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Cardinal given class I notice for Alaris recall

This article was originally published in Clinica

Executive Summary

Cardinal Health has again reported faults related to its Alaris electronic infusion pumps, prompting a class I recall notification from the FDA. The agency gave the product the highest possible recall classification after the Dublin, Ohio-based company reported five problems with the system including issues with the occlusion warning message, syringe volume warning message, electrostatic discharge protection security and fluid ingress tubing. The FDA said that these faults may result in serious injury or death caused by over- or under-infusion of medication. Cardinal previously recalled 200,000 Alaris pumps in January 2008 after a defect in the device’s spring was linked to two patient deaths (see Clinica No 1289, p 14). In February 2007, Cardinal reached an agreement with the FDA regarding corrective action over oversensitive keypads used with its Alaris SE line of infusion pumps (see Clinica No 1244, p 7).

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