Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21416 |
| Brand Name: | Sorin (Cellplex) Heater Cooler |
| Model: | |
| Affected: | Upgrade Kit |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | Cellplex Pty Ltd |
| Issue: | Manufacturer has completed the development of and obtained CE mark for a solution that mitigates against contamination by preventing dispersion of aerosols produced by the heater-cooler in the operating room. This solution will be implemented in manufacturing, and units currently in use in the field will undergo an upgrade on-site by the Obex Field Service Engineer. Although this solution is less necessary when the 3T device's water system is maintained according to the IFU, the field upgrade will mitigate against the reasonably foreseeable hazard of accidental contamination and poor maintenance practices. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Wholesale |
| Date Commenced: | 15/5/2017 |
