Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23436 |
| Brand Name: | Fresenius 4008 Bloodlines |
| Model: | 4008 Bloodlines |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Fresenius Medical Care Australia Pty Ltd (NZ) 12D Rennie Drive Mangere AUCKLAND 2022 |
| Contact Information: | 09 925 2700 |
| Manufacturer: | Fresenius Medical Care AG |
| Issue: | A number of leakages were reported at several locations on the 4008 bloodline tubing systems. Leakages on the bloodlines may cause blood loss into the environment and may lead to air intake into the system. While the air intake is normally detected by the dialysis machine's air detector, a leakage of blood may not be detected. Following the April 2018 Safety Alert (Medsafe Ref: 22357) issued for the 4008 bloodlines, the manufacturer has worked to change the 4008 bloodlines manufacturing process and has developed unaffected stock. |
| Recall action type: | Recall |
| Recall action: | Product to be exchanged |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 15/8/2018 |
