| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00160-1 |
| Product Name/Description |
DLP Single Stage Venous Cannula with Metal Tip (Intended for the collection of deoxygenated blood from the superior and/or inferior vena cava during cardiopulmonary bypass)
Model Numbers: 69324, 69328, 69331
Lot Numbers: 2012121362, 2012121364, 2012121005 and 2012121063
ARTG Number: 155002 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
20/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has identified the potential for uncharacteristically rough metal edges, to occur along the inner diameter of the metal tip side ports of the cannula. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is asking customers to immediately quarantine all affected products and return it to Medtronic for credit. |
| Contact Information |
02 9857 9378 - Medtronic Regulatory Affairs |