CARDINAL HEALTH, FDA REACH AGREEMENT ON ALARIS SE INFUSION PUMPS

Cardinal Health says it has reached an agreement with the FDA on a consent decree regarding the company's Alaris SE line of infusion pumps.

The agreement outlines the process Cardinal Health will follow to resume the manufacture and sale of the devices in the U.S. market, the firm said Feb. 6. The agreement is subject to approval by the U.S. District Court for the Southern District of California.

Under the agreement, the firm must submit a plan to the FDA outlining corrections for the pumps currently in use by customers, submit a remediation plan for the seized pumps and have an independent expert inspect its facilities and certify the firm's operations.

Cardinal Health initiated a voluntary field corrective action of Alaris SE infusion pumps Aug. 15, 2006, after the firm learned that a sensitive keypad posed a risk of "key bounce" that could lead to over-infusing. The firm suspended production, sales and repairs of its Alaris SE infusion pump Aug. 28, 2006, after approximately 1,300 units were seized by U.S. marshals upon the FDA's request (Device Daily Bulletin, Sept. 1, 2006 (http://www.fdanews.com/dailies/device/2_425/news/59656-1.html)).

The full agreement will be posted to the Cardinal Health website upon approval by the district court, the firm said.