FDA Device recall Z-0996-2013
Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500
- FDA Device
- Class II
- terminated
- Published 2013-04-03
On 2013-04-03 the FDA classified a Class II recall of Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500 by Smiths Medical Asd, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0996-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2010-05-14 |
| Published | 2013-04-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Smiths Medical Asd |
| Distribution | NH |
Product
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
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.
Identifiers
| code_info | Lot/Serial Numbers: M76369, M76370, M76373, M76374, M76375, and M76377. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0996-2013%22
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