| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00417-1 |
| Product Name/Description |
Medtronic NIM Flex EMG Endotracheal Tube
Product numbers: 8229960, 8229965, 8229970, 8229975, 8229980, 8229985
Multiple lot numbers affected
ARTG Number: 169809 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
10/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
The tubes used to manufacture the NIM Flex Endotracheal Tube product may have the potential to delaminate. Such delamination can result in herniation of the inner lumen when the cuffs are overinflated. Such herniation can constrict the inner lumen of the endotracheal tube resulting in a reduction of airflow to the patient. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is requesting customers to return the affected lots. |
| Contact Information |
1800 668 670 - Medtronic Australasia |