| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00772-1 |
| Product Name/Description |
Edwards Pressure Monitoring Kit & Set, Model Number: PXMK2043
(used on patients requiring intravascular, intracranial, or intrauterine pressure monitoring)
Lot numbers: 59994210, 60001412, 60020166 & 60030868
ARTG Number: 142521 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
A flow restriction issue has been identified in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw. In either instance, the tubing can be exchanged for a new set. This may result in a procedural delay. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to check their inventory and quarantine any unused affected lots. Contact Edwards Customer Service to arrange for return of any unused product and obtain information about replacement product. This action has been closed-out on 17/08/2016. |
| Contact Information |
1800 222 601 - Edwards Customer Service |