| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00186-1 |
| Product Name/Description |
BiCision (electrosurgical thermofusion and dissection system)
Lot / serial numbers:
W3174973
WO182954
W3177733
W3177734
W3179128
WN189444
W3176581
WN189947
ARTG Number: 94173 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
Internal investigations found very few Bicision instruments with the quality issue of low closing force of the jaw, which under unfavourable conditions could lead to insufficient thermofusion of large vessels or tissue bundles.
This recall action was carried out prior to review by the TGA. |
| Recall Action |
Recall |
| Recall Action Instructions |
Rymed is advising users to remove all affected devices from use. Return all affected devices to Rymed for credit or replacement when available. |
| Contact Information |
02 9676 3488 - Rymed |