Medfusion Model 3500 Syringe Pump — Class II medical device recall Z-0996-2013
Terminated recall by Smiths Medical ASD, Inc., reported 2013-04-03, distributed in NH. An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump
| Recall number | Z-0996-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Saint Paul, MN, United States |
| Recall initiated | 2010-05-14 |
| Classified | 2013-03-26 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2013-04-11 |
| Distributed | NH |
| Quantity | 6 |
| Reason classes | packaging |
| Serial numbers | M76369, M76370, M76373, M76374, M76375, M76377 |
| Model numbers | 3500, 3500-415, 3500-500 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0996-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.