| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00982-1 |
| Product Name/Description |
CARDIOHELP System
Multiple serial numbers
ARTG 179104
(Getinge Australia Pty Ltd - Heart-lung bypass system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
A noticeable high number of breaks in the insulation sheath and a shielding breach of multiple serial numbers of the venous probe connection cable for the Cardiohelp-i was observed. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised that their local Getinge representative will be in contact to arrange the replacement of the Venous Probe cable.
Affected CARDIOHELP-i are not requested to be returned and can be used as usual.
Customers are reminded to always report any adverse events, to their Getinge representative. |
| Contact Information |
1800 438 464 - Customer Service |