FDA-Device2013-04-03Class II
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.
Smiths Medical ASD, Inc.
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.
Sold states
Distributed in the state of NH.
Affected count
6
Manufactured in
1265 Grey Fox Rd, Saint Paul, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0996-2013Don't want to check this manually?
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