Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26497 |
| Brand Name: | Syringe Pump |
| Model: | Medfusion® 3500 - Firmware version - 6.0.0 and Medfusion® 4000- Firmware version - 1.5.0, 1.5.1, 1.6.0, 1.6.1, 1.7.0 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Smiths Medical Australasia Pty Ltd c/o KPMG, KPMG Centre 18 Viaduct Harbour Avenue Auckland |
| Contact Information: | 0800 444 200 |
| Manufacturer: | Smiths Medical ASD Inc |
| Issue: | The manufacturer has became aware of an unanticipated behavior in certain Medfusion® 3500 and 4000 Syringe Pumps. If a bolus or loading dose is interrupted and specific sequence of events occurs, inappropriate delivery (over or under-delivery of a bolus or loading dose) may occur. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 3/9/2020 |
