Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20985 |
| Brand Name: | Frenenuis Sleep safe Set |
| Model: | |
| Affected: | 5016921 sleeposafe Set, 5016931 sleeposafe Set Plus, 5017391 sleeposafe Set Paed |
| 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 Deutschland GmbH |
| Issue: | The manufacturer has become aware of leakages caused by overwelded coils on the patient and the drainage lines. Overwelded coils can lead to difficulties in unrolling the patient and drainage line and can result in rupturing the lines with pinholes and thus leakages may occur. |
| Recall action type: | Correction |
| Recall action: | Product to be exchanged |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 23/12/2016 |
