed certain Cardinal infusion pumps do not meet federal safety standards, according to Cardinal. The amended agreement, however, doesn't affect Cardinal's ability to sell its infusion pump products, other than the Alaris SE pump.

In 2006, Cardinal recalled its Alaris SE infusion pumps, which were designed to give controlled amounts of medications or other fluids to patients intravenously, because of a defect in some pump keypads that could cause overinfusion. The keypads sometimes registered numbers twice when pressed only once. The FDA seized problematic Alaris SE pumps at the company's facility and, at the time, noted that overinfusion could potentially cause serious harm or death in a patient. Cardinal suspended production of the Alaris SE pumps.

Separately, in 2007, Cardinal voluntarily recalled its Alaris pump modules shipped before Sept. 27 that year, citing a potential for an inaccurate flow rate that could cause a patient to receive too much intravenous medication.

-By Dinah Wisenberg Brin, Dow Jones Newswires; 215-656-8285; dinah.brin@dowjones.com