Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 17069 |
| Brand Name: | Sorin 3T Heater Cooler with Remote |
| Model: | 16-02-80 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | Sorin Group Deutschland GmbH |
| Brand Name: | Sorin S3 Heater Cooler |
| Model: | 16-02-50 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | Sorin Group Deutschland GmbH |
| Issue: | Newly identified risk for cardiac surgery patients whereby some patients have been infected with a slow growing Mycobacterium chimaera. This organism is found in water including tap water sources. Important to review hygiene and surgical practices in the cardiac surgery theatre. This review should include sampling and monitoring programs for water sources solution preparations and systems that use water in the cardiac surgery theatre. Among these water systems, heater cooler device(s) need strict adherence to the cleaning disinfection and maintenance according to the operator manual for Sorin devices |
| Recall action type: | Alert |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 30/7/2014 |
