Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26880 |
| Brand Name: | HLS Set |
| Model: | BE-HLS 7050 Article no 70104.7753, BE-HLS 5050 Article no70104.8127 |
| Affected: | |
| 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: | During verification testing and a review of customer complaints for the HLS Set Maquet Cardiopulmonary (MCP) identified a potential impairment of the sterile packaging barrier. Under the transport simulation verification tests, movements of the device and its accessories inside the plastic tray have been identified. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 12/11/2020 |
