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Smiths Medical ASD, Inc. recalls Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the admi
Recalled April 3, 2013 · FDA recall Z-0996-2013 · Smiths Medical ASD
Hazard
An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions. · FDA Class II
Units
6
Sold at
Distributed in the state of NH.
Description
An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions.
Product
Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.
Manufacturer(s)
Smiths Medical ASD, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →