Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24531 |
| Brand Name: | Therapeutic plasma exchange system |
| Model: | |
| Affected: | Prismaflex devices with software version 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 has received reports of Prismaflex 8.10 devices with inactive syringe pump during Continuous Renal Replacement Therapy (CRRT) treatment while using Regional Citrate Anticoagulation (RCA). It was determined that there is a potential for the calcium syringe pump to be inactive without the device alarming after a completed change syringe procedure. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 2/5/2019 |
