Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16552 |
| Brand Name: | Baxter FOLFusor SV 0.5ml/hr |
| Model: | 2C4700K |
| Affected: | all lot numbers up to an including 14B039 |
| Software version: | |
| Recalling Organisation: | Baxter Healthcare Ltd 33 Vestey Drive Mt Wellington AUCKLAND |
| Contact Information: | 0800 229 837 |
| Manufacturer: | Baxter Healthcare SA (Switzerland) |
| Issue: | Manufacturer has continued to investigate complaints for over-infusion and wants to make customers aware that the direction insert states that infusion rates may be up to 10% greater than the nominal (labeled) infusion rate of 0.5ml/hr. Recent review of flow rate testing indicates that infusion rates may be higher and could result in a 15% greater than nominal (labeled) infusion rate. Baxter is considering options to bring the flow rate into alignment with curent labeling. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 17/4/2014 |
