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U.S. Department of Health and Human Services

Safety

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Alaris SE Infusion Pumps

Audience: Healthcare administrators, risk managers, and healthcare professionals

[UPDATE 09/26/2006] Recall classified as Class I. The manufacturer provided recommendations to users for safe operation of the product. FDA provided Q&As.

[Posted 08/29/2006] FDA and Alaris Products notified healthcare professionals of a recall of defective infusion pumps due to a design defect called "key bounce" that may cause potential over-infusion of medications and result in an infusion rate at least 10 times the intended infusion rate. Infusion pumps are electronic devices intended for controlled delivery of intravenous solutions and medications to patients. Key bounce occurs when a number pressed once on the pump registers twice and not detected during programming verification. The products included in this recall (model numbers 7130,7131, 7230, and 7231) are distributed by Cardinal Health Care 303 Inc. The manufacturer provided recommendations to pump users on steps they can take to minimize key entry errors until the problem can be corrected. Healthcare facilities can continue to use pumps in their possession, guided by the company's instructions.

[September 26, 2006 - Recall Notice - FDA]
[September 26, 2006 - Questions and Answers - FDA]

[August 28, 2006 - Press Release - FDA]
[August 15, 2006 - Recall Letter - Alaris Products]