Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20357 |
| Brand Name: | Sorin 1T /3T FlexTherm Systems |
| Model: | 16-02-50 16-02-80 16-02-91 16-02-82 16-02-83 16-02-85 16-02-95 and 16-70-00 |
| 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: | The Instructions for Use for the 1T and 3T/FlexTherm System prescribe the addition of 50ml and 150ml respectively of medical grade 3% hydrogen peroxide to the filtered tap water in the device, which results in a maximum concentration of approximately 330ppm. The purpose of adding the hydrogen peroxide is to prevent microbial growth between the regular cleaning / disinfection cycles performed every 2 weeks. The manufacturer has determined that plastic heat-exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow for diffusion of some quantity of hydrogen peroxide during a typical procedure |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/7/2016 |
