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.
FDA Recall Z-0996-2013 · Posted 2013-03-26
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Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2010-05-14
Date Terminated2013-04-11
Product Quantity6
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.
Firm Action
On May 14th, 2010, Smiths Medical contacted the facility that received the pumps via e-mail and requested that they immediately return the pumps. The pumps were returned per Returned Goods Authorization (RGA) and exchanged for replacement pumps manufactured with plunger rod seal G6000077.
Root Cause
Device Design
Distribution Pattern
Distributed in the state of NH.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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