| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00511-1 |
| Product Name/Description |
Sorin 1T & 3T Heater Cooler
(Perfusion system)
All serial numbers starting with 16SXxxxx are affected
ARTG Number: 194514 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
16/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
Sorin has become aware that the actual disinfection practices and the water maintenance that some users have been performing are not always conducted according to our Instructions for Use. Without vigilant performance of the disinfection and maintenance procedures per the Instructions for Use, organisms can multiply in a heater cooler device and potentially form biofilm. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Sorin Group is providing end users with additional instructions for cases where the heater cooler has not been maintained according to the Instructions for Use. The IFU has also been updated to include the additional cleaning instructions. This action has been closed-out on 14/07/2016. |
| Contact Information |
03 9799 7444 Cellplex |