Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical ...
FDA Recall #Z-0996-2013 — Class II — May 14, 2010
Product Description
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.
Reason for Recall
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.
Recalling Firm
Smiths Medical ASD, Inc. — Saint Paul, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
6
Distribution
Distributed in the state of NH.
Code Information
Lot/Serial Numbers: M76369, M76370, M76373, M76374, M76375, and M76377.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated