Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21326 |
| Brand Name: | Gambro Prismaflex Control Unit |
| Model: | |
| Affected: | Prismaflex 4.11 Software Versions prior to 8.10, Prismaflex 6.10 ROW Software Versions prior to 8.10, Prismaflex 7.XX ROW Software Versions prior to 8.10 |
| Software version: | |
| Recalling Organisation: | Baxter Healthcare Ltd 33 Vestey Drive Mt Wellington AUCKLAND |
| Contact Information: | 0800 229 837 |
| Manufacturer: | Gambro Lundia AB |
| Issue: | The manufacturer will be releasing an updated software version of the Prismaflex Control Unit after receiving reports of device operators failing to adhere to the instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit. These steps are required to safely disconnect the patient before proceeding to unload the filter set after treatment. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 13/4/2017 |
