Cardinal Health notified its customers of a voluntary recall for all Alaris Pump modules, Model 8100 (formerly known as the Medley Pump module) shipped before September 27, 2007. The product is an infusion pump used to dispense various medications. The recall covers Alaris Pump modules distributed to 46 U.S. states, the District of Columbia, Canada, Guam, Puerto Rico, and Saudi Arabia.

The pump module was recalled because the unit may contain occluder springs misassembled (bent, broken, nested, or missing) during manufacturing. Misassembled springs could lead to overinfusion, which 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 on the devices affected by this recall and for a description of how the manufacturer will work with customers to minimize disruption while completing an inspection of the devices.

Read the complete 2007 MedWatch Safety Summary including a link to the manufacturer's press release regarding this issue at http://www.fda.gov/medwatch/safety/2007/safety07.htm#cardinal.