| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00715-1 |
| Product Name/Description |
Mullins Transseptal Catheter Introducer 7 French Sheath
Model Number: 008551
Lot Number: 50693426
ARTG Number: 144139 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has identified a labelling issue for specific lots of the Mullins Transseptal Catheter Introducer Sheath in which packages labelled as Mullins 7F (French) may actually contain an 8F (French) dilator. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is requesting customers return all affected stock for replacement with unaffected stock. |
| Contact Information |
02 9857 9000 - Medtronic Australasia |