Cardinal Health Suspends Production of Alaris SE Infusion Pump Following FDA Actions
DUBLIN, Ohio, Aug. 28, 2006 — Cardinal Health announced today that it has suspended production, sales, repairs and installations of its Alaris® SE infusion pump after approximately 1,300 units were seized on Friday by the Food and Drug Administration (FDA).
On Aug. 15, Cardinal Health had initiated a voluntary field corrective action of the product (formerly the Signature Edition® Infusion Pump) as the result of information indicating that a sensitive keypad posed a risk of ‘key bounce’ and could lead to the over-infusing of patients. As part of the field corrective action, Cardinal Health had sent letters and warning labels to its customers and is currently testing a modification that reduces sensitivity of the keypad. This modification will need to be validated on the product and approved by the FDA.
These actions do not require the return of products currently in use by customers.
“The safety of patients is our primary concern and we are cooperating with the FDA as we work to educate customers about the risk of key bounce and make modifications to our product that will help eliminate the risk,” said David Schlotterbeck, CEO of Pharmaceutical and Medical Products for Cardinal Health.
The company said it would resume manufacturing and distribution of the Alaris SE infusion pumps pending resolution of the issue with the FDA.
There have been approximately 140,000 Alaris SE infusion pumps distributed worldwide during the past 12 years and the product line currently represents less than 1 percent of annual revenue for Cardinal Health’s Clinical Technologies and Services segment.
Customers with questions regarding this product can contact Cardinal Health at (877) 552-4922. Other related questions or reports may be addressed to Customer Advocacy at (800) 854-7128, extension 7812 or via e-mail at email@example.com
About Cardinal Health
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is an $81 billion, global company serving the health-care industry with a broad portfolio of products and services. Through its diverse offerings, Cardinal Health delivers health-care solutions that help customers reduce their costs, improve safety and productivity, and deliver better care to patients. The company manufactures, packages and distributes pharmaceuticals and medical supplies, offers a range of clinical services and develops automation products that improve the management and delivery of supplies and medication for hospitals, physician offices and pharmacies. Ranked No. 19 on the Fortune 500, Cardinal Health employs more than 55,000 people on six continents. More information about the company may be found at www.cardinalhealth.com.