| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01070-1 |
| Product Name/Description |
Vented Paclitaxel Set (infusion set used during the administration of medication of anaesthetic drugs)
Product Code: MMC9627S
Lot Number: 14H13V434
ARTG Number: 108526 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
Baxter Healthcare has received reports of leaks at the spike's air vent subassembly.
A leak in a Paclitaxel set may result in a breach in sterility of the fluid path with subsequent contamination of the solution. If not detected during priming or initial set up, this may lead to serious adverse health consequences.
This leak may also result in potential skin contact which would result in potential skin irritation. |
| Recall Action |
Recall |
| Recall Action Instructions |
Baxter Healthcare is advising users to inspect and quarantine any affected stock for return to Baxter. This action has been closed-out on 31/08/2016. |
| Contact Information |
1300 789 646 - Baxter Healthcare Customer Service |