FDA Class I Recall: Smiths Medical Recalls Medfusion 3500 and 4000 Syringe

Feb. 11, 2021

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, announced the U.S. Food & Drug Administration (FDA). The FDA identified this as a Class I recall, the most serious type of recall because use of these devices may cause serious injuries or death.

Over- or under-delivery can occur if the following specific sequence of events occur: a bolus or loading dose is interrupted, the pump is primed, and the infusion is restarted. Use of the affected syringe pumps may cause serious adverse health consequences including death.

The Smiths Medical Medfusion Syringe Pump delivers blood, blood products, prescribed drugs, and other fluids into a patient's body in a controlled manner. Syringe pumps are primarily used in the neonatal and pediatric populations or in operating rooms and intensive care units for the adult population.

There have been four complaints regarding this device issue including one serious injury. There have been no deaths.

Recalled Product:

Medfusion Syringe Pumps, Model 3500, firmware version 6.0.0

Models 3500-0600-00, -01, -249, -51, -82

Model 4000, firmware version 1.5.0, 1.5.1, 1.6.0, 1.6.1, 1.7.0

Models 4000-0105-249, -50, -51, -78, 4000-0106-00, -01, -231

Manufacturing Dates: 5/2002 to present

Distribution Dates: 11/1/2013 to present

Devices Recalled in the U.S.: 46,395

Date Initiated by Firm: June 26, 2020

FDA has the recall.