Cardinal Health, FDA Amend Infusion Pump Consent Decree
DUBLIN, Ohio, Feb. 17 /PRNewswire-FirstCall/ -- Cardinal Health today
announced it has reached agreement with the Food and Drug Administration (FDA)
on an amended consent decree regarding the company's infusion pump products.
Cardinal Health has operated under a consent decree since February 2007
for its Alaris(R) SE pumps, which resulted in the company implementing a new
quality system on April 2, 2008. Under the amended agreement, which is subject
to approval by the U.S. District Court for the Southern District of
California, Cardinal Health will conduct a thorough review of its broader line
of infusion pump products within 60 days and submit a corrective action plan
to the FDA that outlines all planned modifications to any infusion pump
products. Within 100 days, the company will have an independent expert inspect
and certify whether the company's infusion pump operations are in conformity
with the Quality System Regulation and certain other provisions of the Federal
Food, Drug, and Cosmetic Act. Also within 100 days, the company will have an
independent expert inspect and certify whether its recall procedures and all
ongoing infusion pump recalls are in compliance with the Act and determine
whether additional remedial action should be taken.
The FDA alleges in the amended consent decree that based on a January 2008
inspection, certain Cardinal Health infusion pumps do not satisfy the
standards of the Act. The amended agreement does not impact the company's
ability to market and sell its broader line of infusion pump products, except
for the Alaris SE pump.
"We are taking the FDA's observations -- and our obligation to deliver
safe and effective products -- very seriously," said David Schlotterbeck,
Cardinal Health vice chairman and chief executive officer of Clinical and
Medical Products. "We will continue to improve our systems as we prepare to
meet the additional requirements of the amended consent decree."
Customers using Alaris(R) brand infusion products who have questions about
this announcement should contact 1-800-625-6627 or
SupportCenter@cardinalhealth.com.
About Cardinal Health
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a $91
billion, global company serving the health care industry with products and
services that help hospitals, physician offices and pharmacies reduce costs,
improve safety, productivity and profitability, and deliver better care to
patients. With a focus on making supply chains more efficient, reducing
hospital-acquired infections and breaking the cycle of harmful medication
errors, Cardinal Health develops market-leading technologies, including
Alaris(R) IV pumps, Pyxis(R) automated dispensing systems, MedMined(TM)
electronic infection surveillance service, VIASYS(R) respiratory care products
and the CareFusion(TM) patient identification system. The company also
manufactures medical and surgical products and is one of the largest
distributors of pharmaceuticals and medical supplies worldwide. Ranked No. 19
on the Fortune 500, Cardinal Health employs more than 40,000 people on five
continents. More information about the company may be found at
http://www.cardinalhealth.com.
