Cardinal Health Updates Alaris Pump Module Recall
December 26th, 2007 amy
On December 20, the FDA announced that Cardinal Health issued the following update to the company’s worldwide recall for its Alaris Pump
module:
On Nov. 5, 2007, Cardinal Health notified customers of a voluntary recall for all Alaris Pump modules, model 8100 (formerly known as Medley Pump module), shipped prior to Sept. 27, 2007. Serial numbers for affected devices can be found at www.cardinalhealth.com/alaris/indexmodulealert.asp.
The reason for this recall is that the units may contain misassembled occluder springs (bent, broken, nested or missing). These conditions have occurred due to misassembly 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 company became aware of the issue from a review of customer complaints and service data. Cardinal Health has received one report of an injury and two reports of patient deaths associated with the use of this device. The deaths could not be confirmed by the respective hospitals or Cardinal Health as definitively caused by this issue.
Any customer inquiries related to this action should be addressed to Cardinal Health’s customer service center at 1-800-625-6627, with representatives available 24 hours a day, seven days a week.
Additional information about the recall can also be found at www.cardinalhealth.com/alaris/indexmodulealert.asp.
