| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00280-2 |
| Product Name/Description |
ClaveGuard Diathermy Pencil
Batch Number: 18214SY
ARTG Number: 222138 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
ClaveGuard has been advised that Diathermy Pencils manufactured under batch number 181214SY have an issue with the quality of the ink used for the sterility check mark, which may compromise the ability to clearly discern the colour change. As a precautionary measure, ClaveGuard is recalling the affected batch. |
| Recall Action |
Recall |
| Recall Action Instructions |
The sponsor ClaveGuard advises customers to discontinue use of any remaining stock of the affected batch prior to their quarantine. The sponsor will arrange for the replacement and recovery of the affected units. This action has been closed-out on 16/02/2017. |
| Contact Information |
1300 283 122 - Dickson & Dickson Healthcare |