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.
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- May 14, 2010
- Posted
- March 26, 2013
- Terminated
- April 11, 2013
- Recall Number
- Z-0996-2013
- Quantity
- 6
- Firm Location
- Saint Paul, MN
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.
Distribution
Distributed in the state of NH.
Lot / Code Info
Lot/Serial Numbers: M76369, M76370, M76373, M76374, M76375, and M76377.
Root Cause
Device Design
Action Taken
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.
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