| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00374-1 |
| Product Name/Description |
Electrosurgery Probe Plus II (Electrosurgical electrodes) & Laparoscopic Banding Kit
Electrosurgery Probe Plus II Monopolar Electrosurgery Suction and Irrigation Shaft with:
Hook Electrode - 5 mm (Code: EPS01)
Spatula Electrode - 5 mm (Code: EPS02)
Right Angle Electrode - 5 mm (Code: EPS03)
ARTG Number: 125259
Electrosurgery Probe Plus II Suction and Irrigation Shaft - 10 mm ( Code: EPS 11)
ARTG Number: 124975
Laparoscopic Banding Kit ( Code: CK260)
ARTG Number: 99301 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential for the edge of the Probe Plus II rotational knob to rub against the Tyvek packaging, and in remote instances, puncture the Tyvek creating a pin hole and potentially compromising the sterility of the device. |
| Recall Action |
Recall |
| Recall Action Instructions |
Johnson & Johnson Medical is recalling the potentially affected products. |
| Contact Information |
1300 562 711 - Johnson & Johnson Medical Customer Service |