Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29719 |
| Brand Name: | HLS |
| Model: | BE-HLS 7050 (SHLS Set Advanced 7.0), BE-HLS 5050 (SHLS Set Advanced 5.0), BO-HLS 7050 (S/HIT Set Advanced 7.0), BEQ-HLS 7050 USA (SHLS Set Advanced 7.0), BEQ-HLS 5050 USA (SHLS Set Advanced 5.0), BEQ-HLS 7050-CA (SHLS Set Advanced 7.0), |
| Affected: | Additional models: BEQ-HLS 5050-CA (SHLS Set Advanced 5.0), BE-HLS 7050 Japan (SHLS Set Advanced 7.0). |
| Software version: | |
| Recalling Organisation: | Getinge Australia Pty Ltd (NZ) Unit D, Ground Floor, Building A, Millenium Centre 600 Great South Rd Ellerslie Auckland 1051 |
| Contact Information: | 09 272 9039 |
| Manufacturer: | Maquet Cardio Pulmonary GmbH |
| Issue: | The manufacturer has received customer complaints of damage to the primary packaging of the HLS Set Advanced. In all customer complaints it was reported that the Tyvek cover was damaged. The appearance of the packaging failure can be hole(s) in the Tyvek. The damages are caused by the tabs of the venous probe holder within the packaging. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 3/7/2023 |
