Medfusion Model 3500 Syringe Pump, Model #3500-415 and… recallZ-0996-2013 · Smiths Medical ASD, Inc. · initiated May 14, 2010
Class II Terminated All recalls posted in March 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical ASD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0996-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 14, 2010
- Posted by the FDA
- Mar 26, 2013
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 6
- Product code
- FRN
- FDA submissions
- K040899
- Distribution
- Distributed in the state of NH.
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.
Code information (models, lots, serial numbers)
Lot/Serial Numbers: M76369, M76370, M76373, M76374, M76375, and M76377.
Other devices under the same FDA submission
1 device cleared under K040899 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Medfusion 3500-500Icu Medical, Inc. · Pump, infusion2 recalls2 deaths1,884 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page