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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 Baxter Healthcare Pty Ltd
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