Alaris Pump Module Recalled For Misassembled Occluder Springs
December 27th, 2007 amy
Cardinal Health has 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. The lengthy list of serial numbers affected by the recall can be found online at:
http://www.cardinalhealth.com/alaris/brochure/Serial_Number_Ranges_affected_by_the_recall.pdf
