Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23537 |
| Brand Name: | Haemodialysis system - Lundia AB |
| Model: | AK98 Haemodialysis Devices |
| Affected: | |
| 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 identified a potential for AK 98 Haemodialysis Devices to generate excessive ultrafiltration (UF) in certain situations where treatment-related alarms occur, or where there is an ultrafilter leak. Excessive UF may present hazards for sensitive patients, such as low-weight patients, for whom target UF values of zero or very low volumes are desired. Due to the potential for excess fluid loss, when treating low-weight or other sensitive patients, weight loss should be monitored during treatment and the attached mitigating instructions should be followed. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 31/8/2018 |
