| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00432-1 |
| Product Name/Description |
Extension Tubing in Refill Kits for use with Synchromed pumps
Model number: 8551
ARTG number: 133764 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic Australasia Pty Limited is initiating a voluntary recall for a specific lot of our Model 8551 Refill Kits. Medtronic have identified that some refill kits in the affected lot may contain an extension tubing set that is occluded. Healthcare professionals may be unable to aspirate or fill the SynchroMed pumps using one of these affected refill kits. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is requesting their customers to identify and segregate devices from the affected lot. Return of stock will be organised by Medtronic Customer Service. |
| Contact Information |
1800 668 670 - Medtronic Customer Service |