Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18055 |
| Brand Name: | Gambro AK200s and AK200 Ultra S Haemodialysis Monitors |
| Model: | |
| Affected: | All units |
| Software version: | |
| Recalling Organisation: | Gambro Pty Ltd (NZ) 5B Target Court Glenfield Auckland 0753 |
| Contact Information: | 021 966 006 |
| Manufacturer: | Gambro Lundia AB |
| Issue: | Gambro has received some complaints related to a technical error which will stop all the pumps and close the venous clamp. One section in the Operator's Manuals for the AK 200 S and the AK 200 ULTRA S instructs the user to contact technical service and to restart the blood pump to return the extracorporeal blood to the patient. Restarting the blood pump is however not possible, since the venous clamp is closed and the consequence will be a blood loss for the patient. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 10/2/2015 |
