FDA Device recall Z-2734-2020
Medfusion Syringe Pump Model 4000
- 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 4000 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-2734-2020 |
| 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 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Reason
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Identifiers
| code_info | Model Numbers: 4000-0105-249, 4000-0105-50, 4000-0105-51, 4000-0105-78, 4000-0106-00, 4000-0106-01, and 4000-0106-231.…Model Numbers: 4000-0105-249, 4000-0105-50, 4000-0105-51, 4000-0105-78, 4000-0106-00, 4000-0106-01, and 4000-0106-231. Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1 |
|---|
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-2734-2020%22
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