| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00176-2 |
| Product Name/Description |
Haemoband PLUS
All lots affected
ARTG Number: 136643
(Horten Medical - Ligator, haemorrhoid) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
13/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
Horten Medical is re-issuing the Instructions for Use (IFU) document for the Haemoband Plus.
This Product Defect Correction was initiated as the Haemoband Plus, on one occasion, did not load the ligation band. There was no patient danger involved. As a result of this incident, Haemoband Surgical through Horten Medical have taken the decision to replace the Instructions for Use with an updated IFU, describing the procedure. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Horten Medical is providing updated Instructions for Use, and undertaking user training.
This action has been closed out on 21/01/2021 |
| Contact Information |
02 9736 3425 - Customer Service Support |