The United States Food and Drug Administration (FDA) has issued a Class I recall concerning Alaris Pump Module, Model 8100 (formerly Medley Pump Module), manufactured by CareFusion 303, Inc.
The manufacturer had identified that there is a potential for the pump module door keypad overlay to become loose, peel away, or separate from the door assembly with keypad part number TC10005926. This could cause a potential for fluid ingress which could lead to a keypad malfunction, causing the infusion to stop with alarm. When infusion stops, serious injury or death may result.
Customers were asked to visually examine the pump module keypad overlay for obvious signs of overlay separation.
For details, please refer to the following FDA websites
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm316612.htm
and
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm316637.htm.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 23 August 2012