The United States Food and Drug Administration (FDA) has issued a Class I recall concerning all Medfusion model 4000 syringe infusion pumps with software versions V1.0 and V1.1 manufactured by Smiths Medical ASD, Inc.
According to the FDA, systems errors can cause the Medfusion 4000 infusion pump to go into an alarm condition and stop running, which can result in a delay or an interruption of patient therapy. For patient receiving critical therapy, a delay or interruption of therapy could result in serious injury and/or death.
For details, please refer to FDA website
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm314282.htm
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 3 August 2012