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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01015-1
Product Name/Description HLS Cannulae (Used for the cannulation of suitable vessels during extra corporeal circulation as inflow or outflow cannula)

Multiple catalogue and lot numbers

ARTG Numbers: 188929 and 189286
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 2/10/2012
Responsible Entity Maquet Australia Pty Ltd
Reason/Issue In some very rare cases, it was not possible to insert the guide wire through the introducer of the HLS-Cannulae. The investigation identified that the hole in the grip of the introducer was partly blocked and the guide wire could not be pushed through. The problem occurs prior to vascular access and the cannulae itself functions properly during perfusion.
Recall Action Recall
Recall Action Instructions Quarantine and return affected devices to MAQUET
Contact Information 07 3339 3910 - MAQUET Regulatory Affairs