The Food and Drug Administration (FDA) has announced a Class I recall of certain Smiths Medical Syringe Pumps due to a risk of medication delivery errors.
Smiths Medical is recalling specific software versions of the Medfusion 3500 and 4000 Syringe Pumps because of a software error that may lead to over-delivery or under-delivery of fluids or medication. There have been 4 complaints regarding this device issue including 1 serious injury. There have been no deaths.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Food and Drug Administration (FDA). Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Pumps Due to Risk of Medication Delivery Error [news release]. August 25, 2020. Available at: click here. Accessed August 26, 2020.