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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01417-1
Product Name/Description	ProTrack Microcatheter Part number: CIC35-145 Lot Numbers: CIFA131113, CIFA100614, CIFA100714, CIFA241014 Part number: CIC38-145 Lot Numbers: CIFA161013, CIFA240614, CIFA.271113, CIFA100714, CIFA311213, CIFA180814, CIFA210214, CIFA080914, CIFA070314, CIFA.221014, CIFA270314, CIFA050115, CIFA070514, CIFA210115, CIFA210514, CIFA060215 ARTG Number: 185946
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	15/11/2017
Responsible Entity	Pacing Importers Pty Ltd
Reason/Issue	There is a chance that the affected catheters may have circumferential cracks along its length. If the cracks are present on the device, they are likely to be detected by a physician upon removal of the catheter from the packaging. The cracks may result in leakage of fluids along the catheter. There have been no adverse event reports related to this discovery.
Recall Action	Recall
Recall Action Instructions	Baylis Medical is advising users to inspect stock and quarantine any unused units for return. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	03 9525 5888 - Pacing Importers