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U.S. Department of Health and Human Services

Safety

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Cardinal Health Alaris Pump Module

Audience: Hospital administrations, hospital risk managers, healthcare professionals

[UPDATE 01/11/2008] FDA informed healthcare professionals that the recall of all Alaris Infusion Pump modules (formerly Medley) shipped prior to September 27, 2007, has been classified as a Class I Recall.

[Posted 12/26/2007] Cardinal Health notified its customers of a voluntary recall for all Alaris Pump modules, model 8100 (formerly known as Medley Pump module), shipped prior to September 27, 2007. The recall covers Alaris Pump modules that were distributed to 46 States, the District of Columbia, Canada, Guam, Puerto Rico and Saudi Arabia. The pump module was recalled because the units may contain misassembled occluder springs (bent, broken, nested or missing) that occurred during manufacturing. Misassembled springs could lead to overinfusion that could result in serious adverse health consequences or death. Overinfusion may be difficult to detect because the misassembled springs can work intermittently, and there is no warning or notification of an overinfusion. See the manufacturer's press release for a list of the serial numbers for the affected devices and how the manufacturer will work with customers to minimize disruption while completing an inspection of the devices.

[January 11, 2008 - Recall Notice - FDA]
[December 26, 2007 - Press Release - Cardinal Health]