| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00252-1 |
| Product Name/Description |
FlexTherm Heater Cooler Device
Product Code: 16-70-00
Affected Serial Number in Australia: 16E01091
ARTG Number: 194514 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
After a thorough review of the FlexTherm Heater Cooler design, which has been marketed since June 2015 LivaNova has come to conclusion that the design concept does not fully meet user requirements. LivaNova has discontinued the production of the FlexTherm and does not intend to offer it again to the market in the future. |
| Recall Action |
Recall |
| Recall Action Instructions |
A LivaNova representative will contact the customer to agree on the return of the affected product. LivaNova will replace the affected product with a heater cooler HC3T including new connectors and tubing at no charge. Customers may continue to safely use the heater cooler devices in accordance with the Operator’s Manual and the supplied instructions below until the necessary device removal has been completed.
This action has been closed out on 21/09/2018 |
| Contact Information |
033 9799 7444 - LivaNova |