FDA Device recall Z-2735-2020
Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump
- FDA Device
- Class I
- ongoing
- Published 2020-08-12
On 2020-08-12 the FDA classified a Class I recall of Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump by Smiths Medical Asd, citing inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2735-2020 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2020-06-26 |
| Published | 2020-08-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Smiths Medical Asd |
| Distribution | n/a |
Product
Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
Reason
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Identifiers
| code_info | Model Numbers: 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82. Software Version V6.0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2735-2020%22
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