| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00235-1 |
| Product Name/Description |
Medtronic NIM TriVantage EMG Endotracheal Tube
Model Numbers: 8229707 and 8229708
Lot Numbers: 0206035179 and 0206056078
ARTG Number: 169809 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic have determined that the TriVantage product may experience cuff leakage. Such leakage may result in intraoperative cuff deflation which then requires re-inflation or replacement of the deflated tube in order to ensure the continued ventilation of the patient. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is asking customers to return the affected stock for a replacement stock or credit. |
| Contact Information |
1800 668 670 - Medtronic Customer Service |