Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22718 |
| Brand Name: | Gambro Filter for ultrafiltration of water for intravenous |
| Model: | |
| Affected: | Product code 112062 |
| Software version: | |
| Recalling Organisation: | Baxter Healthcare Ltd 33 Vestey Drive Mt Wellington AUCKLAND |
| Contact Information: | 0800 229 837 |
| Manufacturer: | Gambro Dialysatoren GmbH & Co KG |
| Issue: | On March 28, 2018, the manufacturer issued an Urgent Device Correction Communication for the Ultrafilter U9000 due to reports of leaks during regular clinical use. In order to reduce the patient risk associated with the occurrence of leaks when the Ultrafilter is used in conjunction with AK96 and AK98 v1 dialysis machines, an update to the Instructions For Use (IFU) is in progress which will reduce the maximum lifetime usage to 60 days, or 100 disinfection cycles, with a maximum of 8 sodium carbonate and 12 sodium hypochlorite disinfection cycles. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 25/3/2019 |
