On August 25, 2006, the U.S. Marshals seized several lots of Cardinal 303's SE Gold infusion pumps located at the company's manufacturing facility in San Diego, California. The seizure was intended to ensure that the infusion pumps are not distributed unless the problem is corrected. Cardinal 303 voluntarily suspended production, sales, repair, and installation of SE infusion pumps following the seizure.

On August 15, 2006, the company also voluntarily initiated a field corrective action for all SE infusion pumps, which consisted of sending letters and warning labels to its customers concerning the "key bounce" problem. The FDA has classified this action as a Class I recall (a situation where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death). A copy of the company's letter to customers is available on the company's website at www.cardinalhealth.com/alaris.


FDA previously issued warning letters to the company, outlining deviations from the CGMP requirements and QS regulation. The company was given opportunities to correct the violations, but failed to take appropriate actions.

After corrective actions under the decree are completed and Cardinal 303 has been allowed to resume manufacturing and distribution, the firm will hire an independent auditor to conduct audit inspections of its SE infusion pump facilities at least once a year for no less than four years. Results of these audit inspections will be reported directly to FDA. If Cardinal 303 fails to comply with any provision of the decree, or violates the Act or FDA regulations, FDA may order the firm to again cease manufacturing and distributing, recall the products, or take other action.

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