The United States Food and Drug Administration (FDA) has issued a Class I recall concerning Alaris Pump Module, Model 8100, manufactured by CareFusion 303, Inc.
The manufacturer has identified a potential risk associated with the Alaris Pump module model 8100. CareFusion has received reports of customers experiencing motor stalls during infusion with Alaris Pump Module (model 8100) manufactured between August 2010 and July 2011. Most of the motor stalls reported appear to occur intermittently at high infusion rates (typically over 900 ml/hr) but CareFusion cannot rule out the possibility of occurrence at lower infusion rates.
According to the local supplier, the affected products were not distributed in Hong Kong.
For details, please refer to the following websites
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=55121&w=08222012&lang=eng
http://www.carefusion.com/customer-support/alerts-notices/medical-device-recall-alaris-pump-module-8100-intermittent-motor-stall.aspx.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 24 August 2012